FDA Listing of Authorized Generics · FDA Listing of Authorized Generics as of March 28, 2018 ....

FDA Listing of Authorized Generics as of March 28, 2018

Note: This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications (NDAs). Because the annual reports seldom indicate the date an AG initially entered the market, the column headed “Date Authorized Generic Entered Market” reflects the period covered by the annual report in which the AG was first reported. Subsequent marketing dates by the same firm or other firms are not included in this listing. As noted, in many cases FDA does not have information on whether the AG is still marketed and, if not still marketed, the date marketing ceased. Although attempts have been made to ensure that this list is as accurate as possible, given the volume of data reviewed and the possibility of database limitations or errors, users of this list are cautioned to independently verify the information on the list. We welcome comments on and suggested changes (e.g., additions and deletions) to the list, but the list may include only information that is included in an annual report. Please send suggested changes to the list, along with any supporting documentation to: [email protected]

A B C D E F G H I J K L M N O P Q R S T U V X Y Z

Proprietary Name Dosage Form Strength NDA Applicant Name

Date Authorized Generic

Entered the Market

Date Authorized

Generic Ceased

Marketing 1 ACCOLATE Tablets 10 mg AstraZeneca

Pharmaceuticals 11/19/2010 Unknown

2 ACCOLATE Tablets 20 mg AstraZeneca Pharmaceuticals

11/19/2010 Unknown

3 ACCUPRIL Tablets 20 mg Pfizer Pharmaceuticals Ltd.

03/11/2004 Unknown

4 ACCUPRIL Tablets 40 mg Pfizer Pharmaceuticals Ltd.

03/11/2004 Unknown

5 ACCURETIC Tablets 10 mg/12.5 mg Pfizer 02/06/2006 Unknown

mailto:[email protected]



Entered the Market

Date Authorized

Generic Ceased

Marketing Pharmaceuticals Ltd.

6 ACCURETIC Tablets 20 mg/25 mg Pfizer Pharmaceuticals Ltd.

02/06/2006 Unknown

7 ACCURETIC Tablets 20 mg/12.5 mg Pfizer Pharmaceuticals Ltd.

02/06/2006 Unknown

8 ACEPHEN Suppositories 120 mg G & W Laboratories, Inc.

Prior to 1/1/1999 Unknown

9 ACETADOTE Injection 6g/30mL (200 mg/mL) Cumberland Pharmaceuticals, Inc.

1/7/2013 Unknown

10 ACTIGALL Capsules 300 mg Allergan Sales, LLC 08/13/2003 Unknown 11 ACTIQ Lozenge 400 mcg Cephalon, Inc. 09/26/2006 Unknown 12 ACTIQ Lozenge 600 mcg Cephalon, Inc. 09/26/2006 Unknown 13 ACTIQ Lozenge 800 mcg Cephalon, Inc. 09/26/2006 Unknown 14 ACTIQ Lozenge 1200 mcg Cephalon, Inc. 09/26/2006 Unknown 15 ACTIQ Lozenge 1600 mcg Cephalon, Inc. 09/26/2006 Unknown 16 ACTIQ Lozenge 200 mcg Cephalon, Inc. 09/26/2006 Unknown 17 ACTIVELLA Tablets 1 mg / 0.5 mg Amneal

Pharmaceuticals 2014 - 2015 Unknown

18 ACTIVELLA Tablets 0.5 mg / 0.1 mg Amneal Pharmaceuticals

2014 - 2015 Unknown

19 ACTONEL Tablets 150 mg Warner Chilcott Company LLC

06/2014 Unknown

20 ACTOPLUS-MET Tablets 15 mg/850 mg Takeda Pharmaceuticals USA

08/2013 - 07/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 21 ACTOPLUS-MET Tablets 15 mg/500 mg Takeda

Pharmaceuticals USA Unknown Unknown

22 ACTOS Tablets 30 mg Takeda Pharmaceuticals USA

08/17/2012 Unknown


08/17/2012 Unknown


08/17/2012 Unknown

25 ACULAR LS Ophthalmic Solution

0.4% Allergan, Inc. 11/11/2013 Unknown

26 ADALAT CC Extended-release Tablets

30 mg Alvogen Group Holdings LLC

04/21/1993 Unknown



04/21/1993 Unknown



04/21/1993 Unknown

29 ADDERALL XR Extended-release Capsules

5 mg Shire Development, LLC

12/17/2013 Unknown



09/30/2009 Unknown


20 mg Shire Development LLC

04/02/2009 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 32 ADDERALL XR Extended-

release Capsules


10/2016 - 10/2017 Unknown



10/2016 - 10/2017 Unknown



10/2016 - 10/2017 Unknown



10/2016 - 10/2017 Unknown



10/2016 - 10/2017 Unknown



04/02/2009 Unknown



04/02/2009 Unknown



09/30/2009 Unknown

40 ADDERALL XR Extended- 10 mg Shire Development, 09/30/2009 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing release Capsules

LLC



09/30/2009 Unknown



10/2016 - 10/2017 Unknown



09/30/2009 Unknown



04/02/2009 Unknown



04/02/2009 Unknown



04/02/2009 Unknown



04/02/2009 Unknown

48 ADDERALL XR Extended-release


04/02/2009 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Capsules



04/02/2009 Unknown



04/02/2009 Unknown



04/02/2009 Unknown



04/02/2009 Unknown

53 ADRENACLICK Injection 0.15 mg Amedra 04/01/2010 Unknown 54 ADRENACLICK Injection 0.3 mg Amedra 04/01/2010 Unknown 55 ALDACTAZIDE Tablets 25 mg/25 mg G.D. Searle LLC 10/06/2003 Unknown 56 ALDACTONE Tablets 25 mg G.D. Searle LLC 6/18/2003 Unknown 57 ALDACTONE Tablets 50 mg G.D. Searle LLC 6/18/2003 Unknown 58 ALDACTONE Tablets 100 mg G.D. Searle LLC 6/18/2003 Unknown 59 ALLEGRA Tablets 30 mg Sanofi Aventis US

LLC 02/2005 - 02/2006 Unknown

60 ALLEGRA Tablets 60 mg Sanofi Aventis US LLC

02/2005 - 02/2006 Unknown

61 ALLEGRA Tablets 180 mg Sanofi Aventis US 02/2005 - 02/2006 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing LLC

62 ALLEGRA-D 12 HOUR

Extended-release Tablets

60 mg/120 mg Sanofi Aventis US LLC

12/2004 - 12/2005 Unknown

63 AMARYL Tablets 1 mg Sanofi Aventis US LLC

11/2004 - 11/2005 Unknown


11/2004 - 11/2005 Unknown


11/2004 - 11/2005 Unknown

66 AMBIEN Tablets 5 mg Sanofi Aventis US LLC

12/2006 - 12/2007 Unknown

67 AMBIEN Tablets 10 mg Sanofi Aventis US LLC

12/2006 - 12/2007 Unknown

68 AMBIEN CR Extended-release Tablets

6.25 mg Sanofi Aventis U.S. LLC

10/2010 Unknown

69 AMBIEN CR Extended-release Tablets

12.5 mg Sanofi Aventis U.S. LLC

12/2010 Unknown

70 AMICAR Tablets 1000 mg Clover Pharmaceuticals Corporation

06/01/2012 Unknown

71 AMOXIL Powder for Oral Suspension

200 mg/5 mL when reconstituted

Dr. Reddy's Laboratories Inc.

04/15/1999 Unknown

72 AMOXIL Powder for Oral

400 mg/5 mL when reconstituted

Dr. Reddy's Laboratories Inc.

04/15/1999 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Suspension

73 AMOXIL Tablets 500 mg Dr. Reddy's Laboratories Inc.

07/10/1978 Unknown

74 AMOXIL Tablets 875 mg Dr. Reddy's Laboratories Inc.

07/10/1978 Unknown

75 ANAFRANIL Capsules 75 mg Mallinckrodt 07/2015 Unknown 76 ANAFRANIL Capsules 50 mg Mallinckrodt 07/2015 Unknown 77 ANAFRANIL Capsules 25 mg Mallinckrodt 07/2015 Unknown 78 ANCOBAN Capsules 250 mg Valeant

Pharmaceuticals North America LLC

07/2017 Unknown

79 ANCOBAN Capsules 500 mg Valeant Pharmaceuticals North America LLC

01/17/2012 Unknown

80 ANGIOMAX Injection 250 mg The Medicines Company

10/2015 Unknown

81 ANTARA Capsules 43 mg Lupin Atlantis Holdings, S.A.

02/22/2013 Unknown

82 ANTARA Capsules 130 mg Lupin Atlantis Holdings, S.A.

02/22/2013 Unknown

83 ARAVA Tablets 20 mg Sanofi Aventis US LLC

09/07/2015 Unknown

84 ARAVA Tablets 10 mg Sanofi Aventis US LLC

09/07/2015 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 85 ARICEPT Film coated

tablets 5 mg Eisai, Inc. 11/25/2009 - 11/24/2010 Unknown

86 ARICEPT Film coated tablets

10 mg Eisai, Inc. 11/25/2009 - 11/24/2010 Unknown

87 ARICEPT ODT Orally disintegrating tablets


88 ARICEPT ODT Orally distinegrating tablets


89 ARIXTRA Injection 7.5 mg / 0.6 mL Mylan Ireland Limited

12/2014 - 12/2015 Unknown

90 ARIXTRA Injection 5 mg / 0.4 mL Mylan Ireland Limited

12/2014 - 12/2015 Unknown

91 ARIXTRA Injection 10 mg / 0.8 mL Mylan Ireland Limited

12/2014 - 12/2015 Unknown

92 ARIXTRA Injection 2.5 mg / 0.5 mL Mylan Ireland Limited

12/2014 - 12/2015 Unknown

93 AROMASIN Tablets 25 mg Pharmacia & Upjohn 11/02/2010 Unknown 94 ARTHROTEC Tablets 50 mg/200 mcg GD Searle LLC 07/10/2011 Unknown 95 ARTHROTEC Tablets 75 mg/200 mcg GD Searle LLC 07/10/2011 Unknown 96 ASTELIN Nasal Spray 137 mcg Meda

Pharmaceuticals, Inc. 8/31/2010 Unknown

97 ATACAND Tablets 8 mg AstraZeneca 05/21/2013 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Pharmaceuticals

98 ATACAND Tablets 16 mg AstraZeneca Pharmaceuticals

05/21/2013 Unknown


05/21/2013 Unknown


05/21/2013 Unknown

101 ATIVAN Injection 2 mg/mL Baxter Healthcare Corporation

10/31/2003 Unknown

102 ATIVAN Injection 4 mg/mL Baxter Healthcare Corporation

10/31/2003 Unknown

103 ATRALIN Gel 0.05% Dow Pharmaceutical Sciences, a Divison of VPNA

07/26/2007 Unknown

104 ATRALIN Gel 0.05% Dow Pharmaceutical Sciences, a Division of VPNA

06/19/2014 Unknown

105 AUGMENTIN Oral Suspension

250 mg/62.5 mg per 5 mL Dr. Reddy's Laboratories Inc.

10/1990 Unknown



10/22/1990 Unknown


400 mg/57 mg per 5 mL Dr. Reddy's Laboratories Inc.

10/22/1990 Unknown

108 AUGMENTIN Tablets 250 mg Dr. Reddy's Laboratories Inc.

10/22/1990 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 109 AUGMENTIN Tablets 500 mg Dr. Reddy's

Laboratories Inc. 10/22/1990 Unknown

110 AUGMENTIN Tablets 875 mg Dr. Reddy's Laboratories Inc.

10/02/1996 Unknown

111 AUGMENTIN ES-600 Powder for Oral Suspension


06/22/2001 Unknown

112 AVALIDE Tablets 300 mg/12.5 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 113 AVALIDE Tablets 150 mg/12.5 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 114 AVAPRO Tablets 150 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 115 AVAPRO Tablets 75 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 116 AVAPRO Tablets 300 mg Sanofi-Aventis LLC 09/01/2011 - 08/31/2012 Unknown 117 AVELOX Tablets 400 mg Bayer HealthCare

Pharmaceuticals Unknown Unknown

118 AVITA Cream 0.025% Mylan Pharmaceuticals, Inc.

05/01/1998 Unknown

119 AXERT Tablets 12.5 mg Janssen Research & Development, LLC

07/2015 Unknown

120 AXERT Tablets 6.25 mg Janssen Research & Development, LLC

07/2015 Unknown

121 AZILECT Tablets 0.5 mg Teva Neuroscience, Inc.

01/2017 Unknown

122 AZILECT Tablets 1 mg Teva Neuroscience, Inc.

01/2017 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 123 AZOR Tablets 10 mg/ 20 mg Daiichi Sankyo Inc. 10/2016 Unknown 124 AZOR Tablets 5 mg/ 40 mg Daiichi Sankyo Inc. 10/2016 Unknown 125 AZOR Tablets 10 mg/ 40 mg Daiichi Sankyo Inc. 10/2016 Unknown 126 AZOR Tablets 5 mg/20 mg Daiichi Sankyo Inc. 10/2016 Unknown 127 AZULFIDINE Tablets 500 mg Pharmacia and

Upjohn Company 07/14/2003 Unknown

128 AZULFIDINE EN-TABS

Delayed-release Tablets

500 mg Pharmacia and Upjohn Company

06/17/2003 Unknown

129 BENICAR Tablets 5 mg Daiichi Sankyo, Inc 10/2016 Unknown 130 BENICAR Tablets 40 mg Daiichi Sankyo, Inc 10/2016 Unknown 131 BENICAR Tablets 20 mg Daiichi Sankyo, Inc 10/2016 Unknown 132 BENICAR HCT Tablets 40 mg/12.5 mg Daiichi Sankyo, Inc 10/2016 Unknown 133 BENICAR HCT Tablets 40 mg/25 mg Daiichi Sankyo, Inc 10/2016 Unknown 134 BENICAR HCT Tablets 20 mg/12.5 mg Daiichi Sankyo, Inc 10/2016 Unknown 135 BENZACLIN Topical Gel 1% / 5% Valeant

Pharmaceuticals North Americal LLC

05/2017 Unknown

136 BENZAMYCIN Topical Gel 3% Erythromycin, 5% Benzoyl Peroxide

Valeant Pharmaceuticals North America LLC

10/2014 - 10/2015 Unknown

137 BENZAMYCIN Topical Gel 3% Erythromycin, 5% Benzoyl Peroxide

Valeant Pharmaceuticals North America LLC

10/26/1984, 05/07/2013 Unknown

138 BETAGAN Ophthalmic 0.5% Allergan, Inc. 07/15/1997 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Solution

139 BETAGAN Ophthalmic Solution

0.25% Allergan, Inc. 07/15/1997 Unknown

140 BETOPTIC Ophthalmic Solution

eq. 0.5% base Alcon Laboratories, Inc.

05/08/2000 Unknown

141 BIAXIN Granules for Oral Suspension

250 mg per 5 mL when reconstituted (100 mL bottle)

AbbVie Inc. 05/2012 Unknown

142 BIAXIN Granules for Oral Suspension

125 mg per 5 mL when reconstituted (50 mL bottle)

AbbVie Inc. 05/2012 Unknown

143 BLOCADREN Tablets 5 mg Merck & Co., Inc. Prior to 1/1/1999 Unknown 144 BLOCADREN Tablets 10 mg Merck & Co., Inc. Prior to 1/1/1999 Unknown 145 BREVIBLOC Injection 10 mg/mL Baxter Healthcare

Corporation 11/2002 - 10/2003 Unknown

146 BROMDAY Ophthalmic Solution

0.09% Bausch & Lomb Inc. 10/16/2013 Unknown

147 BUMEX Tablets 0.5 mg Validus Pharmaceuticals LLC

10/2015 Unknown

148 BUMEX Tablets 1 mg Validus Pharmaceuticals LLC

10/2015 Unknown

149 BUMEX Tablets 2 mg Validus Pharmaceuticals LLC

10/2015 Unknown

150 BUTRANS Transdermal 15 mcg/hour Purdue Pharma L.P. 05/2017 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing System

151 BUTRANS Transdermal System

20 mcg/hour Purdue Pharma L.P. 05/2017 Unknown





154 CADUET Tablet 5 mg/80 mg PF Prism C.V. 11/3/2011 Unknown 155 CADUET Tablet 2.5 mg/20 mg PF Prism C.V. 11/3/2011 Unknown 156 CADUET Tablet 2.5 mg/10 mg PF Prism C.V. 04/04/2014 Unknown 157 CADUET Tablet 5 mg/10 mg PF Prism C.V. 04/04/2014 Unknown 158 CADUET Tablet 5 mg/40 mg PF Prism C.V. 04/04/2014 Unknown 159 CADUET Tablet 10 mg/40 mg PF Prism C.V. 11/3/2011 Unknown 160 CADUET Tablet 2.5 mg/10 mg PF Prism C.V. 11/3/2011 Unknown 161 CADUET Tablet 2.5 mg/20 mg PF Prism C.V. 04/04/2014 Unknown 162 CADUET Tablet 10 mg/10 mg PF Prism C.V. 11/3/2011 Unknown 163 CADUET Tablet 5 mg/20 mg PF Prism C.V. 11/3/2011 Unknown 164 CADUET Tablet 2.5 mg/40 mg PF Prism C.V. 11/3/2011 Unknown 165 CADUET Tablet 2.5 mg/40 mg PF Prism C.V. 04/04/2014 Unknown 166 CADUET Tablet 5 mg/10 mg PF Prism C.V. 11/3/2011 Unknown 167 CADUET Tablet 10 mg/20 mg PF Prism C.V. 11/3/2011 Unknown 168 CADUET Tablet 5 mg/20 mg PF Prism C.V. 04/04/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 169 CADUET Tablet 10 mg/80 mg PF Prism C.V. 11/10/2011 Unknown 170 CADUET Tablet 5 mg/80 mg PF Prism C.V. 04/04/2014 Unknown 171 CADUET Tablet 10 mg/10 mg PF Prism C.V. 04/04/2014 Unknown 172 CADUET Tablet 5 mg/40 mg PF Prism C.V. 11/3/2011 Unknown 173 CADUET Tablet 10 mg/80 mg PF Prism C.V. 04/04/2014 Unknown 174 CADUET Tablet 10 mg/40 mg PF Prism C.V. 04/04/2014 Unknown 175 CADUET Tablet 10 mg/20 mg PF Prism C.V. 04/04/2014 Unknown 176 CARAC Cream 0.5% Valeant

Pharmaceuticals North America LLC

10/28/2014 Unknown

177 CARAFATE Tablets 1 g Allergan Sales, LLC 11/01/1996 Unknown 178 CARBATROL Extended-

Release Capsules


12/15/2011 Unknown

179 CARBATROL Extended-Release Capsules


12/15/2011 Unknown

180 CARBATROL Extended-Release Capsules


12/15/2011 Unknown

181 CARDIOLITE Injection (per label) Lantheus Medical Imaging, Inc.

12/1990 Unknown

182 CARDIZEM Tablets 30 mg Valeant Pharmaceuticals




Entered the Market

Date Authorized

Generic Ceased

Marketing North American LLC

183 CARDIZEM Tablets 60 mg Valeant Pharmaceuticals North American LLC






186 CARDIZEM CD Capsules 360 mg Valeant Pharmaceuticals North America, LLC

08/09/2012 Unknown

187 CARDIZEM LA Tablets 420 mg Valeant Pharmaceuticals North America, LLC

02/06/2014 Unknown


02/06/2014 Unknown


02/06/2014 Unknown


02/06/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 191 CARDIZEM LA Tablets 300 mg Valeant

Pharmaceuticals North America, LLC

02/06/2014 Unknown

192 CARNITOR Oral Solution 1 gm/10 mL Sigma-Tau Pharmaceuticals, Inc.

04/2005 - 04/2006 Unknown

193 CARNITOR Tablets 330 mg Sigma-Tau Pharmaceuticals, Inc.

1/2005 - 12/2005 Unknown

194 CEDAX Capsules 400 mg Pernix Therapeutics LLC

10/22/2013 Unknown

195 CEDAX Powder, for Oral Suspension

60 mL when reconstituted (180 mg per 5 mL)

Pernix Therapeutics LLC

10/22/2013 Unknown

196 CELEBREX Capsules 200 mg G.D. Searle, LLC 12/10/2014 Unknown 197 CELEBREX Capsules 100 mg G.D. Searle, LLC 12/10/2014 Unknown 198 CELEBREX Capsules 100 mg G.D. Searle, LLC 12/10/2014 Unknown 199 CELEBREX Capsules 100 mg G.D. Searle, LLC 12/10/2014 Unknown 200 CELEBREX Capsules 200 mg G.D. Searle, LLC 12/10/2014 Unknown 201 CELEBREX Capsules 200 mg G.D. Searle, LLC 12/10/2014 Unknown 202 CELEBREX Capsules 400 mg G.D. Searle, LLC 12/10/2014 Unknown 203 CELEBREX Capsules 200 mg G.D. Searle, LLC 12/10/2014 Unknown 204 CELEBREX Capsules 50 mg G.D. Searle, LLC 12/10/2014 Unknown 205 CHILDREN'S

MOTRIN Suspension 100 mg/5 mL McNeil Consumer

Healthcare 06/1998 - 06/1999 Unknown

206 CHILDREN'S Suspension/ 40 mg/mL McNeil Consumer Prior to 1/1/1999 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing MOTRIN (aka INFANT'S MOTRIN)

Drops Healthcare

207 CILOXAN Ophthalmic Solution

0.3% Novartis Pharmaceuticals Corporation

05/28/2004 Unknown

208 CIPRO for Oral Suspension

250 mg/5 mL Bayer Pharmaceuticals Corp.

06/2003 Unknown

209 CIPRO for Oral Suspension

500 mg/5 mL Bayer Pharmaceuticals Corp.

06/2003 Unknown

210 CIPRO Tablets eq. 250 mg base Bayer Pharmaceuticals Corp.






213 CLEOCIN Vaginal Cream

2% Pharmacia and Upjohn Company

12/17/2005 Unknown

214 CLEOCIN HCl Capsules 150 mg Pharmacia and Upjohn Company

07/11/2003 Unknown

215 CLEOCIN HCl Capsules 300 mg Pharmacia and Upjohn Company

06/18/2003 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 216 CLEOCIN

PEDIATRIC Flavored Granules for Oral Solution

75 mg/5 mL (100 mL when mixed)

Pharmacia and Upjohn Company

07/28/2010 Unknown

217 CLEOCIN T Topical Gel 1% Pharmacia and Upjohn Company

06/11/2003 Unknown

218 CLEOCIN T Topical Lotion 1% Pharmacia and Upjohn Company

06/18/2003 Unknown

219 CLEOCIN T Topical Solution

1% Pharmacia and Upjohn Company

06/11/2003 Unknown

220 CLINORIL Tablets 150 mg Merck & Co., Inc. Prior to 1/1/1999 Unknown 221 CLINORIL Tablets 200 mg Merck & Co., Inc. Prior to 1/1/1999 Unknown 222 CLOBEX Emulsion,

Lotion 0.05% Galderma

Laboratories, L.P. 01/03/2012 Unknown

223 CLOBEX Shampoo 0.05% Galderma Laboratories

12/2011 Unknown

224 CLOBEX Spray 0.05% Galderma Laboratories, L.P.

08/2015 Unknown

225 CLODERM Cream 0.1% Promius Pharma, LLC

02/17/2014 Unknown

226 CLOLAR Injection 20mg/20mL Genzyme Corporation

05/2017 Unknown

227 CLOMID Tablets 50 mg Hoechst Marion Roussel, Inc.


228 CLOZARIL Tablets 25 mg Heritage Life Sciences 09/2017 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing (USA), Inc.

229 CLOZARIL Tablets 100 mg Heritage Life Sciences (USA), Inc.

09/2017 Unknown

230 COGENTIN Injection 2 mg/2 mL (2 mL ampule)

Oak Pharmaceuticals 08/08/2012 Unknown

231 COLAZAL Capsules 750 mg Salix Pharmaceuticals, Inc.

01/2008 Unknown

232 COLCRYS Tablets 0.6 mg Takeda Pharmaceuticals U.S.A. Inc.

01/09/2015 Unknown

233 COLESTID Granules for Oral Suspension

5 g per dose Pharmacia and Upjohn Company

01/11/2016 Unknown

234 COLESTID Tablets 1 g Pharmacia and Upjohn

02/2007 Unknown

235 COLY-MYCIN M for Injection 150 mg/vial (single dose vial)

Par Sterile Products, LLC

06/01/2012 Unknown

236 COLYTE for Oral Solution

240 gm/bot; 5.84 gm/bot; 2.98 gm/bot; 6.72 gm/bot; 22.72 gm/bot

Meda Pharmaceuticals Inc.

10/1996 Unknown

237 COMTAN Tablets 200 mg Orion Corporation 6/26/2013 Unknown 238 COMTAN Tablets 200 mg Orion Corporation 10/1/2012 Unknown 239 COMTAN Tablets 200 mg Orion Corporation 4/1/2013 Unknown 240 COMTAN Tablets 200 mg Orion Corporation 06/04/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 241 CONCERTA Extended-

release Tablets 18 mg Janssen Research and

Development, LLC 5/1/2011 Unknown

242 CONCERTA Extended-release Tablets

27 mg Janssen Research and Development, LLC

5/1/2011 Unknown



5/1/2011 Unknown



5/1/2011 Unknown

245 CONDYLOX Topical Solution

0.5% Allergan Sales, LLC 12/16/2003 Unknown

246 CONZIP Extended-release Capsules

200 mg Cipher Pharmaceuticals, Inc.

05/2015 Unknown



06/2015 Unknown



06/2015 Unknown



06/2012 Unknown

250 CORGARD Tablets 80 mg US WorldMeds, LLC 05/05/2014 Unknown 251 CORGARD Tablets 40 mg US WorldMeds, LLC 05/05/2014 Unknown 252 CORGARD Tablets 20 mg US WorldMeds, LLC 05/05/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 253 CORTEF Tablets 10 mg Pharmacia and

Upjohn Company LLC

12/21/2012 Unknown

254 CORTEF Tablets 5 mg Pharmacia and Upjohn Company LLC

12/21/2012 Unknown

255 CORTEF Tablets 20 mg Pharmacia and Upjohn Company LLC

12/22/2012 Unknown

256 CORTENEMA Rectal Suspension

100 mg/60 mL ANI Pharmaceuticals, Inc.

08/2012 Unknown

257 CORTISPORIN OTIC Otic Solution eq. 3.5 mg base/g; 10,000 units/g; 1%

Monarch Pharmaceuticals Inc.

1/11/1999 Unknown

258 COSMEGEN Powder, for injection solution, lyophilized

500 mcg (0.5 mg) Recordati Rare Diseases Inc.

12/2017 Unknown

259 COZAAR Tablet, Film Coated

25 mg Merck Sharp & Dohme Corp.

4/6/2010 Unknown



4/6/2010 Unknown



4/6/2010 Unknown

262 CUTIVATE Cream 0.05% GlaxoSmithKline Consumer

11/2003 - 11/2004 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Healthcare

263 CUTIVATE Lotion 0.05% Fougera Pharmaceuticals, Inc.

10/05/2009 Unknown

264 CUTIVATE Ointment 0.005% GlaxoSmithKline Consumer Healthcare

11/2003 - 11/2004 Unknown

265 CYCLESSA Tablets 0.1 mg, 0.125 mg, 0.15 mg; 0.025 mg, 0.025 mg, 0.025 mg

Organon USA Inc. 9/15/2004 Unknown

266 CYTOTEC Tablets 200 mcg GD Searle LLC 06/18/2003 Unknown 267 CYTOTEC Tablets 100 mcg GD Searle LLC 06/18/2003 Unknown 268 DANTRIUM Capsules 50 mg Par Sterile Products,

LLC 04/08/2013 Unknown

269 DANTRIUM Capsules 100 mg Par Sterile Products, LLC

02/2016 Unknown

270 DANTRIUM Capsules 25 mg Par Sterile Products, LLC

04/08/2013 Unknown

271 DAYPRO Tablets 600 mg GD Searle LLC 03/28/2013 Unknown 272 DDAVP Nasal Solution 0.1 mL (10 mcg) per

actuation Ferring Pharmaceuticals, Inc.

07/2016 Unknown

273 DDAVP Tablets 0.1 mg Ferring Pharmaceuticals, Inc.

12/2015 Unknown

274 DDAVP Tablets 0.2 mg Ferring Pharmaceuticals, Inc.

12/2015 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 275 DDAVP,

DESMOPRESSIN ACETATE

Injection 4 mcg/mL Ferring Pharmaceuticals Inc.

01/2016 Unknown

276 DELESTROGEN Injection 20 mg/mL Par Sterile Products 06/01/2012 Unknown 277 DELESTROGEN Injection 40 mg/mL Par Sterile Products 06/01/2012 Unknown 278 DELESTROGEN Injection 10 mg/mL Par Sterile Products 06/01/2012 Unknown 279 DEPAKOTE ER Extended-

release Tablets 250 mg Abbvie Inc. 08/2013 Unknown

280 DEPAKOTE ER Extended-release Tablets

500 mg Abbvie Inc. 08/2013 Unknown

281 DEPAKOTE SPRINKLE CAPSULES

Capsules 125 mg AbbVie Inc. 08/31/2015 Unknown

282 DEPO-MEDROL Injection 40 mg/mL Pharmacia and Upjohn

05/2006 - 05/2007 Unknown

283 DEPO-MEDROL Injection 80 mg/mL Pharmacia and Upjohn

05/2006 - 05/2007 Unknown

284 DEPO-PROVERA Injection 150 mg/mL Pharmacia and Upjohn

09/16/2004 Unknown

285 DERMA-SMOOTHE/FS

Oil 0.01% Hill Dermaceuticals Inc.

08/20/2013 Unknown

286 DERMATOP EMOLLIENT CREAM

Cream 0.1% Valeant Pharmaceuticals North America, LLC

10/2006 - 10/2007 Unknown

287 DERMOTIC Oil 0.01% Hill Dermaceuticals Unknown Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Inc.

288 DESMOPRESSIN ACETATE

Nasal Spray 10 mcg per 0.1 mL (5 mL bottle)

Ferring Pharmaceuticals, Inc.

11/20/2014 Unknown

289 DESOWEN Cream 0.05% Galderma Laboratories, L.P.

07/2013 Unknown

290 DETROL Tablets 1 mg Pharmacia and Upjohn

01/23/2014 Unknown


01/23/2014 Unknown


06/7/2012, 03/13/2015 Unknown


06/07/2012, 03/13/2015 Unknown

294 DETROL LA Extended-release Capsules

4 mg Pharmacia and Upjohn

01/02/2014 Unknown

295 DETROL LA Extended-release Capsules


01/02/2014 Unknown

296 DEXEDRINE SPANSULE

Extended-release Capsules

15 mg Impax Laboratories, Inc.

08/02/1976 Unknown

297 DEXEDRINE SPANSULE

Extended-release Capsules


08/02/1976 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 298 DEXEDRINE

SPANSULE Extended-release Capsules


08/02/1976 Unknown

299 DIABETA Tablets 1.25 mg Sanofi-Aventis U.S., LLC

05/01/1984 Unknown

300 DIAMOX SEQUELS ER Capsules 500 mg Teva Branded Pharmaceuticals USA, Inc.

12/2008 Unknown

301 DIASTAT Gel 20 mg Valeant Pharmaceuticals North America LLC

09/03/2010 Unknown

302 DIASTAT Gel 10 mg Valeant Pharmaceuticals North America LLC

09/03/2010 Unknown

303 DIASTAT Gel 2.5 mg Valeant Pharmaceuticals North America LLC

10/01/2010 Unknown

304 DIAZEPAM Gel 20 mg Valeant Pharmaceuticals North America, LLC

09/03/2010 Unknown

305 DIAZEPAM Gel 10 mg Valeant Pharmaceuticals North America, LLC

09/03/2010 Unknown

306 DIAZEPAM Gel 2.5 mg Valeant Pharmaceuticals

09/03/2010 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing North America, LLC

307 DIBENZYLINE Capsules 10 mg Concordia Pharmaceuticals Inc.

08/11/2015 Unknown

308 DIFFERIN GEL 0.1% Gel 0.1% Galderma Laboratories, L.P.

08/23/2010 Unknown


01/2014 Unknown


09/2009 Unknown

311 DIFFERIN LOTION 0.1%

Lotion 0.1% Galderma Laboratories, L.P.

03/2010 Unknown

312 DIFLUCAN Powder for Oral Suspension

10 mg/mL when reconstituted

Pfizer Inc. 03/12/2004 Unknown

313 DIFLUCAN Powder for Oral Suspension

40 mg/mL when reconstituted


314 DIFLUCAN Tablets 50 mg Pfizer Inc. 03/12/2004 Unknown 315 DIFLUCAN Tablets 100 mg Pfizer Inc. 03/12/2004 Unknown 316 DIFLUCAN Tablets 150 mg Pfizer Inc. 03/12/2004 Unknown 317 DIFLUCAN Tablets 200 mg Pfizer Inc. 03/12/2004 Unknown 318 DILANTIN Tablet

(INFATABS) 50 mg Parke-Davis Division

of Pfizer Inc. 12/27/2012 Unknown

319 DILANTIN-125 Oral 125 mg/5 mL (237 mL Parke-Davis Division 6/13/2012 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Suspension bottle) of Pfizer Inc.

320 DILAUDID Solution 5 mg/5 mL (1 mg/mL) Rhodes Pharmaceuticals L.P.

10/1/2012 Unknown

321 DILAUDID Tablets 4 mg Rhodes Pharmaceuticals L.P.

11/23/2009 Unknown


11/23/2009 Unknown


11/23/2009 Unknown

324 DIPROLENE Ointment 0.05% Merck Sharp & Dohme Corporation

8/10/2012 Unknown

325 DITROPAN XL Extended-release Tablets


11/12/2015 Unknown

326 DITROPAN XL Extended-release Tablets


11/12/2015 Unknown

327 DIURIL Injection 500 mg/vial, sterile lyophilized

Oak Pharmaceuticals Inc.

08/13/2012 Unknown

328 DOLOPHINE Tablets 10 mg West-Ward Pharmaceuticals Corp.

1999 - 2000 Unknown

329 DOLOPHINE Tablets 5 mg West-Ward Pharmaceuticals Corp.

1999 - 2000 Unknown

330 DORAL Tablets 15 mg Galt Pharmaceuticals, LLC

8/8/13 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 331 DORIBAX Powder for

Injection 500 mg/vial Shionogi Inc. 12/2016 Unknown

332 DORIBAX Powder for Injection

250 mg/vial Shionogi Inc. 12/2016 Unknown

333 DORYX Delayed-Release Tablets

150 mg Mayne Pharma International Pty Ltd.

07/08/2013 Unknown



07/08/2013 Unknown



07/08/2013 Unknown



2016 Unknown



Unknown Unknown

338 DOSTINEX Tablets 0.5 mg Pharmacia and Upjohn

09/22/2014 Unknown

339 DOVONEX Cream 0.005% LEO Pharma Inc. 2012 Unknown 340 DOVONEX Ointment 0.005% LEO Pharma Inc. 07/01/2013 Unknown 341 DOXIL Injection

(Liposomal 20 mg/10 mL single use vial

Janssen Research & Development, LLC

07/2017 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing formulation)

342 DOXIL Injection (Liposomal formulation)

50 mg/25 mL single use vial

Janssen Research & Development, LLC

07/2017 Unknown

343 DOXORUBICIN Injection 50 mg/25 mL Pharmacia and Upjohn

03/17/2014 Unknown

344 DOXORUBICIN Injection 20 mg/10mL Pharmacia and Upjohn

03/17/2014 Unknown


03/17/2014 Unknown

346 DOXORUBICIN Injection 200 mg/ 100 mL Pharmacia and Upjohn

03/17/2014 Unknown


4/1/2013 Unknown


4/1/2013 Unknown


4/1/2013 Unknown


4/1/2013 Unknown


4/1/2013 Unknown

352 DRISDOL Capsules 1.25 mg (50,000 IU) Sanofi Aventis US LLC

11/10/2009 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 353 DUAC Topical Gel 1.2% Clindamycin

Phosphate, 5% Benzoyl Peroxide

Stiefel Laboratories, Inc.

06/27/2012 Unknown

354 DUETACT Tablets 30 mg / 2 mg Takeda Pharmaceuticals U.S.A., Inc.

08/04/2015 Unknown

355 DUETACT Tablets 30 mg / 4 mg Takeda Pharmaceuticals U.S.A., Inc.

08/04/2015 Unknown

356 DURAGESIC-100 Transdermal System

100 mcg/h Janssen Research & Development, LLC

2009 Unknown



2009 Unknown



2009 Unknown



2009 Unknown



2009 Unknown

361 DUTOPROL Tablets 25/12.5 mg Concordia Pharmaceuticals Inc.

08/2017 Unknown

362 DUTOPROL Tablets 100/12.5 mg Concordia Pharmaceuticals Inc.

08/2017 Unknown

363 EDECRIN Tablets 25 mg Aton Pharma, Inc. 01/2016 - 01/2017 Unknown 364 EFFEXOR XR Extended- 150 mg Wyeth 6/1/2008 Unknown



Entered the Market

Date Authorized

Generic Ceased


Pharmaceuticals

365 EFFEXOR XR Extended-release Capsules

37.5 mg Wyeth Pharmaceuticals

6/1/2008 Unknown

366 EFFEXOR XR Extended-release Capsules

75 mg Wyeth Pharmaceuticals

6/1/2008 Unknown

367 EFUDEX Cream 5% Topical Cream Valeant Pharmaceuticals International, Inc.

09/2006 Unknown

368 ELDEPRYL Capsules 5 mg Somerset Pharmaceuticals, Inc.

05/1998 - 05/1999 Unknown

369 ELDEPRYL Tablets 5 mg Somerset Pharmaceuticals, Inc.

06/1999 - 06/2000 Unknown

370 ELOXATIN Injection 100 mg / 20 mL (5 mg/mL)

Sanofi-Aventis US LLC

07/07/2014 Unknown

371 ELOXATIN Injection 50 mg / 10 mL (5 mg/mL) Sanofi-Aventis US LLC

07/07/2014 Unknown

372 ELOXATIN (PREMIERPro)

Injection 100 mg / 20 mL (5 mg/mL)

Sanofi-Aventis US LLC

10/2015 Unknown

373 ELOXATIN (PREMIERPro)

Injection 50 mg/10 mL (5 mg/mL) Sanofi-Aventis US LLC

10/2015 Unknown

374 EMLA Cream 2.5% and 2.5% Actavis Laboratories UT, Inc.

11/12/2012 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 375 ENTOCORT EC Capsules 3 mg Paddock Laboratories,


376 EPIDUO Topical Gel 0.1% / 2.5% Galderma Laboratories, L.P.

08/2017 Unknown

377 EPIPEN Injection 0.3 mg/0.3 mL Mylan Specialty L.P. 12/15/2016 Unknown 378 EPIPEN JR. Injection 0.15/0.3 mL Mylan Specialty L.P. 12/15/2016 Unknown 379 EPIVIR-HBV Tablets 100 mg GlaxoSmithKline 09/05/2014 Unknown 380 EPZICOM Tablets 600 mg and 300 mg ViiV Healthcare

Company 09/2016 Unknown

381 ERYC Delayed-Release Capsules

250 mg Mayne Pharma International Pty Ltd

07/29/2013 Unknown

382 ERYGEL Topical Gel 2% Mylan Pharmaceuticals, Inc.

07/2015 Unknown

383 ERYPED Granule 200 mg per 5 mL when reconstituted

Arbor Pharmaceuticals LLC

09/2016 Unknown

384 EVISTA Tablets 60 mg Eli Lilly and Company

03/01/2014 Unknown

385 EXALGO Extended-release Tablets

8 mg Mallinckrodt Pharmaceuticals

06/12/2014 Unknown


12 mg Mallinckrodt Inc. 06/12/2014 Unknown


16 mg Mallinckrodt Inc. 06/12/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 388 EXALGO Extended-

release Tablets 32 mg Mallinckrodt Inc. 06/12/2014 Unknown

389 EXELON Capsule 1.5 mg Novartis Pharmaceuticals Corp.

07/1/2010 Unknown

390 EXELON Capsule 3 mg Novartis Pharmaceuticals Corp.

07/1/2010 Unknown

391 EXELON Capsule 4.5 mg Novartis Pharmaceuticals Corp.

07/1/2010 Unknown

392 EXELON Capsule 6 mg Novartis Pharmaceuticals Corp.

07/1/2010 Unknown

393 EXFORGE Tablets 10 mg/320 mg Novartis Pharmaceutical Corp.

03/2015 Unknown


03/2015 Unknown


03/2015 Unknown


03/2015 Unknown

397 EXFORGE HCT Tablets 5 mg/160 mg/12.5 mg (each tablet contains 6.9 mg amlodipine besylate)

Novartis Pharmaceutical Corporation

12/02/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 398 EXFORGE HCT Tablets 10 mg/160 mg/25 mg

(each tablet contains 13.9 mg amlodipine besylate)


12/02/2014 Unknown

399 EXFORGE HCT Tablets 5 mg/160 mg/25 mg (each tablet contains 6.9 mg amlodipine besylate)


12/02/2014 Unknown

400 EXFORGE HCT Tablets 10 mg/160 mg/12.5 mg (each tablet contains 13.9 mg amlodipine besylate)


12/02/2014 Unknown

401 EXFORGE HCT Tablets 10 mg/320 mg/25 mg (each tablet contains 13.9 mg amlodipine besylate)


12/02/2014 Unknown

402 FAMVIR Tablets 125 mg Novartis 03/22/2011 Unknown 403 FAMVIR Tablets 250 mg Novartis 03/22/2011 Unknown 404 FAMVIR FAMVIR Tablets 500 mg Novartis 03/22/2011 Unknown 405 FAZACLO Orally

Disintegrating Tablets

100 mg Jazz Pharmaceuticals 8/30/2012 Unknown

406 FAZACLO Orally Disintegrating Tablets

12.5 mg Jazz Pharmaceuticals 8/30/2012 Unknown

407 FAZACLO Orally Disintegrating Tablets

25 mg Jazz Pharmaceuticals 8/30/2012 Unknown

408 FELBATOL Oral 600 mg/5 mL Meda 1/2012 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Suspension Pharmaceuticals

409 FELBATOL Tablets 600 mg Meda Pharmaceuticals

11/2011 Unknown

410 FELBATOL Tablets 400 mg Meda Pharmaceuticals

11/2011 Unknown

411 FELDENE Capsules 10 mg Pfizer Inc. 03/03/2014 Unknown 412 FELDENE Capsules 20 mg Pfizer Inc. 03/03/2014 Unknown 413 FEMCON Fe Chewable

Tablets 0.4 mg/35 mcg Allergan

Pharmaceuticals International Ltd.

10/2011 Unknown

414 FENOGLIDE Tablets 40 mg Santarus, Inc. 06/24/2015 Unknown 415 FENOGLIDE Tablets 120 mg Santarus, Inc. 06/24/2015 Unknown 416 FIBRICOR Tablets 105 mg Aralez

Pharmaceuticals US, Inc.

09/22/2010 Unknown

417 FIBRICOR Tablets 35 mg Aralez Pharmaceuticals US, Inc.

09/22/2010 Unknown

418 FIORICET with CODEINE

Capsules 50 mg / 325 mg / 40 mg / 30 mg

Actavis Laboratories UT, Inc.

10/01/2003 Unknown

419 FIORINAL Capsules 50 mg / 325 mg / 40 mg Allergan Sales, LLC 10/6/2003 Unknown 420 FIORINAL with

CODEINE Capsules 50 mg / 325 mg / 40 mg /

30 mg Allergan Sales, LLC 10/26/2006 Unknown

421 FLORONE Cream 0.05% Pharmacia and Prior to 1/1/1999 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Upjohn Company

422 FLUMADINE Tablets 100 mg Forest Laboratories, Inc.

09/2002 - 09/2003 Unknown

423 FLUOXETINE Tablets 60 mg Alvogen Group Holdings 3, LLC

09/2017 Unknown

424 FML Ophthalmic Suspension

0.1% Allergan, Inc. 10/1997 Unknown

425 FOCALIN XR Extended-release Capsules

15 mg Novartis Pharmaceuticals Corporation

03/04/2014 Unknown



11/12/2014 Unknown



02/03/2015 Unknown



03/04/2014 Unknown



03/04/2014 Unknown

430 FORTESA Gel 10 mg testosterone/actuation

Endo Pharmaceuticals, Inc.

08/25/2014 Unknown

431 FURADANTIN Oral 25 mg / 5 mL Casper Pharma LLC 12/2011 - 12/2012 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Suspension

432 GABITRIL Tablets 4 mg Cephaloln, Inc. 12/26/2012 Unknown 433 GABITRIL Tablets 2 mg Cephalon, Inc 12/26/2012 Unknown 434 GASTROCROM Oral

Concentrate 100 mg/5 mL (ampule) Wallace

Pharmaceuticals Inc. 06/2015 Unknown

435 GENERESS FE Chewable Tablets

0.8 mg/25 mcg Allergan Pharmaceuticals International Ltd.

03/2015 Unknown

436 GEODON Capsules 40 mg Pfizer 12/15/2011 Unknown 437 GEODON Capsules 80 mg Pfizer 12/15/2011 Unknown 438 GEODON Capsules 60 mg Pfizer 12/15/2011 Unknown 439 GEODON Capsules 20 mg Pfizer 12/15/2011 Unknown 440 GLUCOTROL XL Extended-

release Tablets 2.5 mg Pfizer Inc. 03/11/2004 Unknown

441 GLUCOTROL XL Extended-release Tablets

5 mg Pfizer Inc. 03/11/2004 Unknown

442 GLUCOTROL XL Extended-release Tablets

10 mg Pfizer Inc. 03/11/2004 Unknown

443 GOLYTELY Powder for Oral Solution

PEG-3350 17.6 mmol/L, sodium 125 mmol/L, sulfate 40 mmol/L, chloride 35 mmol/L, bicarbonate 20 mmol/L and potassium 10 mmol/L

Braintree Laboratories, Inc.

07/2009 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing (per 4 liter jug w/water)

444 GRIS-PEG Tablets 125 mg Valeant Pharmaceuticals International Inc.

12/03/2012 Unknown

445 GRIS-PEG Tablets 250 mg Valeant Pharmaceuticals International Inc.

12/03/2012 Unknown

446 HALCION Tablets 0.25 mg Pharmacia and Upjohn Company

6/17/2003 Unknown

447 HALCION Tablets 0.125 mg Pharmacia and Upjohn Company

7/11/2003 Unknown

448 HALDOL Injection 5 mg/mL Janssen Pharmaceuticals, Inc.

7/2011 Unknown

449 HALDOL DECANOATE

Injection 50 mg/mL Janssen Research & Development, LLC

08/2011 Unknown

450 HALDOL DECANOATE

Injection 100 mg/mL Janssen Research & Development, LLC

07/2011 Unknown

451 HECTOROL Capsules, liquid filled

2.5 mcg Genzyme Corporation

03/11/2014 Unknown


1 mcg Genzyme Corporation

03/11/2014 Unknown


0.5 mcg Genzyme Corporation

03/11/2014 Unknown

454 HIPREX Tablets 1 g Validus Pharmaceuticals LLC

06/2016 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 455 IMITREX Injection 4 mg/0.5 mL (Kit) GlaxoSmithKline

Intellectual Property Ltd. England

03/29/2012 Unknown

456 IMITREX Injection 4 mg/0.5 mL GlaxoSmithKline Intellectual Property Ltd. England

3/29/2012 Unknown

457 IMITREX Injection 6 mg/0.5 mL Statdose kit GlaxoSmithKline Intellectual Property Ltd. England

03/29/2012 Unknown

458 IMITREX Injection 6 mg/0.5 mL (Kit) GlaxoSmithKline Intellectual Property Ltd. England

11/2007 - 11/2008 Unknown

459 IMITREX Injection 6 mg/0.5 mL GlaxoSmithKline Intellectual Property Ltd. England

11/2007 - 11/2008 Unknown

460 IMITREX Nasal Spray 5 mg GlaxoSmithKline Intellectual Property Ltd. England

10/13/2008 Unknown

461 IMITREX Nasal Spray 20 mg GlaxoSmithKline Intellectual Property Ltd. England

10/03/2008 Unknown

462 INDERAL LA Extended-release Capsules

60 mg ANI Pharmaceuticals, Inc.

2/25/2009 Unknown

463 INDERAL LA Extended- 80 mg ANI Pharmaceuticals, 2/25/2009 Unknown



Entered the Market

Date Authorized

Generic Ceased


Inc.



2/25/2009 Unknown



2/25/2009 Unknown

466 INSPRA Tablets 25 mg GD Searle LLC 09/13/2007 Unknown 467 INSPRA Tablets 50 mg GD Searle LLC 09/13/2007 Unknown 468 INVEGA Extended-

release Tablets 6 mg Janssen Research &


469 INVEGA Extended-release Tablets

1.5 mg Janssen Research & Development, LLC

09/24/2015 Unknown


3 mg Janssen Research & Development, LLC

09/24/2015 Unknown



09/24/2015 Unknown

472 IOPIDINE Ophthalmic Solution

0.5% Alcon Research, Ltd. 08/2009 Unknown

473 ISOPTO CARPINE Ophthalmic Solution

4% Novartis Pharmaceuticals Corporation

02/21/1996 Unknown


1% Novartis Pharmaceuticals

02/21/1996 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Corporation


2% Novartis Pharmaceuticals Corporation

02/21/1996 Unknown

476 JALYN Capsules 0.5 mg/0.4 mg GlaxoSmithKline LLC

07/2016 Unknown

477 KADIAN Extended-release Capsules

30 mg Allergan Sales, LLC 7/2012 - 7/2013 Unknown











483 KADIAN Extended- 80 mg Allergan Sales, LLC 11/11/2011 Unknown



Entered the Market

Date Authorized

Generic Ceased





20 mg Allergan Sales, LLC. 11/11/2011 Unknown











491 KAPVAY Extended-release Tablets

0.1 mg Concordia Pharmaceuticals, Inc.

06/2016 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 492 KAZANO Tablets 12.5 mg/1000 mg Takeda U.S.A. Inc. 04/2016 Unknown 493 KAZANO Tablets 12.5 mg/500 mg Takeda U.S.A. Inc. 04/2016 Unknown 494 K-DUR 10 Extended-

release Tablets 10 mEq Schering Corporation 06/2002 - 06/2003 Unknown

495 K-DUR 20 Extended-release Tablets

20 mEq Schering Corporation 06/1998 - 06/1999 Unknown

496 KEFLEX Capsules 750 mg Pragma Pharmaceuticals, LLC

06/2017 Unknown

497 KHEDEZLA Extended-release Tablets

50 mg Osmotica Pharmaceutical Corporation

07/10/2013 Unknown

498 KHEDEZLA Extended-release Tablets

100 mg Osmotica Pharmaceutical US LLC

07/10/2013 Unknown

499 KLARON Lotion 10% Valeant Pharmaceuticals North America, LLC

12/2005 - 12/2006 Unknown

500 K-TAB Extended-release Tablets

750 mg AbbVie Inc. 02/2011 Unknown





503 LAC-HYDRIN Cream eq. 12% base Bristol-Myers Squibb 07/2004 - 06/2005 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Company

504 LAC-HYDRIN Lotion eq. 12% base Bristol-Myers Squibb Company

03/2004 - 02/2005 Unknown

505 LANOXIN Tablets 0.25 mg Concordia Pharmaceuticals Inc.

01/14/2014 Unknown

506 LANOXIN Tablets 0.125 mg Concordia Pharmaceuticals Inc.

01/14/2014 Unknown

507 LESCOL XL Extended-release Tablets


10/15/2015 Unknown

508 LEVO-T Tablets 150 mcg ALARA Pharmaceutical Corporation

03/2002 Unknown


03/2002 Unknown


03/2002 Unknown


03/2002 Unknown


03/2002 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 513 LEVO-T Tablets 88 mcg ALARA

Pharmaceutical Corporation

03/2002 Unknown


03/2002 0781-5181-10


03/2002 Unknown


03/2002 Unknown


03/2002 Unknown


03/2002 Unknown


03/2002 Unknown

520 LEXAPRO Oral Solution 5 mg / 5 mL Allergan Sales, LLC 03/26/2015 Unknown 521 LEXAPRO Tablets 5 mg Forest

Laboratories,LLC 2/29/2012 Unknown

522 LEXAPRO Tablets 20 mg Forest Laboratories, 2/29/2012 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing LLC

523 LEXAPRO Tablets 10 mg Forest Laboratories, LLC

2/29/2012 Unknown

524 LIBRAX Capsules 5 mg/2.5 mg Valeant Pharmaceuticals North America LLC

09/23/2009 Unknown

525 LIBRAX Capsules 5 mg/2.5 mg Valeant Pharmaceuticals North America LLC

09/2016 - 08/2017 Unknown

526 LIDEX Topical Solution

0.05% County Line Pharmaceuticals, LLC

04/01/2014 - 03/31/2015 Unknown

527 LIDODERM Film, Controlled Release

5% (700 mg per patch) Teikoku Pharma USA, Inc.

05/02/2016 Unknown

528 LIDODERM Patch 700 mg (50 mg per gram adhesive) in an aqueous base

Teikoku Pharma USA, Inc.

05/2014 Unknown

529 LIMBITROL Tablets 5 mg; eq. 12.5 mg base Valeant Pharmaceuticals International

01/2006 - 12/2006 Unknown

530 LIMBITROL DS Tablets 10 mg; eq. 25 mg base Valeant Pharmaceuticals International

01/2007 - 12/2007 Unknown

531 LIORESAL Injection 0.5 mg/mL Medtronic Inc 06/1999 - 05/2000 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 532 LIORESAL Injection 2 mg/mL Medtronic Inc 06/1999 - 05/2000 Unknown 533 LIPITOR Tablets 40 mg Pfizer 1/28/2013 Unknown 534 LIPITOR Tablets 20 mg Pfizer 1/28/2013 Unknown 535 LIPITOR Tablets 80 mg Pfizer 1/28/2013 Unknown 536 LIPITOR Tablets 10 mg Pfizer 1/28/2013 Unknown 537 LIPOFEN Capsules 50 mg Cipher

Pharmaceuticals, Inc. 04/2016 Unknown

538 LIPOFEN Capsules 150 mg Cipher Pharmaceuticals, Inc.

04/2016 Unknown

539 LITHOBID Extended-release Tablets


12/2016 Unknown

540 LOCOID Cream 0.1% Precision Dermatology, Inc.

09/2009 Unknown

541 LOCOID Cream 0.1% Precision Dermatology, Inc.

07/2013 Unknown

542 LOCOID (Ointment) Ointment 0.1% Precision Dermatology, Inc.

10/2013 - 10/2014 Unknown

543 LOCOID (Ointment) Ointment 0.1% Precision Dermatology, Inc.

10/2015 - 10/2016 Unknown

544 LOCOID (Solution) Topical Solution

0.1% Precision Dermatology, Inc.

02/1987 Unknown

545 LOCOID (Solution) Topical Solution

0.1% Precision Dermatology, Inc.

02/24/2010 Unknown

546 LOCOID Cream 0.1% Precision 07/03/2013 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing LIPOCREAM Dermatology, Inc.

547 LOCOID LIPOCREAM

Cream 0.1% Precision Dermatology, Inc

08/22/2013 Unknown

548 LODOSYN Tablets 25 mg Aton Pharma, Inc. 04/2014 Unknown 549 LOESTRIN 2 Fe Tablets 1 mg/20 mcg Allergan

Pharmaceuticals International Ltd.

11/05/2015 Unknown

550 LOMOTIL Tablet 2.5 mg/0.025 mg GD Searle 07/2011, 02/2013 Unknown 551 LOPRESSOR HCT Tablets 1 mg/mL Novartis

Pharmaceuticals Corporation

03/1998 - 03/1999 Unknown

552 LOPRESSOR HCT Tablets 50mg / 25mg Novartis Pharmaceuticals Corporation

11/25/2009 Unknown

553 LOPRESSOR HCT Tablets 100 mg / 25 mg Novartis Pharmaceuticals Corporation

11/25/2009 Unknown

554 LOPROX Cream 0.77% Medicis Pharmaceutical Corporation

12/2004 - 11/2005 Unknown

555 LOPROX Gel 0.77% County Line Pharmaceuticals, LLC

07/2007 - 06/2008 Unknown

556 LOPROX Shampoo 1% Medicis Pharmaceutical

12/2012 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Corporation

557 LOPROX Topical Suspension

0.77% Medicis Pharmaceutical Corporation

12/2003 - 11/2004 Unknown

558 LoSEASONIQUE Tablets 0.1 mg/0.02 mg and 0.01 mg

Teva Branded Pharmaceutical Products

12/07/2010 Unknown

559 LOTENSIN HCT Tablets 10 mg; 12.5 mg Validus Pharmaceuticals LLC

06/2013 - 05/2014 Unknown

560 LOTENSIN HCT Tablets 20 mg; 25 mg Validus Pharmaceuticals LLC

06/2013 - 05/2014 Unknown

561 LOTENSIN HCT Tablets 20 mg; 12.5 mg Validus Pharmaceuticals LLC

06/2013 - 05/2014 Unknown

562 LOTORNEX Tablets 0.5 mg Sebela Ireland Limited

05/2015 Unknown

563 LOTREL Capsules 2.5 mg; 10 mg Novartis Pharmaceuticals Corporation

06/11/2007 Unknown

564 LOTREL Capsules 5 mg; 10 mg Novartis Pharmaceuticals Corporation

06/11/2007 Unknown


06/11/2007 Unknown

566 LOTREL Capsules 10 mg; 20 mg Novartis 06/11/2007 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Pharmaceuticals Corporation


01/03/2011 Unknown


01/03/2011 Unknown

569 LOTRIMIN AF Cream 1% Schering-Plough HealthCare Products, Inc

03/1998 - 03/1999 Unknown

570 LOTRISONE Cream 1%/0.05% Merck Sharp & Dohme Corporation

8/16/2012 Unknown

571 LOTRONEX Tablets 1 mg Sebela Ireland Limited

05/2015 Unknown

572 LOVAZA Capsules 1 gram GlaxoSmithKline LLC

03/05/2015 Unknown

573 LOVENOX Injection 120 mg prefilled syringe Sanofi Aventis US LLC

05/2015 Unknown

574 LOVENOX Injection 120 mg/0.8 mL Sanofi Aventis US LLC

10/2011 Unknown


03/2015 Unknown


05/2015 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 577 LOVENOX Injection 30 mg prefilled syringe Sanofi Aventis US

LLC 03/2015 Unknown


03/2015 Unknown


03/2015 Unknown


03/2015 Unknown

581 LOVENOX Injection 300 mg/3mL Sanofi Aventis US LLC

10/2011 Unknown


03/2015 Unknown

583 LOVENOX Injection 150 mg/1 mL Sanofi Aventis US LLC

10/2011 Unknown

584 LOVENOX Injection 100 mg/1 mL Sanofi Aventis US LLC

10/2011 Unknown


10/2011 Unknown


10/2011 Unknown


10/2011 Unknown


10/2011 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 589 LOZOL Tablets 2.5 mg Rhone-Poulenc Rorer

Pharmaceuticals Inc. Prior to 1/1/1999 Unknown

590 LUVOX Tablets 25 mg ANI Pharmaceuticals, Inc.

08/09/2011 Unknown


08/09/2011 Unknown


08/09/2011 Unknown

593 LYSTEDA Tablets 650 mg Ferring Pharmaceuticals Inc.

03/17/2016 Unknown

594 LYSTEDA Tablets 650 mg Ferring Pharmaceuticals Inc.

01/03/2013 Unknown

595 MACROBID Capsules 100 mg Alvogen PB Research and Development, LLC

02/2011 Unknown

596 MACROBID Capsules 100 mg Alvogen PB Research and Development, LLC

02/2011 Unknown

597 MACRODANTIN Capsules 50 mg Alvogen PB Research and Development, LLC

08/2011 Unknown


08/2011 Unknown

599 MACRODANTIN Capsules 100 mg Alvogen PB Research 08/2011 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing and Development, LLC


08/2011 Unknown

601 MALARONE Tablets 250 mg/100 mg GlaxoSmithKline LLC

7/31/2012 Unknown

602 MARINOL Capsules 10 mg AbbVie 05/2008 - 05/2009 Unknown 603 MARINOL Capsules 5 mg AbbVie 05/2008 - 05/2009 Unknown 604 MARINOL Capsules 2.5 mg AbbVie 05/2008 - 05/2009 Unknown 605 MAXITROL Ophthalmic

Ointment 3.5 mg, 10000 units, 0.1% / gram

Alcon Laboratories, Inc.

03/04/1996 Unknown

606 MAXZIDE Tablets 75 mg and 50 mg Mylan Pharmaceuticals Inc.


607 MAXZIDE-25 Tablets 37.5 mg and 25 mg Mylan Pharmaceuticals Inc.


608 MEDROL Tablets 4 mg Pharmacia and Upjohn

11/16/2011 Unknown


4/22/2013 Unknown


4/22/2013 Unknown


4/22/2013 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 612 MEPRON Suspension 750 mg/5mL GlaxoSmithKline


613 MESNEX Injection 100 mg/mL Baxter Healthcare Corporation

12/2003 - 12/2004 Unknown

614 MESTINON Tablets 60 mg Valeant Pharmaceuticals North America, LLC

04/2002 - 03/2003 Unknown

615 MESTINON TIMESPAN

Tablets 180 mg Valeant Pharmaceuticals North America, LLC

11/2015 Unknown

616 METADATE CD Extended-release Capsules

30 mg UCB, Inc. 09/2012 Unknown











Entered the Market

Date Authorized

Generic Ceased

Marketing 621 METADATE CD Extended-

release Capsules


622 METHYLIN Oral Solution 10 mg/5 mL Mallinckrodt Inc. 08/01/2013 Unknown 623 METHYLIN Oral Solution 5 mg/5 mL Mallinckrodt Inc. 08/01/2013 Unknown 624 METROCREAM Cream 0.75% Galderma

Laboratories, L.P. 03/2015 Unknown

625 METROCREAM Cream 0.75% Galderma Laboratories, L.P.

3/2009 Unknown

626 METROGEL Gel 0.75% Galderma Laboratories, L.P.

03/2014 Unknown

627 METROGEL Gel 0.75% Galderma Laboratories, L.P.

03/2014 Unknown

628 METROGEL Gel 1% Galderma Laboratories, L.P.

06/2005 Unknown

629 METROGEL Gel 1% Galderma Laboratories, L.P.

02/2017 Unknown

630 METROGEL-VAGINAL

Vaginal Gel 0.75% Medicis Pharmaceuticals, a Div. Of Valeant Pharmaceuticals North America LLC

04/01/2015 Unknown

631 METROLOTION Lotion 0.75% Galderma Laboratories, L.P.

6/16/2009 Unknown

632 MIACALCIN Nasal Spray 200 I.U. per actuation Sebela Ireland Ltd. 12/09/2008 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 633 MICARDIS Tablets 40 mg Boehringer Ingelheim

Pharmaceuticals, Inc. 11/13/2013 Unknown

634 MICARDIS Tablets 20 mg Boehringer Ingelheim Pharmaceuticals, Inc.

11/13/2013 Unknown

635 MICARDIS Tablets 80 mg Boehringer Ingelheim Pharmaceuticals, Inc.

11/13/2013 Unknown

636 MICARDIS HCT Tablets 40 mg/12.5 mg Boehringer Ingelheim Pharmaceuticals, Inc.

02/28/2014 Unknown

637 MICARDIS HCT Tablets 80 mg/12.5 mg Boehringer Ingelheim Pharmaceuticals, Inc.

02/28/2014 Unknown

638 MICARDIS HCT Tablets 80 mg/25 mg Boehringer Ingelheim Pharmaceuticals, Inc.

02/28/2014 Unknown

639 MICRO-K EXTENCAPS

Extended-Release Capsules

8 mEq (600 mg) Nesher Pharmaceuticals USA LLC

03/10/2011 Unknown

640 MICRO-K EXTENCAPS

Extended-Release Capsules

10 mEq (750 mg) Nesher Pharmaceuticals USA LLC

01/19/2011 Unknown

641 MICRONASE Tablets 2.5 mg Pharmacia and Upjohn


642 MICRONASE Tablets 5 mg Pharmacia and Upjohn


643 MICROZIDE Capsules 12.5 mg Allergan Sales, LLC 10/05/2001 Unknown 644 MIDAMOR Tablets 5 mg Paddock Laboratories 04/06/2009 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 645 MIGRANAL Nasal Spray 4 mg in 1 mL Valeant


03/18/2013 Unknown

646 MINIPRESS Capsules 1 mg Pfizer Inc. 01/2017 Unknown 647 MINIPRESS Capsules 2 mg Pfizer Inc. 01/2017 Unknown 648 MINIPRESS Capsules 5 mg Pfizer Inc. 01/2017 Unknown 649 MITIGARE Capsules 0.6 mg Hikma International

Pharmaceuticals LLC 10/01/2014 Unknown

650 MOBIC Oral Suspension

7.5 mg/5 mL Boehringer Ingelheim Pharmaceuticals Inc.

6/12/2006 Unknown

651 MONODOX Capsules eq. 50 mg base Watson Laboratories, Inc.

02/07/2005 Unknown

652 MONODOX Capsules eq. 100 mg base Watson Laboratories, Inc.

02/07/2005 Unknown

653 MONOKET Tablets 10 mg Kremers Urban Pharmaceuticals, Inc.

06/30/1996 - 06/29/1997 Unknown

654 MONOKET Tablets 20 mg Kremers Urban Pharmaceuticals, Inc.

06/30/1996 - 06/29/1997 Unknown

655 MOXATAG Extended-Release Tablets

775 mg Vernalis (R&D) Limited

08/20/2014 Unknown

656 MS CONTIN Extended-release Tablets

15 mg Purdue Pharma L.P. 05/2005 - 05/2006 Unknown

657 MS CONTIN Extended- 30 mg Purdue Pharma L.P. 05/2005 - 05/2006 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing release Tablets







661 MYAMBUTOL Tablets 100 mg STI Pharma LLC 12/15/2006 Unknown 662 MYAMBUTOL Tablets 400 mg STI Pharma LLC 12/15/2006 Unknown 663 MYCOBUTIN Capsules 150 mg Pharmacia and


664 NAFTIN CREAM Cream emulsion

1% Merz Pharmaceuticals, LLC

06/01/2015 Unknown

665 NAFTIN CREAM Cream emulsion

2% Merz Pharmaceuticals, LLC

06/01/2015 Unknown

666 NALFON Capsules 400 mg Xsprire Pharma 08/05/2015 Unknown 667 NAMENDA Tablets 5 mg Forest Laboratories,


668 NAMENDA Tablets 10 mg Forest Laboratories, LLC

04/01/2015 Unknown

669 NAMENDA Tablets 5 mg and 10 mg (titration pak)

Forest Laboratories, LLC

04/01/2015 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 670 NAPRELAN Controlled-

Release Tablets

500 mg Alvogen PB Research and Development LLC

03/2015 Unknown

671 NAPRELAN Controlled-Release Tablets

375 mg Alvogen PB Research and Development LLC

09/2015 Unknown

672 NARDIL Tablet 15 mg Parke-Davis 3/23/2011 Unknown 673 NASACORT AQ Nasal Spray

Spray Bottle 55 mcg/spray Sanofi Aventis US,


674 NASONEX Suspension 50 mcg Merck Sharp & Dohme Corporation

03/25/2016 Unknown

675 NATROBA Topical Suspension

0.9% ParaPRO LLC 06/2014 Unknown

676 NEOPROFEN Injection 10 mg/mL Recordati Rare Diseases Inc.

04/2016 Unknown

677 NESINA Tablets 25 mg Takeda U.S.A. Inc. 04/2016 Unknown 678 NESINA Tablets 12.5 mg Takeda U.S.A. Inc. 04/2016 Unknown 679 NESINA Tablets 6.25 mg Takeda U.S.A. Inc. 04/2016 Unknown 680 NEURONTIN Capsules 100 mg Pfizer Inc. 3/17/2004 Unknown 681 NEURONTIN Capsules 300 mg Pfizer Inc. 03/17/2004, 06/19/2009 Unknown 682 NEURONTIN Capsules 400 mg Pfizer Inc. 3/17/2004 Unknown 683 NEURONTIN Oral Solution 250 mg per 5 mL Pfizer Inc. 3/24/2011 Unknown 684 NEURONTIN Tablets 600 mg Pfizer Inc. 3/17/2004 Unknown 685 NEURONTIN Tablets 800 mg Pfizer Inc. 3/17/2004 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 686 NIASPAN Extended-

release Tablets 750 mg AbbVie 06/30/2014 Unknown

687 NIASPAN Extended-release Tablets

500 mg AbbVie 06/30/2014 Unknown

688 NIASPAN Extended-release Tablets

1000 mg AbbVie 06/30/2014 Unknown

689 NICORETTE Chewing Gum 2 mg GlaxoSmithKline Consumer Healthcare L.P.

01/2002 - 01/2003 Unknown

690 NICORETTE Chewing Gum 4 mg GlaxoSmithKline Consumer Healthcare L.P.

06/2001 - 06/2002 Unknown

691 NITROLINGUAL PUMPSPRAY

Lingual Spray 400 mcg per Spray G. Pohl-Boskamp GmbH & Co. Arbor Pharmaceuticals

02/01/2011 Unknown

692 NITROMIST Lingual Aerosol

400 mcg/spray Mist Pharmaceuticals, LLC

10/16/2012 Unknown

693 NITROSTAT Tablets 0.6 mg Pfizer Pharmaceuticals Ltd.

08/26/2016 Unknown


08/26/2016 Unknown


08/26/2016 Unknown

696 NIZORAL Shampoo 2% Janssen Research & Development, LLC

08/10/2005 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 697 NORFLEX Extended-

release Tablets 100 mg 3M Pharmaceuticals Prior to 1/1/1999 Unknown

698 NORINYL Tablets 1.0 mg / 0.05 mg Actavis Laboratories UT, Inc.

02/22/2007 Unknown

699 NORPRAMIN Tablets 10 mg Sanofi-Aventis US LLC

04/2014 Unknown


04/2014 Unknown


04/2014 Unknown




04/2014 Unknown


04/2014 Unknown

705 NOR-QD Tablets 0.35 mg Actavis Laboratories UT, Inc.

06/06/2003 Unknown

706 NORVASC Tablets 2.5 mg Pfizer Inc. 4/16/2007; 6/15/2006 Unknown 707 NORVASC Tablets 5 mg Pfizer Inc. 4/16/2007; 6/15/2006 Unknown 708 NORVASC Tablets 10 mg Pfizer Inc. 4/16/2007; 6/15/2006 Unknown 709 NULYTELY Powder (for

reconstitution with water)

Per 4 liter jug: polyethylene glycol 3350 420 g, sodium bicarbonate

Braintree Laboratories, Inc.Y

02/2013 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 5.72 g, sodium chloride 11.2 g, potassium chloride 1.48 g, flavoring 2 g

710 OCUFEN Ophthalmic Solution

0.03 % Allergan, Inc 05/2007 Unknown

711 OLUX Foam 0.05% Mylan Pharmaceuticals Inc.

02/2014 Unknown

712 OLUX-E Emulsion, Aerosol Foam

0.05% Mylan Pharmaceuticals Inc.

01/2014 Unknown

713 OMNIPRED Ophthalmic Suspension

1% Alcon Pharmaceuticals Ltd. / Alcon Research Ltd.

01/1995 Unknown

714 OPANA Tablets 5 mg Endo Pharmaceuticals, Inc.

09/29/2010 Unknown

715 OPANA Tablets 10 mg Endo Pharmaceuticals, Inc.

09/29/2010 Unknown

716 OPTIVAR Ophthalmic Solution

0.05% Meda Pharmaceuticals, Inc.

03/10/2011 Unknown

717 ORACEA Capsules 40 mg Galderma Laboratories, L.P.

04/2015 Unknown

718 ORAPRED ODT Orally Disintegrating Tablets

10 mg Concordia Pharmaceuticals Inc.

10/2015 Unknown

719 ORAPRED ODT Orally Disintegrating


10/2015 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Tablets

720 ORAPRED ODT Orally Disintegrating Tablets


10/2015 Unknown

721 ORTHO CYCLEN-28 Tablets 0.25/0.035 mg Janssen Research & Development, LLC

01/2003 Unknown

722 ORTHO MICRONOR Tablets 0.35 mg Janssen Research and Development LLC

06/2003 Unknown

723 ORTHO TRI-CYCLEN

Tablets 0.180/0.035 mg; 0.215/0.035 mg; 0.250/0.035 mg

Janssen Research and Development, LLC

9/2003 Unknown

724 ORTHO TRI-CYCLEN LO

Tablets 0.180/0.025 mg; 0.215/0.025 mg; 0.250/0.025 mg

Janssen Research and Development, LLC

01/04/2016 Unknown

725 ORTHO-NOVUM 7/7/7

Tablets 0.5 mg and 0.035 mg Janssen Research & Development, LLC

11/11/2002 Unknown

726 OSENI Tablets 25 mg/15 mg Takeda U.S.A. Inc. 04/2016 Unknown 727 OSENI Tablets 12.5 mg/15 mg Takeda U.S.A. Inc. 04/2016 Unknown 728 OSENI Tablets 25 mg/45 mg Takeda U.S.A. Inc. 04/2016 Unknown 729 OSENI Tablets 25 mg/30 mg Takeda U.S.A. Inc. 04/2016 Unknown 730 OSENI Tablets 12.5 mg/30 mg Takeda U.S.A. Inc. 04/2016 Unknown 731 OSENI Tablets 12.5 mg/45 mg Takeda U.S.A. Inc. 04/2016 Unknown 732 OVIDE Lotion 0.5% Taro Pharmaceuticals

USA, Inc. 08/02/2008 - 08/01/2009 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 733 OXANDRIN Tablets 2.5 mg Savient

Pharmaceuticals, Inc. 06/2006 - 05/2007 Unknown

734 OXANDRIN Tablets 10 mg Savient Pharmaceuticals, Inc.

06/2006 - 05/2007 Unknown

735 OXSORALEN ULTRA

Capsule 10 mg Dow Pharmaceutical Sciences

07/15/2014 Unknown

736 OXYCODONE HYDROCHLORIDE

Capsules 5 mg Genus Lifesciences, Inc.

12/15/2010 Unknown

737 OXYCODONE HYDROCHLORIDE

Oral Solution 100 mg/5 mL Genus Lifesciences, Inc.

12/20/2010 Unknown

738 OXYCONTIN Extended-release Tablets

15 mg Purdue Pharma 03/2016 Unknown


80 mg Purdue Pharma 08/14/2014 Unknown













Entered the Market

Date Authorized

Generic Ceased

Marketing 745 OXYCONTIN Extended-

release Tablets 10 mg Purdue Pharma 10/08/2014 Unknown

























Entered the Market

Date Authorized

Generic Ceased

Marketing 757 OXYCONTIN Extended-

release Tablets 80 mg Purdue Pharma 09/22/2014 Unknown







761 PARAPLATIN for Injection 50 mg/vial Bristol-Myers Squibb Company

03/2004 - 02/2005 Unknown


03/2004 - 02/2005 Unknown


03/2004 - 02/2005 Unknown

764 PARAPLATIN AQ Injection eq. 50 mg/5 mL (10 mg/mL)

Bristol-Myers Squibb Company

07/2004 - 06/2005 Unknown



07/2004 - 06/2005 Unknown



07/2004 - 06/2005 Unknown



07/2004 - 06/2005 Unknown

768 PARLODEL Capsules 5 mg Validus Pharmaceuticals LLC

12/1998, 4/2006 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 769 PARLODEL Tablets 2.5 mg Validus

Pharmaceuticals LLC Prior to 1/1/1999 Unknown

770 PARNATE Tablets 10 mg Concordia Pharmaceuticals Inc.

02/05/2016 Unknown

771 PATADAY Ophthalmic Solution


06/2017 Unknown

772 PATANASE Nasal Spray 665 mcg in 100 mg solution

Novartis Pharmaceuticals Corporation

04/2015 Unknown

773 PATANASE Nasal Spray 665 mcg in 100 mg solution

Novartis Pharmaceuticals Corporation

04/2015 Unknown

774 PATANOL Ophthalmic Solution


09/15/2015 Unknown

775 PAXIL CR Tablets 12.5 mg GlaxoSmithKline 10/21/2010 Unknown 776 PAXIL CR Tablets 25 mg GlaxoSmithKline 10/21/2010 Unknown 777 PAXIL CR Tablets 37.5 mg GlaxoSmithKline 10/21/2010 Unknown 778 PEDIAPRED Oral Solution eq. 5 mg base/5 mL UCB, Inc. 11 Feb 2002 Unknown 779 PHOSLO Gelcaps 667 mg Fresenius Medical

Care North America 03/2014 - 03/2015 Unknown

780 PLAN B ONE STEP Tablets 1.5 mg Teva Branded Pharmaceutical Products R&D, Inc.

02/12/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 781 PLAQUENIL Tablets 200 mg Concordia

Pharmaceuticals Inc. 05/1999 - 04/2000 Unknown

782 PLENDIL Extended-release Tablets

2.5 mg AstraZeneca LP 10/2008 Unknown


5 mg AstraZeneca LP 10/2008 Unknown



785 PLETAL Tablets 50 mg Otsuka Pharmaceutical Company, Ltd.

10/18/2004 Unknown

786 PLETAL Tablets 100 mg Otsuka Pharmaceutical Company, Ltd.

10/18/2004 Unknown

787 POLYTRIM Ophthalmic Solution

10 mL unit Allergan, Inc. 04/29/1997 Unknown

788 PONSTEL Capsules 250 mg Shionogi, Inc. 07/11/2011 Unknown 789 POTASSIUM

CHLORIDE FOR ORAL SOLUTION

Powder for Solution

20 mEq Pharma Research Software Solution, LLC

01/2017 Unknown

790 POTASSIUM CHLORIDE FOR ORAL SOLUTION

Powder for Solution

20 mEq Pharma Research Software Solution, LLC

09/2015 Unknown

791 POTASSIUM CHLORIDE ORAL

Oral Solution 20 mEq per 15 mL Lehigh Valley Technologies

05/14/2015 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing SOLUTION, USP, 10%

792 POTASSIUM CHLORIDE ORAL SOLUTION, USP, 10%


05/14/2015 Unknown

793 POTASSIUM CHLORIDE ORAL SOLUTION, USP, 20%


05/14/2015 Unknown

794 PRAVACHOL Tablets 10 mg Bristol-Myers Squibb Company

10/2005 - 09/2006 Unknown


10/2005 - 09/2006 Unknown


10/2005 - 09/2006 Unknown


10/2005 - 09/2006 Unknown

798 PRECOSE Tablets 50 mg Bayer Healthcare Pharmaceuticals, Inc.

01/30/2009 Unknown


01/30/2009 Unknown


01/30/2008 Unknown

801 PRED FORTE Ophthalmic Suspension

1% Allergan, Inc. 08/1997 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 802 PREVACID Delayed-

Release Capsules

15 mg Takeda Global Research & Development Center, Inc.

11/2009 Unknown

803 PREVACID Delayed-Release Capsules

30 mg Takeda Global Research & Development Center, Inc.

11/2009 Unknown

804 PREVPAC Delayed-Release Capsules, Capsules, and Tablets

30 mg, 500 mg, and 500 mg

Takeda Pharmaceuticals U.S.A., Inc.

03/02/2015 Unknown

805 PRILOSEC Delayed-release Capsules


806 PROCARDIA Capsules 10 mg Pfizer Inc. 3/25/2013 Unknown 807 PROCARDIA XL Extended-

release Tablets 30 mg Pfizer Inc. 3/31/10 and 4/29/10 Unknown

808 PROCARDIA XL Extended-release Tablets

60 mg Pfizer Inc. 3/31/10 and 4/29/10 Unknown

809 PROCARDIA XL Extended-release Tablets

90 mg Pfizer Inc. 3/31/10 and 4/29/10 Unknown

810 PROMETRIUM Capsules 200 mg Virtus Pharmaceuticals,

07/2016 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing LLC

811 PROMETRIUM Capsules 100 mg Virtus Pharmaceuticals, LLC

07/2016 Unknown


07/30/2010 Unknown


07/30/2010 Unknown

814 PROVERA Tablets 10 mg Pharmacia and Upjohn

6/18/2003 Unknown

815 PROVERA Tablets 2.5 mg Pharmacia and Upjohn

6/18/2003 Unknown

816 PROVERA Tablets 5 mg Pharmacia and Upjohn

6/18/2003 Unknown

817 PROVIGIL Tablets 100 mg Cephalon, Inc. 03/29/2012 Unknown 818 PROVIGIL Tablets 200 mg Cephalon Inc. 03/29/2012 Unknown 819 PURINETHOL Tablets 50 mg Stason

Pharmaceuticals Inc. 11/2016 Unknown

820 QUALAQUIN Capsules 324 mg Sun Pharmaceutical Industries, Inc.

07/23/2012 Unknown

821 QUEDEXY XR Extended-release Capsules

50 mg Upsher-Smith Pharmaceuticals

07/07/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 822 QUEDEXY XR Extended-

release Capsules


07/07/2014 Unknown



07/07/2014 Unknown



07/07/2014 Unknown



07/07/2014 Unknown

826 RAPAMUNE Tablets 1 mg PF Prism CV 10/27/2014 Unknown 827 RAPAMUNE Tablets 2 mg PF Prism CV 10/27/2014 Unknown 828 RAPAMUNE Tablets 0.5 mg PF Prism C.V. 01/16/2014 Unknown 829 RAZADYNE Tablets 4 mg Janssen Research and


830 RAZADYNE Tablets 8 mg Janssen Research and Development, LLC

08/28/2008 Unknown

831 RAZADYNE Tablets 12 mg Janssen Research and Development, LLC

08/28/2008 Unknown

832 RAZADYNE ER Capsules 8 mg Janssen Research and Development, LLC

10/13/2008 Unknown

833 RAZADYNE ER Capsules 16 mg Janssen Research and Development, LLC

10/13/2008 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 834 RAZADYNE ER Capsules 24 mg Janssen Research and


835 REGLAN Injection eq. 5 mg base/mL Baxter Healthcare Corporation

02/2003 - 02/2004 Unknown

836 REGLAN Tablets eq. 5 mg base A.H. Robins, Inc. 08 March 2010 Unknown 837 RELPAX Tablets 40 mg Pfizer Ireland

Pharmaceuticals 07/2017 Unknown

838 RELPAX Tablets 20 mg Pfizer Ireland Pharmaceuticals

07/2017 Unknown

839 REMERON SOLTAB Orally Disintegrating Tablets

15 mg Organon USA, Inc. 10/06/2004 Unknown





842 RENVELA Tablets 800 mg Genzyme Corporation

04/16/2014 Unknown

843 RESTORIL Capsules 22.5 mg Mallinckrodt Inc. 07/21/2008 Unknown 844 RESTORIL Capsules 7.5 mg Mallinckrodt Inc. 07/22/2008 Unknown 845 RETIN-A Cream 0.025% Valeant


09/2014 - 09/2015 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 846 RETIN-A Cream 0.05% Valeant


02/06/2014 Unknown

847 RETIN-A Cream 0.025% Valeant Pharmaceuticals North America, LLC

09/2014 - 09/2015 Unknown

848 RETIN-A Cream 0.1 % Valeant Pharmaceuticals North America, LLC

01/26/1973 Unknown


07/19/1974 Unknown


02/06/2014 Unknown

851 RETIN-A Cream 0.05% Valeant Pharmaceuticals North America, LLC Valeant Pharmaceuticals North America, LLC Valeant Pharmaceuticals North America, LLC

06/2005 Unknown

852 RETIN-A Gel 0.01 % Valeant Pharmaceuticals

02/06/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing North America, LLC

853 RETIN-A Gel 0.025% Valeant Pharmaceuticals North America, LLC

02/06/2014 Unknown

854 RETIN-A Gel 0.025% Valeant Pharmaceuticals North America, LLC

06/2005 Unknown

855 RETIN-A MICRO Gel 0.04% Valeant Pharmaceuticals North America, LLC

03/2013 Unknown


10/01/2014 Unknown


10/01/2014 Unknown

858 RETIN-A MICRO Gel 0.1 % Valeant Pharmaceuticals North America, LLC

03/2013 Unknown

859 REVATIO Tablets 20 mg Pfizer 11/6/2012 Unknown 860 RILUTEK Tablets 50 mg Covis Pharma B.V. 05/15/2013 Unknown 861 RISPERDAL Oral Solution 1 mg/mL Janssen Research &


862 RISPERDAL Tablets 0.25 mg Janssen Research & Development, LLC

06/30/2008 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 863 RISPERDAL Tablets 0.5 mg Janssen Research &


864 RISPERDAL Tablets 1 mg Janssen Research & Development, LLC

06/30/2008 Unknown


06/30/2008 Unknown


06/30/2008 Unknown


06/30/2008 Unknown

868 RISPERDAL M-TAB Orally Disintegrating Tablets

0.5 mg Janssen Research & Development, LLC

06/30/2008 Unknown



02/24/2009 Unknown



02/24/2009 Unknown



02/24/2009 Unknown



02/24/2009 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 873 RITALIN Tablet 10 mg Novartis

Pharmaceuticals Corp 6/8/2007 Unknown

874 RITALIN Tablet 5 mg Novartis Pharmaceuticals Corp

10/09/2007 Unknown

875 RITALIN Tablet 20 mg Novartis Pharamceuticals Corp

8/23/2007 Unknown

876 RITALIN SR Extended-release Tablets


03/09/2007 Unknown

877 ROBINUL Injection 0.2 mg/mL Eurohealth International Sarl

02/06/1975 Unknown

878 ROBINUL Tablets 1 mg Shionogi Pharma, Inc.

01/13/2005 Unknown

879 ROBINUL FORTE Tablets 2 mg Shionogi Pharma, Inc.

01/13/2005 Unknown

880 ROCALTROL Capsules 0.25 mcg Validus Pharmaceuticals LLC

08/26/2009 Unknown

881 ROCALTROL Capsules 0.5 mcg Validus Pharmaceuticals LLC

08/26/2009 Unknown

882 ROCALTROL Oral Solution 1 mcg/mL (15 mL bottle) Validus Pharmaceuticals LLC

08/26/2009 Unknown

883 ROGAINE (FOR MEN)

Topical Solution

2% McNeil-PPC, Inc. 06/1998 - 05/1999 Unknown

884 ROGAINE (FOR WOMEN)

Topical Solution

2% McNeil-PPC, Inc. 06/1998 - 05/1999 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 885 ROGAINE EXTRA

STRENGTH (FOR MEN)

Topical Solution

5% McNeil-PPC, Inc. 2004 Unknown

886 ROWASA Rectal Enema 4 gm/60 mL Meda Pharmaceutical Inc.

2/2011 Unknown

887 ROWASA Rectal Enema 4 gm/60 mL Meda Pharmaceuticals Inc.

2009 Unknown

888 RYTHMOL SR Extended-release Capsules

425 mg GlaxoSmithKline LLC

Unknown Unknown



10/22/2013 Unknown



10/22/2014 Unknown

891 SALAGEN Tablets 5 mg MGI Pharma, Inc. 12/2004 Unknown 892 SALAGEN Tablets 7.5 mg MGI Pharma, Inc. 03/2006 - 01/2007 Unknown 893 SANDOSTATIN Injection eq. 0.05 mg base/mL Novartis


04/13/2005 Unknown

894 SANDOSTATIN Injection eq. 0.1 mg base/mL Novartis Pharmaceuticals Corporation

04/13/2005 Unknown

895 SANDOSTATIN Injection eq. 0.2 mg base/mL Novartis 04/13/2005 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Pharmaceuticals Corporation

896 SANDOSTATIN Injection eq. 0.5 mg base/mL Novartis Pharmaceuticals Corporation

04/13/2005 Unknown

897 SANDOSTATIN Injection eq. 1 mg base/mL Novartis Pharmaceuticals Corporation

04/13/2005 Unknown

898 SEASONALE Tablets 0.15 mg; 0.03 mg Duramed Pharmaceuticals, Inc.

9/7/2006 Unknown

899 SEASONIQUE Tablets 0.15 mg/0.03 mg and 0.01 mg

Teva Branded Pharmaceutical Products

07/28/2010 Unknown

900 SECTRAL Capsules eq. 200 mg base Wyeth Laboratories, Inc.


901 SECTRAL Capsules eq. 400 mg base Wyeth Laboratories, Inc.


902 SEPTOCAINE Injection 4% and 1:200,000 Deproco, Inc. 01/2015 Unknown 903 SEPTOCAINE Injection 4% and 1:100,000 Deproco, Inc. 01/2015 Unknown 904 SILVADENE Cream 1% King Pharmaceuticals,

Inc. Prior to 1/1/1999 Unknown

905 SINEMET Tablets 10 mg; 100 mg Bristol-Myers Squibb Company

05/2001 - 05/2002 Unknown

906 SINEMET Tablets 25 mg; 250 mg Bristol-Myers Squibb Company

05/2001 - 05/2002 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 907 SINEMET Tablets 25 mg; 100 mg Bristol-Myers Squibb

Company 05/2001 - 05/2002 Unknown

908 SINGULAIR Oral Granules 4 mg Merck Sharp & Dohme Corp

8/7/2013 Unknown

909 SKELAXIN Tablets 800 mg King Pharmaceuticals, LLC

04/01/2010 Unknown

910 SODIUM EDECRIN Powder, for Solution

50 mg/vial (single dose vial for preparation of IV solution)

Aton Pharma, Inc. 01/2015 - 01/2016 Unknown

911 SOLARAZE Gel 3% Fougera Pharmaceuticals, Inc.

11/21/2013 Unknown

912 SOMA Tablet 250 mg Meda Pharmaceuticals

9/13/2010 Unknown

913 SORIATANE Capsules 10 mg Stiefel Laboratories Inc.

7/22/2013 Unknown

914 SORIATANE Capsules 25 mg Stiefel Laboratories Inc.

7/22/2013 Unknown

915 SPECTRACEF Tablets 200 mg Vansen Pharma, Inc. Unknown Unknown 916 SPECTRACEF Tablets 400 mg Vansen Pharma, Inc. Unknown Unknown 917 SPORANOX Capsule 100 mg Janssen Research &

Development, LLC 2/2005; 6/2005 Unknown

918 STALEVO 100 Film-coated Tablets

25 mg, 100 mg, 200 mg Orion Pharma 06/2014 Unknown

919 STALEVO 100 Film-coated 25 mg, 100 mg, 200 mg Orion Pharma 10/2012 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Tablets


31.25 mg, 125 mg, 200 mg

Orion Pharma 4/2012 Unknown


31.25 mg, 125 mg, 200 mg



37.5mg, 150 mg, 200 mg Orion Pharma 06/2014 Unknown


37.5 mg, 150 mg, 200 mg Orion Pharma 10/2012 Unknown















931 STELEVO 100 Film-coated 25 mg, 100 mg, 200 mg Orion Pharma 10/2013 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Tablets

932 STELEVO 125 Film-coated Tablets

31.25 mg, 125 mg, 200 mg






935 STRATTERA Capsules 100 mg Eli Lilly and Company

05/2017 Unknown


05/2017 Unknown


05/2017 Unknown


05/2017 Unknown


05/2017 Unknown


05/2017 Unknown


05/2017 Unknown

942 SULAR Extended-release Tablets

17 mg Shionogi Inc. 2/2012 - 2/2013 Unknown

943 SULAR Extended- 8.5 mg Shionogi Inc. 2/2012 - 2/2013 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing release Tablets

944 SULAR Extended-release Tablets

34 mg Shionogi Inc. 2/2012 - 2/2013 Unknown

945 SYNALAR Cream 0.025% Medimetriks Pharmaceuticals, Inc.

12/2012 Unknown

946 SYNALAR Cream 0.01% Medimetriks Pharmaceuticals, Inc.

Unknown Unknown

947 SYNALAR Ointment 0.025% Medimetriks Pharmaceuticals, Inc.

12/2012 Unknown

948 SYNALAR Solution 0.01% Medimetriks Pharmaceuticals, Inc.

11/2012 Unknown

949 SYNALGOS-DC Capsules 356.4 mg/30 mg/16 mg Sun Pharmaceutical Industries, Inc.

10/01/2012 Unknown

950 TACLONEX Ointment 0.005%/0.064% LEO Pharma A/S 04/2014 Unknown 951 TAMBOCOR Tablets 50 mg 3M Pharmaceuticals 10/2002 Unknown 952 TAMBOCOR Tablets 100 mg 3M Pharmaceuticals 10/2002 Unknown 953 TAMBOCOR Tablets 150 mg 3M Pharmaceuticals 10/2002 Unknown 954 TARGRETIN Capsules 75 mg Valeant


12/2015 Unknown

955 TARKA Extended-release Tablets

1 mg Trandolapril, 240 mg Verapamil Hydrochloride

AbbVie 02/25/2015 Unknown






Entered the Market

Date Authorized

Generic Ceased

Marketing 957 TARKA Extended-

release Tablets 4 mg Trandolapril, 240 mg Verapamil Hydrochloride





959 TASMAR Tablets 100 mg Valeant Pharmaceuticals North America, LLC

07/2004 Unknown

960 TAXOTERE Injection Concentrate

20 mg/mL Sanofi Aventis US LLC

03/2011 Unknown

961 TAXOTERE Injection Concentrate

80 mg/4 mL Sanofi Aventis US LLC

03/2011 Unknown

962 TAZORAC Cream 0.05% Allergan 10/2016 Unknown 963 TAZORAC and

AVAGE Cream 0.1% Allergan 10/2016 Unknown

964 TEGRETOL XR Tablets 100 mg Novartis Pharmaceuticals Corporation

03/2016 Unknown


06/15/2009 Unknown


06/15/2009 Unknown

967 TEMODAR Capsules 20 mg Merck Sharp & Dohme Corporation

8/12/2013 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 968 TEMODAR Capsules 250 mg Merck Sharp &

Dohme Corporation 8/12/2013 Unknown


8/12/2013 Unknown


8/12/2013 Unknown


8/12/2013 Unknown


8/12/2013 Unknown

973 TENUATE Immediate-release Tablets

25 mg Actavis Laboratories UT Inc.

12/20/1996 Unknown

974 TENUATE DOSPAN Controlled-release Tablets

75 mg Actavis Laboratories UT, Inc.

07/24/1994 Unknown

975 TESSALON Capsules 100 mg Forest Laboratories, Inc.


976 TESSALON Capsules 200 mg Forest Laboratories, Inc.

04/1999 - 04/2000 Unknown

977 TESTIM Gel 50 mg in 5 g Auxilium Pharmaceuticals, Inc.

06/09/2014 Unknown

978 TIAZAC Extended-release Capsules

120 mg Valeant Pharmaceuticals North America, LLC

08/20/2014 Unknown

979 TIAZAC Extended-release

180 mg Valeant Pharmaceuticals

08/20/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Capsules North America, LLC



08/20/2014 Unknown



08/20/2014 Unknown



08/20/2014 Unknown



08/20/2014 Unknown

984 TIGAN Injection 100 mg/mL Par Sterile Products, LLC

06/01/2012 Unknown

985 TIKOSYN Capsules 0.125 mg Pfizer 05/01/2016 Unknown 986 TIKOSYN Capsules 0.25 mg Pfizer 05/01/2016 Unknown 987 TIKOSYN Capsules 0.5 mg Pfizer 05/01/2016 Unknown 988 TIMOPTIC-XE Solution 0.5% Aton Pharma, a

division of VPNA LLC

11/1993 Unknown

989 TINDAMAX Tablets 250 mg Mission Pharmacal Company

06/07/2012 Unknown

990 TINDAMAX Tablets 500 mg Mission Pharmacal Company

06/07/2012 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 991 TOBI Solution for

Inhalation 300 mg/5 mL ampule Novartis


07/2014 Unknown

992 TOBRADEX Opthalmic Suspension

0.3%, 0.1% Novartis Pharmaceuticals Corporation

01/02/2009 Unknown

993 TOFRONIL PM Capsules 100 mg Mallinckrodt Inc. 4/2006 Unknown 994 TOFRONIL PM Capsules 150 mg Mallinckrodt Inc. 4/2006 Unknown 995 TOFRONIL PM Capsules 125 mg Mallinckrodt Inc. 4/2006 Unknown 996 TOFRONIL PM Capsules 75 mg Mallinckrodt Inc. 4/2006 Unknown 997 TOPROL XL Extended-

release Tablets 25 mg Aralez

Pharmaceuticals Trading DAC

01/2018 Unknown

998 TOPROL XL Extended-release Tablets

50 mg Aralez Pharmaceuticals Trading DAC

01/2018 Unknown



01/2018 Unknown



01/2018 Unknown

1001 TORADOL Tablets 10 mg Syntex (U.S.A.) Inc. Prior to 1/1/1999 Unknown 1002 TRANDATE Tablets 300 mg County Line

Pharmaceuticals, 12/01/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing LLC

1003 TRANDATE Tablets 200 mg County Line Pharmaceuticals, LLC

12/01/2014 Unknown

1004 TRANDATE Tablets 100 mg County Line Pharmaceuticals, LLC

12/01/2014 Unknown

1005 TRICOR Tablets 48 mg AbbVie Inc. 04/2014 Unknown 1006 TRICOR Tablets 145 mg AbbVie Inc. 04/2014 Unknown 1007 TRILEPTAL Oral

Suspension 300 mg/5 mL Novartis


01/04/2011 Unknown

1008 TRILIPIX Delayed Release Capsules

45 mg AbbVie Inc. 07/15/2013 Unknown







1012 TRI-NORINYL Tablets 0.5 mg, 1 mg, 0.5 mg; Mayne Pharma LLC 08/2016 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 0.035 mg, 0.035 mg, 0.035 mg

1013 TRI-NORINYL Tablets 0.5 mg, 1 mg, 0.5 mg; 0.035 mg, 0.035 mg, 0.035 mg

Mayne Pharma LLC 1/12/2005 Unknown

1014 TUSSIONEX Extended-Release Suspension

10 mg hydrocodone bitartrate & 8 mg chlorpheniramine maleate per 5 mL

UCB, Inc. 10/2010 Unknown

1015 ULTRAM Extended-release Tablets

100 mg Valeant Pharmaceuticals North America LLC

01/16/2006 Unknown



01/16/2006 Unknown



01/16/2006 Unknown

1018 ULTRAVATE Cream 0.05% Bristol-Myers Squibb Company

11/2004 - 10/2005 Unknown

1019 ULTRAVATE Ointment 0.05% Bristol-Myers Squibb Company

11/2004 - 10/2005 Unknown

1020 UNITHROID Tablets 0.025 mg Jerome Stevens Pharmaceuticals, Inc.

08/2002 - 07/2003 Unknown

1021 UNITHROID Tablets 0.05 mg Jerome Stevens 08/2002 - 07/2003 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Pharmaceuticals, Inc.


08/2002 - 07/2003 Unknown


08/2002 - 07/2003 Unknown


08/2002 - 07/2003 Unknown


08/2002 - 07/2003 Unknown


08/2002 - 07/2003 Unknown


08/2002 - 07/2003 Unknown


08/2002 - 07/2003 Unknown


08/2002 - 07/2003 Unknown


08/2002 - 07/2003 Unknown

1031 UREX Tablets 1 gram County Line Pharmaceuticals, LLC

Unknown Unknown

1032 UROCIT-K Extended-release Tablets

15 mEQ (1620 mg) per tablet

Mission Pharmacal 12/23/2013 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 1033 UROCIT-K Extended-

release Tablets 540 mg (5 mEq per tablet) Mission Pharmacal 11/2007 Unknown

1034 UROCIT-K Extended-release Tablets

1080 mg (10 mEq per tablet)

Mission Pharmacal 11/2007 Unknown

1035 URSO 250 Tablets 250 mg Allergan Sales, LLC 07/06/2009 Unknown 1036 URSO FORTE Tablets 500 mg Allergan Sales, LLC 07/06/2009 Unknown 1037 VAGISTAT-1 Vaginal

Ointment 6.50% Bristol-Myers Squibb

Company 02/1998 - 02/1999 Unknown

1038 VANCOCIN Capsules 250 mg ANI Pharmaceuticals Inc.

10/26/2015 Unknown

1039 VANCOCIN Capsules 125 mg ANI Pharmaceuticals Inc.

10/26/2015 Unknown

1040 VANOS Cream 0.1% Medicis Pharmaceutical Corporation

01/2014 Unknown

1041 VASERETIC Tablets 10 mg/25 mg Valeant Pharmaceuticals North America, LLC

10/31/1986 Unknown

1042 VASOTEC Tablets 5 mg Valeant Pharmaceuticals North America, LLC

12/24/1985 Unknown


12/24/1985 Unknown

1044 VASOTEC Tablets 2.5 mg Valeant 07/26/1988 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Pharmaceuticals North America, LLC


12/24/1985 Unknown

1046 VECTICAL Ointment 3 mcg/g Galderma Laboratories, L.P.

02/28/2012 Unknown

1047 VENLAFAXINE HYDROCHLORIDE EXTENDED RELEASE TABLETS

Tablet, Extended Release


04/2010 Unknown




04/2010 Unknown



37.5 mg Osmotica Pharmaceutical US LLC

04/2010 Unknown




04/2010 Unknown



37.5 mg Osmotica Pharmaceutical US LLC

04/2010 Unknown

1052 VENLAFAXINE HYDROCHLORIDE

Tablet, Extended

75 mg Osmotica Pharmaceutical US

04/2010 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing EXTENDED RELEASE TABLETS

Release LLC




04/2010 Unknown




04/2010 Unknown

1055 VENOFER Injection 2% w/v iron (Fe) Luitpold Pharmaceuticals, Inc.

10/02/08 Unknown

1056 VERELAN Sustained-release Capsules

120 mg Recro Gainesville LLC

5/17/1999 Unknown



5/17/1999 Unknown



5/17/1999 Unknown



5/17/1999 Unknown

1060 VERELAN PM Extended-release Capsules


11/2006 - 11/2007 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 1061 VERELAN PM Extended-

release Capsules


11/2006 - 11/2007 Unknown

1062 VERELAN PM Extended-release Capsules


11/2006 - 11/2007 Unknown

1063 VFEND Powder for Oral Suspension

40 mg/mL (75 mL when reconstituted)

PF Prism C.V. 12/16/2013 Unknown

1064 VFEND Tablets 50 mg PF Prism C.V. 07/08/2010 Unknown 1065 VFEND Tablets 200 mg PF Prism C.V. 07/08/2010 Unknown 1066 VIDAZA Injection,

Powder, Lyophylized, for Solution

100 mg single-use vial Celgene Corporation 09/16/2013 Unknown

1067 VIRAMUNE Oral Suspension

50 mg/5 mL Boehringer-Ingleheim Pharmaceuticals, Inc.

05/21/2012 Unknown

1068 VIRAMUNE Tablets 200 mg Boehringer-Ingleheim Pharmaceuticals, Inc.

05/21/2012 Unknown

1069 VIROPTIC Ophthalmic Solution

1% Monarch Pharmaceuticals, LLC

08/20/2012 Unknown

1070 VIVELLE-DOT Transdermal System

0.1 mg Novartis Pharmaceuticals Corporation

12/2014 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 1071 VIVELLE-DOT Transdermal

System 0.075 mg Novartis


12/2014 Unknown



12/2014 Unknown



12/2014 Unknown



12/2014 Unknown

1075 VOGELXO Gel 50 mg Upsher-Smith Laboratories

06/2014 Unknown

1076 VOLTAREN Delayed-release Tablets



1077 VOLTAREN Delayed-release Tablets



1078 VOLTAREN Gel 1% GlaxoSmithKline Consumer Healthcare

07/2016 Unknown

1079 VOLTAREN XR Extended-release Tablets


05/22/2000 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 1080 XALATAN Ophthalmic

Solution 0.005% (125 mcg/2.5 mL) Pharmacia and


1081 XANAX Tablets 0.25 mg Pharmacia and Upjohn Company

06/17/2003 Unknown

1082 XANAX Tablets 0.5 mg Pharmacia and Upjohn Company

06/18/2003 Unknown

1083 XANAX Tablets 1 mg Pharmacia and Upjohn Company

06/18/2003 Unknown

1084 XANAX Tablets 2 mg Pharmacia and Upjohn Company

06/18/2003 Unknown

1085 XANAX XR Extended-release Tablets

0.5 mg Pharmacia and Upjohn

11/16/2005 Unknown



11/16/2005 Unknown



11/16/2005 Unknown



11/16/2005 Unknown

1089 XENAZINE Tablets 25 mg Valeant Pharmaceuticals North America, LLC

07/20/2015 Unknown

1090 XENAZINE Tablets 12.5 mg Valeant Pharmaceuticals North America, LLC

07/20/2015 Unknown

1091 XOPENEX Inhalation 0.63 mg/3 mL Oak Pharmaceuticals, 08/2012 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing Solution Inc.

1092 XOPENEX Inhalation Solution

0.31 mg/3 mL Oak Pharmaceuticals, Inc.

08/2012 Unknown

1093 XOPENEX Inhalation Solution

1.25 mg/3 mL Oak Pharmaceuticals, Inc.

08/2012 Unknown

1094 YASMIN Tablets 3 mg; 0.03 mg Bayer HealthCare Pharmaceuticals Inc.

05/09/2008 Unknown

1095 ZARONTIN Capsules 250 mg Parke-Davis Division of Pfizer Inc.

10/12/2015 Unknown

1096 ZARONTIN Oral Solution 250 mg/5 mL Parke-Davis Division of Pfizer Inc.

10/12/2015 Unknown

1097 ZAROXOLYN Tablets 2.5 mg UCB, Inc. 11/2002 - 10/2003 Unknown 1098 ZAROXOLYN Tablets 5 mg UCB, Inc. 11/2002 - 10/2003 Unknown 1099 ZAROXOLYN Tablets 10 mg UCB, Inc. 11/2002 - 10/2003 Unknown 1100 ZEBETA Tablets 5 mg Lederle Laboratories 08/2000 - 08/2001 Unknown 1101 ZEBETA Tablets 10 mg Lederle Laboratories 08/2000 - 08/2001 Unknown 1102 ZEGERID Capsules 40 mg Salix Pharmaceuticals,

Inc. 02/27/2006 Unknown

1103 ZEGERID Capsules 20 mg Salix Pharmaceuticals, Inc.

02/27/2006 Unknown


02/27/2006 Unknown


02/27/2006 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 1106 ZEMPLAR Capsules 2 mcg AbbVie Inc. 03/2014 Unknown 1107 ZEMPLAR Capsules 1 mcg AbbVie Inc. 03/2014 Unknown 1108 ZENPEP Delayed

Release Capsules

5000 lipase USP units Eurand Pharmaceuticals, Ltd.

12/2/2009 Unknown

1109 ZIAC Tablets 2.5 mg; 6.25 mg Lederle Laboratories 07/2000 - 07/2001 Unknown 1110 ZIAC Tablets 5 mg; 6.25 mg Lederle Laboratories 07/2000 - 07/2001 Unknown 1111 ZIAC Tablets 10 mg; 6.25 mg Lederle Laboratories 07/2000 - 07/2001 Unknown 1112 ZITHROMAX Powder for

Oral Suspension

100 mg/5 mL (300 mg bottle, 15 mL when mixed)


1113 ZITHROMAX Powder for Oral Suspension

200 mg/5 mL (600 mg bottle, 15 mL when mixed)



200 mg/5 mL (900 mg bottle, 22.5 mL when mixed)



1 gram (single dose packet)



1200 mg (30 mL when mixed)


1117 ZITHROMAX Tablets 250 mg Pfizer Inc. 02/01/2005 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 1118 ZITHROMAX Tablets 500 mg Pfizer Inc. 02/01/2005 Unknown 1119 ZITHROMAX Tablets 600 mg Pfizer Inc. 2/1/2005 Unknown 1120 ZOLOFT Oral

Concentrate 20 mg/mL Pfizer Inc. 03/20/2006 Unknown

1121 ZOLOFT Tablets 25 mg Pfizer Inc. 03/20/2006 Unknown 1122 ZOLOFT Tablets 50 mg Pfizer Inc. 03/20/2006 Unknown 1123 ZOLOFT Tablets 100 mg Pfizer Inc. 03/20/2006 Unknown 1124 ZONALON and

PRUDOXIN Cream 5% Mylan

Pharmaceuticals, Inc. 03/2016 Unknown

1125 ZOVIRAX Ointment 5% Valeant Pharmaceuticals North America LLC

04/2014 Unknown

1126 ZOVIRAX Suspension 200 mg per 5 mL Mylan Pharmaceuticals Inc.

09/2014 Unknown

1127 ZUTRIPRO Oral Solution 5 mg/4 mg/60 mg per 5 mL

Cypress Pharmaceutical, Inc.

01/2014 Unknown

1128 ZYFLO Extended-release Tablets

600 mg Chiesi USA, Inc. 04/2017 Unknown

1129 ZYVOX Oral Suspension

100 mg/5 mL Pharmacia and Upjohn Company

12/2015 Unknown

1130 ZYVOX Tablets 600 mg Pharmacia and Upjohn Company

06/2015 Unknown

1131 ZYVOX Tablets 600 mg Pharmacia and Upjohn Company

12/2015 Unknown



Entered the Market

Date Authorized

Generic Ceased

Marketing 1132 ZYVOX Tablets 600 mg Pharmacia and

Upjohn Company 06/2015 Unknown

FDA Listing of Authorized Generics · FDA Listing of Authorized Generics as of March 28, 2018 ....

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Transcript of FDA Listing of Authorized Generics · FDA Listing of Authorized Generics as of March 28, 2018 ....