FDA Philippines Provisional List of Comparator Products

Republic of the Philippines

Department of Health

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City, Philippines Trunk Line +63 2 857 1900 Fax +63 2 807 0751 Website: www.fda.gov.ph Email: [email protected]

1

Provisional List of Comparator Products for In vivo and/or In vitro Equivalence Studies

(as of 03 May 2016)

Active Ingredient Dosage Strength

and Form

Comparator

Drug

Marketing

Authorization Holder

[Manufacturer]

Registration

Number

Aceclofenac 100 mg Tablet CLANZA One Pharma Co., Inc.

[Korea United Pharm. Inc.

– Korea]

DR-XY30590

100 mg Softgel

Capsule

CLANZA S One Pharma Co., Inc.


– Korea]

DR-XY34671

200 mg

Controlled-

Release Tablet

CLANZA CR One Pharma Co., Inc.


– Korea]

DR-XY39980

Acetazolamide 250 mg Tablet DIAMOX Wyeth Phils., Inc. [Wyeth

Lederle Ltd. – India]

DR-2928

CETAMID

Euro Generics Int’l Phils.,

Inc. [The ACME Labs.

Ltd. – Bangladesh]

DRP-1877

(DR-XY28768)

Aciclovir 200 mg Tablet ZOVIRAX GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome S.A.

– Spain]

DR-XY2013

400 mg Tablet ZOVIRAX GlaxoSmithKline Phils.,


– Spain]

DR-XY8177

800 mg Tablet ZOVIRAX GlaxoSmithKline Phils.,


– Spain]

DR-XY19137

200 mg/5 mL Oral

Suspension

HERPEX Metropolitan Pharm’l

Products, Inc. [Korea

United Pharm. Inc. –

Korea]

DR-XY29944

Acetylsalicylic Acid

(Aspirin)

30 mg Tablet COR-30 Pascual Labs., Inc.

[Pascual Labs., Inc.]

DR-XY17534

80 mg Tablet ASPILETS LR Imperial, Inc. [Amherst

Labs., Inc.]

DR-2350

100 mg Tablet BAYER

ASPIRIN

Bayer Phils., Inc. [Bayer

Bitterfeld GmbH –

DRGDA

00000002

2

Germany]

300 mg Tablet BAYER

ASPIRIN

Bayer Phils., Inc. [Bayer

Bitterfeld GmbH –

Germany]

DR-XY35870

325 mg Tablet Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-5053

500 mg Tablet CORTAL 500 Pharma-Rex, Inc. [Interphil

Labs., Inc.]

DR-XY43005

30 mg Enteric-

coated Tablet

ASPEN EuroHealth Care

Exponents, Inc. [Lloyd

Labs., Inc.]

DR-XY31931

80 mg Enteric-

coated Tablet

ASPILETS- EC LR Imperial, Inc. [Amherst

Labs., Inc.]

DR-XY31497

ASPEN EuroHealth Care


Labs., Inc.]

DRP-1369

100 mg Enteric-

coated Tablet

BAYPRIN EC Bayer Phils., Inc. [Bayer

Pharma AG – Germany]

DR-XY23747

100 mg Enteric-

coated Capsule

ANTHROM Yung Shin Phils., Inc.

[Y.S.P. Industries (M) Sdn.

Bhd.– Malaysia]

DRP-1045

Albendazole 400 mg Chewable

Tablet

ZENTEL GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham

(Phils.)]

DR-XY13050

ESKAZOLE* [GlaxoSmithKline] Not available

locally

*This is the recommended comparator product by WHO and

should be purchased from a well regulated market with stringent

regulatory authority i.e., from countries participating in the

International Conference on Harmonization (ICH).

HYEMEX** Blue Sky Trading Co., Inc.

[Swisspharma Research

Labs., Inc.]

DR-XY30860

**HYEMEX may be considered as the alternative comparator

product once equivalence with ZENTEL or ESKAZOLE has been

satisfactorily demonstrated.

Unbranded*** Blue Sky Trading Co., Inc.


Labs., Inc.]

DR-XY29062

***Unbranded Albendazole 400 mg Chewable Tablet may be

considered as the alternative comparator product once equivalence

with ZENTEL or ESKAZOLE has been satisfactorily

demonstrated.

200 mg/5 mL Oral ZENTEL GlaxoSmithKline Phils., DR-XY21457

3

Suspension Inc. [SmithKline Beecham

(Phils.)]

Unbranded**** Blue Sky Trading Co., Inc.


Labs., Inc.]

DR-XY31624

****Unbranded Albendazole 200 mg/5 mL Oral Suspension may

be considered as the alternative comparator product once

equivalence with ZENTEL or ESKAZOLE has been satisfactorily

demonstrated.

Alendronic Acid (as

Alendronate sodium)

70 mg Tablet FOSAMAX Merck Sharp & Dohme

(I.A.) Corp. [Merck Sharp

& Dohme (Italia) S.p.A. –

Italy]

DR-XY27118

Alendronic Acid (as

Alendronate sodium)

+ Cholecalciferol

(Vitamin D3)

70 mg/2,800 IU

Tablet

FOSAVANCE Merck Sharp & Dohme

(I.A.) Corp. [Frosst Iberica

S.A. – Spain]

DR-XY31364

70 mg/5,600 IU

Tablet

FOSAVANCE Merck Sharp & Dohme


S.A. – Spain]

DR-XY35366

Alfuzosin

hydrochloride

2.5 mg Tablet XATRAL Sanofi-Aventis Phils., Inc.

[Sanofi-Winthrop Industrie

S.A. – France]

DRP-191

5 mg Sustained-

release Tablet

XATRAL SR Sanofi-Aventis Phils., Inc.


S.A. – France]

DR-XY23216

10 mg Sustained-

release Tablet

XATRAL OD Sanofi-Aventis Phils., Inc.


S.A. – France]

DRP-072

Allopurinol 100 mg Tablet ZYLOPRIM Aspen Phils., Inc. [Aspen

Bad Oldesloe GmbH –

Germany]

DR-273

300 mg Tablet ZYLOPRIM Aspen Phils., Inc. [Aspen


Germany]

DR-10173

Ambroxol

hydrochloride

15 mg Lozenge STREPSILS

CHESTY

COUGH

Zuellig Pharma Corp.

[Reckitt Benckiser

Healthcare Manufacturing

(Thailand) Ltd. – Thailand]

DR-XY34819

STREPSILS

CHESTY

COUGH


[Reckitt Benckiser



DR-XY42567

20 mg Lozenge MUCOANGIN Boehringer Ingelheim

(Phil.), Inc. [Delpharm

Reims S.A.S. – France]

DR-XY33181

4

30 mg Tablet MUCOSOLVAN Boehringer Ingelheim

(Phil.), Inc. [Interphil

Labs., Inc.]

DR-XY145

MUCOSOLVAN Boehringer Ingelheim

(Phil.), Inc. [Boehringer

Ingelheim Pharma GmbH

& Co. KG – Germany]

DR-XY41618

ZOBRIXOL Natrapharm, Inc. [Hizon

Labs., Inc.]

DR-XY5348

MYRACOF Medichem Pharm’ls, Inc.

[Amherst Labs., Inc.]

DR-XY15803

AMBROLEX GlaxoSmithKline Phils.,

Inc. [SmithKline Beecham]

DRP-4352

(DR-XY21034)

75 mg Sustained-

Release (Retard)

Capsule


(Phil.), Inc. [PT.

Boehringer Ingelheim

Indonesia – Indonesia]

DR-XY18553





DR-XY41726

AMBROLEX

OD

GlaxoSmithKline Phils.,

Inc. [China Resources

Zizhu Pharm’l Co., Ltd. –

China]

DR-XY25555

Amiodarone

hydrochloride

200 mg Tablet CORDARONE Sanofi-Aventis Phils., Inc.


S.A. – France]

DRP-043

Amlodipine besilate 5 mg Tablet NORVASC Pfizer, Inc. [Pfizer

Australia Pty. Ltd. –

Australia]

DRP-3419

(DR-XY15374)

10 mg Tablet NORVASC Pfizer, Inc. [Pfizer


Australia]

DRP-3429

(DR-XY16948)

Amlodipine besilate

+ Atorvastatin

calcium

5 mg/10 mg

Tablet

ENVACAR /

NORVASC

PROTECT

Pfizer, Inc. [Goedecke

GmbH – Germany]

DRP-2791

(DR-XY30120)

5 mg/20 mg

Tablet

ENVACAR /

NORVASC

PROTECT


GmbH – Germany]

DR-XY30121

10 mg/10 mg

Tablet

ENVACAR /

NORVASC

PROTECT


GmbH – Germany]

DR-XY30125

10 mg/20 mg

Tablet

ENVACAR /

NORVASC


GmbH – Germany]

DR-XY30122

5

PROTECT

Amlodipine besilate

+ Valsartan

5 mg/80 mg

Tablet

EXFORGE Novartis Healthcare Phils.,

Inc. [Novartis

Farmaceutica S.A. – Spain]

DRP-4862

(DR-XY34217)

5 mg/160 mg

Tablet


Inc. [Novartis


DRP-4869

(DR-XY34216)

10 mg/160 mg

Tablet


Inc. [Novartis


DRP-4868

(DR-XY34218)

Amoxicillin

trihydrate

250 mg Capsule AMOXIL GlaxoSmithKline Phils.,

Inc. [Glaxo Wellcome

Production – France]

DR-9037-L

500 mg Capsule AMOXIL GlaxoSmithKline Phils.,



DR-X1753-L

100 mg/mL

Powder or

Granules for Oral

Suspension

AMOXIL GlaxoSmithKline Phils.,



DR-9035

125 mg/5 mL

Powder or

Granules for Oral

Suspension

AMOXIL GlaxoSmithKline Phils.,



DR-9036

250 mg/5 mL

Powder or

Granules for Oral

Suspension

AMOXIL

FORTE




DR-X6448-L

Anastrozole 1 mg Tablet ARIMIDEX AstraZeneca Pharm’ls

(Phils.), Inc. [AstraZeneca

Pharm’ls LP – USA]

DR-XY24551

Aripiprazole 5 mg Tablet ABILIFY Otsuka Phils. Pharm’l, Inc.

[Korea Otsuka Pharm’l

Co., Ltd. – Korea]

DR-XY32978

10 mg Tablet ABILIFY Otsuka Phils. Pharm’l, Inc.



DR-XY30931

15 mg Tablet ABILIFY Otsuka Phils. Pharm’l, Inc.



DR-XY30932

10 mg Orally

Disintegrating

Tablet

ABILIFY

DISCMELT

Otsuka Phils. Pharm’l, Inc.

[Bristol-Myers Squibb

Manufacturing Co. –

DR-XY35464

6

Puerto Rico]

15 mg Orally

Disintegrating

Tablet

ABILIFY

DISCMELT

Otsuka Phils. Pharm’l, Inc.


Manufacturing Co. –

Puerto Rico]

DR-XY35465

Artemether +

Lumefantrine

20 mg/120 mg

Tablet

COARTEM

Novartis Healthcare Phils.,

Inc. [Beijing Novartis

Pharma Ltd. – China]

DR-XY25933

20 mg/120 mg

Dispersible Tablet

COARTEM

Dispersible


Inc. [Novartis Pharm’ls

Corp. – USA]

DR-XY39663

Ascorbic Acid 100 mg Tablet Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DRHR-1296

(DR-5074)


Labs., Inc.]

DRHR-1655

(DR-5051)


Labs., Inc.] DRHR-1295

(DR-5052)

1 g Tablet POTEN-CEE

FORTE

Pascual Labs., Inc.

[VitaQuest Int’l, Inc. –

USA]

DR-XY32613

100 mg Chewable

Tablet

CEELIN

CHEWABLES

Pediatrica, Inc. [United

Labs., Inc.]

DRHR-731

500 mg Chewable

Tablet

CECON Abbott Labs. Phils., Inc.

[PT. Abbott Indonesia –

Indonesia]

DRHR-1608

POTEN-CEE Pascual Labs., Inc.


DR-XY22592

500 mg Sugar-

coated Tablet

POTEN-CEE Pascual Labs., Inc.


DR-9468

500 mg Sustained-

release Tablet

GNC TR

VITAMIN C

General Nutrition Center

[Nutra Manufacturing, Inc

– USA]

DRHR-1092

1 g Sustained-

release Tablet

SELVON CEE

SR

Prosel Pharm’ls &

Distributors, Inc. [Lloyd

Labs., Inc.]

DR-XY21922

Ascorbic Acid (as

Calcium ascorbate)

500 mg Capsule CAL-CEE Gold Life Distribution

Phils., Inc. [Lloyd Labs.,

Inc.]

DRHR-911

500 mg Tablet ESTER-C Nutri-Health, Inc. [Lloyd

Labs., Inc.]

DRHR-1433

Ascorbic Acid (as

Sodium ascorbate)

500 mg Capsule

SUPER C JECR Entrepreneurship

Program, Inc. [Hizon

Labs., Inc.]

DRHR-890

NUTRACEE D.B. Manix Int’l, Inc. DRHR-904

7

[Lloyd Labs., Inc.]

HBS IMMUNO-

C

Personal Collection Direct

Selling [Lloyd Labs., Inc.]

DRHR-918

VITAL C Vital C Health Products,

Inc. [Am-Europharma

Corp.]

DRHR-940

FERN-C Filipino Entrepreneurs’

Resources Network

(FERN), Inc. [Northfield

Labs., Inc.]

DRHR-1009

Atenolol 50 mg Tablet TENORMIN AstraZeneca Pharm’ls


UK Ltd. – United

Kingdom]

DR-XY14043

100 mg Tablet TENORMIN AstraZeneca Pharm’ls


UK Ltd. – United

Kingdom]

DR-XY14058

Atorvastatin calcium 10 mg Tablet LIPITOR Pfizer, Inc. [Pfizer Ireland

Pharm’ls – Ireland]

DRP-3361

(DR-XY23024)

20 mg Tablet LIPITOR Pfizer, Inc. [Pfizer Ireland


DRP-3362

(DR-XY23025)



DRP-3363

(DR-XY23026)



DRP-3364

(DR-XY28046)

Azathioprine sodium 50 mg Tablet IMURAN Aspen Phils., Inc. [Excella

GmbH – Germany]

DR-XY9450

Azithromycin

dihydrate

250 mg Tablet ZITHROMAX Pfizer, Inc. [Pfizer


Australia]

DRP-3379

(DR-XY16629)

500 mg Tablet ZITHROMAX Pfizer, Inc. [Pfizer


Australia]

DRP-3366

(DR-XY26462)

200 mg/5 mL

Powder or

Granules for Oral

Suspension

ZITHROMAX Pfizer, Inc. [Haupt Pharma

Latina S.r.l. – Italy]

DRP-3367

(DR-XY16630)

2 g Extended

Release Powder

for Oral

Suspension

ZMAX ONE

DOSE

Pfizer, Inc. [Pfizer Pharm’l

LLC – Puerto Rico]

DR-XY31104

8

Azithromycin

monohydrate

250 mg Tablet AZYTH Sandoz Phils. Corp.

[Novartis Ltd. –

Bangladesh]

DRP-1285

500 mg Tablet AZYTH Sandoz Phils. Corp.

[Novartis Ltd. –

Bangladesh]

DRP-1286

200 mg/5 mL

Powder or

Granules for Oral

Suspension

AZYTH Sandoz Phils. Corp. [SC

Sandoz S.r.l – Romania]

DRP-1879

Baclofen 10mg Tablet LIORESAL Novartis Healthcare

Philippines, Inc. [Novartis

Farma S.p.A. – Italy]

DR-X8065

Bambuterol

hydrochloride

10 mg Tablet BAMBEC AstraZeneca Pharm’ls


Pharm’l Co. Ltd. – China]

DR-XY23111

BAMBEC AstraZeneca Pharm’ls


AB – Sweden]

DR-XY39157

Betahistine

hydrochloride

8 mg Tablet SERC Abbott Products Phils., Inc.

[Abbott Healthcare S.A.S.

– France]

DRP-472

[DR-10094]



– France]

DRP-473

[DR-XY20691]



– France]

DR-XY29111

Betahistine mesilate 6 mg Tablet MERISLON HI-Eisai Pharm’l, Inc.


Labs., Inc.]

DR-XY22029

12 mg Tablet MERISLON HI-Eisai Pharm’l, Inc.

[Eisai Co., Ltd. – Japan]

DR-XY28530

Betamethasone 500 mcg Tablet

BETNELAN GlaxoSmithKline Phils.,

Inc. [GlaxoSmithKline

Bangladesh Ltd. –

Bangladesh]

DR-7689

CELESTONE Merck Sharp & Dohme

(I.A.) Corp. [PT. Schering-

Plough Indonesia Tbk. –

Indonesia]

DR-XY7133

9

Betamethasone +

Dexchlorpheniramine

maleate

250 mcg/2 mg

Tablet

CELESTAMINE Merck Sharp & Dohme

(I.A.) Corp. [PT. Merck

Sharp & Dohme Pharma

Tbk. – Indonesia]

DR-XY20881

Bicalutamide 50 mg Tablet CASODEX AstraZeneca Pharm’ls

(Phils.), Inc. [Corden

Pharma GmbH – Germany]

DR-XY26042

150 mg Tablet CASODEX AstraZeneca Pharm’ls

(Phils.), Inc. [Corden

Pharma GmbH – Germany]

DR-XY27244

Biperiden

hydrochloride

2 mg Tablet AKINETON A. Menarini Phils., Inc.

[Abbott GmbH & Co. KG

– Germany

DR-8716

Bisacodyl 5mg Delayed-

Release Tablet

DULCOLAX Boehringer Ingelheim

(Phils.), Inc. [PT.



DR-XY42393

Bisoprolol fumarate 2.5 mg Tablet CONCORE Merck, Inc. (Phils.) [Merck

KgaA – Germany]

DR-XY26678

5 mg Tablet CONCORE Merck, Inc. (Phils.) [PT.

Merck Tbk. – Indonesia]

DR-XY32829

10 mg Tablet CONCORE Merck, Inc. (Phils.) [Merck

KgaA – Germany]

DR-XY29470

Bisoprolol fumarate +

Hydrochlorothiazide

2.5 mg/6.25 mg

Tablet

ZIAC Merck, Inc. (Phils.) [PT.

Merck Tbk. – Indonesia]

DR-XY26004

5 mg/6.25 mg

Tablet

ZIAC Merck, Inc. (Phils.) [Merck

KgaA – Germany]

DR-XY27281

10 mg/6.25 mg

Tablet

ZIAC Merck, Inc. (Phils.) [Merck

KgaA – Germany]

DR-XY27280

Calcitriol 0.25 mcg Softgel

Capsule

ROCALTROL Roche (Phils.), Inc. [R.P.

Scherer GmbH & Co. KG

– Germany]

DR-XY28641

Calcium lactate 325 mg Tablet

Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-XY7941

CALACTATE United Home Products

[United Labs., Inc.]

DRHR-770


Labs., Inc.]

DR-X1961

CALACTATE United Home Products


DR-XY26932

Candesartan cilexetil 8 mg Tablet BLOPRESS Takeda Pharm’ls (Phils.), DR-XY24550

10

Inc. [Takeda Pharm’l Co.,

Ltd. – Japan]

16 mg Tablet BLOPRESS Takeda Pharm’ls (Phils.),

Inc. [Takeda Pharm’l Co.,

Ltd. – Japan]

DR-XY24549

Candesartan cilexetil

+

Hydrochlorothiazide

16 mg/12.5 mg

Tablet

BLOPRESS

PLUS

Takeda Pharm’ls (Phils.),

Inc. [Takeda Italia

Farmaceutici S.p.A. –

Italy]

DR-XY27256

Capecitabine 150 mg Tablet XELODA Roche (Phils.), Inc.

[Productos Roche S.A. de

C.V. – Mexico]

DR-XY38088

500 mg Tablet XELODA Roche (Phils.), Inc.


C.V. – Mexico]

DR-XY38089

Captopril 25 mg Tablet CAPOTEN [Bristol-Myers Squibb


Australia]

Not Available

Locally

Unbranded Ritemed Phils., Inc.


DR-XY33443

Unbranded Ritemed Phils., Inc.

[Sydenham Labs., Inc.]

DRP-166-01

50 mg Tablet CAPOTEN [Bristol-Myers Squibb


Australia]

Not Available

Locally

Carbocisteine 500 mg Capsule SOLMUX Westmont Pharm’ls, Inc.


DRHR-717

LOVISCOL Pfizer, Inc. [Interphil

Labs., Inc.]

DRHR-873

200 mg Chewable

Tablet

SOLMUX

CHEWTAB

Westmont Pharm’ls, Inc.


DRHR-1487

500 mg Chewable

Tablet

SOLMUX

CHEWTAB



DRHR-1488

100 mg/5 mL Oral

Suspension

SOLMUX Westmont Pharm’ls, Inc.


DRHR-752

200 mg/5 mL Oral

Suspension



DRHR-718



DRHR-1398

250 mg/5 mL Oral

Suspension

ROBIKIDS Pfizer, Inc. [Interphil

Labs., Inc.]

DRHR-1051

500 mg/5 mL Oral

Suspension

SOLMUX

FORTE



DRHR-720

Carvedilol 6.25 mg Tablet DILATREND Roche (Phils.), Inc. [Roche

S.p.A. – Italy]

DR-XY25988

25 mg Tablet DILATREND Roche (Phils.), Inc. [Roche

S.p.A. – Italy]

DR-XY22130

11

Cefaclor 250 mg Capsule XELENT Westmont Pharm’ls, Inc.

[Asian Antibiotics, Inc.]

DR-XY25749

500 mg Capsule CECLOR Aspen Phils., Inc.

[Interphil Labs., Inc.]

DR-X8594

XELENT Westmont Pharm’ls, Inc.


DR-XY25753

50 mg/mL Powder

or Granules for

Oral Suspension

CECLOR Aspen Phils., Inc.


DR-XY18121

125 mg/5 mL

Powder or

Granules for Oral

Suspension

CECLOR Aspen Phils., Inc.


DR-X8596

250 mg/5 mL

Powder or

Granules for Oral

Suspension

CECLOR-DS Aspen Phils., Inc.


DR-XY4009-L

375 mg Extended-

Release Tablet

VERZAT ER Rhiza Labs., Inc. [Lloyd

Labs., Inc.]

DRP-650

(DR-XY31990)

CECOGEN Lloyd Labs., Inc. [Lloyd

Labs., Inc.]

DR-XY35853

750 mg Extended-

Release Tablet

VERZEF ER Randril Int’l Co., Inc.

[Lloyd Labs., Inc.]

DR-XY35401

CEFAZEN Dr. Zen’s Research, Inc.

[Lloyd Labs., Inc.]

DR-XY36211

Cefadroxil 500 mg Capsule DURICEF*/

DURACEF*/

ULTRACEF*

[Bristol-Myers Squibb] Not available

locally

*This (or an alternative comparator product) should be purchased

from a well regulated market with stringent regulatory authority

i.e., from countries participating in the International Conference

on Harmonization (ICH).

LEXIPAD** Pharma 3 Co., Inc. [Korea

United Pharm. Inc. –

Korea]

DR-XY27116

**LEXIPAD may be considered as the alternative comparator

product once equivalence with DURICEF, DURACEF or

ULTRACEF (or an alternative comparator product) has been

satisfactorily demonstrated. [16-Dec-2015]

DROZID*** Gracio Med Phils., Inc.

[PT. Dexa Medica –

Indonesia]

DR-XY27305

***DROZID may be considered as the alternative comparator




125 mg/5 mL DURICEF*/ [Bristol-Myers Squibb] Not available

12

Powder for Oral

Suspension

DURACEF*/

ULTRACEF*

locally





DROZID* Gracio Med Phils., Inc.

[PT. Dexa Medica –

Indonesia]

DR-XY27708

*DROZID may be considered as the alternative comparator




250 mg/5 mL

Powder for Oral

Suspension

DURICEF*/

DURACEF*/

ULTRACEF*


locally





500 mg/5 mL

Powder for Oral

Suspension

DURICEF*/

DURACEF*/

ULTRACEF*


locally





Cefalexin

monohydrate

250 mg Capsule CEPOREX GlaxoSmithKline Phils.,

Inc. [Interphil Labs., Inc.]

DR-6865-L

500 mg Capsule CEPOREX GlaxoSmithKline Phils.,


DR-6866-L

100 mg/mL

Powder or

Granules for Oral

Suspension

CEPOREX GlaxoSmithKline Phils.,


DR-XY2819

125 mg/5 mL

Powder or

Granules for Oral

Suspension



DR-9606-L

250 mg/5 mL

Powder or

Granules for Oral

Suspension



DR-XY3906

Cefixime 100 mg Capsule TERGECEF United American Pharm’ls,

Inc. [Asian Antibiotics,

Inc.]

DR-XY15861

200 mg Capsule TERGECEF United American Pharm’ls, DR-XY16196

13


Inc.]

400 mg Capsule TERGECEF OD United American Pharm’ls,


Inc.]

DR-XY35403

20 mg/mL Powder

or Granules for

Oral Suspension

(Drops)

TERGECEF United American Pharm’ls,


Inc.]

DR-XY16858

100 mg/5 mL

Powder or

Granules for Oral

Suspension

TERGECEF United American Pharm’ls,


Inc.]

DR-XY16177

100 mg Chewable

Tablet

IXIME Lupin Phils., Inc. [Lupin

Ltd. – India]

DR-XY37512

Cefpodoxime proxetil 100 mg Tablet BANAN PL Asia Pacific Phils., Inc.

[Shanghai Sankyo

Pharm’ls Co. Ltd. – China]

DR-XY25947

BANAN* [Daiichi Sankyo] Not available

locally

*This should be purchased from a well regulated market with

stringent regulatory authority i.e., from countries participating in

the International Conference on Harmonization (ICH).

ORELOX** [Sanofi-Aventis] Not available

locally

**This should be purchased from a well regulated market with



40 mg/5 mL

Powder or

Granules for Oral

Suspension

ORELOX*** [Sanofi-Aventis] Not available

locally

***This should be purchased from a well regulated market with



200mg Capsule VANTIN (Tablet

form)

Pharmacia and Upjohn

(MAH in the US)

Not available

locally

50mg/mL Powder

for Suspension

VANTIN Pharmacia and Upjohn

(MAH in the US)

Not available

locally

Cefradine 125mg Powder for

Suspension

VELOSEF Bristol Myers-Squibb

(MAH in the USA)

Not available

locally

250mg Capsule VELOSEF Bristol Myers-Squibb

(MAH in the USA)

Not available

locally

500mg Capsule VELOSEF Bristol Myers-Squibb

(MAH in the USA)

Not available

locally

Cefuroxime axetil 250 mg Tablet ZINACEF GlaxoSmithKline Phils.,


Operations UK Ltd. –

DR-XY10186

14

United Kingdom]

ZINNAT Duncan Pharm’ls Phils.,



United Kingdom]

DR-XY18370

500 mg Tablet ZINACEF GlaxoSmithKline Phils.,



United Kingdom]

DR-XY18354




United Kingdom]

DR-XY18371

125 mg/5 mL

Powder or

Granules for Oral

Suspension




United Kingdom]

DR-XY14535

250 mg/5 mL

Powder or

Granules for Oral

Suspension




United Kingdom]

DR-XY23360

125 mg Powder or

Granules for Oral

Suspension


Inc. [Glaxo Operations UK

Ltd. – United Kingdom]

DR-XY43213

(in sachet)

250 mg Powder or

Granules for Oral

Suspension


Inc. [Glaxo Operations UK


DR-XY44381

(in sachet)

Celecoxib 100 mg Capsule CELEBREX Pfizer, Inc. [Pfizer

Pharm’ls LLC – Puerto

Rico]

DRP-2056

200 mg Capsule CELEBREX Pfizer, Inc. [Pfizer


Rico]

DRP-2052

400 mg Capsule CELEBREX 400 Pfizer, Inc. [Pfizer


Rico]

DRP-2057

Cetirizine

hydrochloride

10 mg Tablet VIRLIX GlaxoSmithKline Phils.,

Inc. [UCB Farchim SA –

Switzerland]

DR-XY13333

ZYRTEC Duncan Pharm’l Phils.,

Inc. [UCB Farchim SA –

Switzerland]

DR-XY19582

Chloramphenicol 250 mg Capsule CHLOROMYCE

TIN

Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2070

MICROMYCETI

N

Basic Pharm’l Corp.

[Lloyd Labs., Inc.]

DR-XY17398

RIELCETIN Jesriel Pharm’ls, Inc. DR-XY17624

15

[Lloyd Labs., Inc.]

500 mg Capsule CHLOROMYCE

TIN


Labs., Inc.]

DRP-2102

MICROMYCETI

N

Basic Pharm’l Corp.

[Lloyd Labs., Inc.]

DR-XY17156-

B

RIELCETIN Transcend Phils., Inc.

[Lloyd Labs., Inc.]

DR-XY15776

Chloramphenicol

palmitate

125 mg/5 mL Oral

Suspension

CHLOROMYCE

TIN


Labs., Inc.]

DRP-3411

PEDIACHLOR Pediatrica, Inc. [Amherst

Labs., Inc.]

DR-8773

Chlorphenamine

maleate

4 mg Tablet ANTAMIN Pascual Labs., Inc.


DR-2359

Chlorphenamine

maleate +

Phenylpropanolamine

hydrochloride

2 mg/25 mg

Tablet

NOXIFEN Interhealthcare Pharm’ls

Inc. [Lloyd Labs., Inc.]

DRP-935

(DR-XY30089)

Chlorphenamine

maleate +

Phenylpropanolamine

hydrochloride +

Paracetamol

2 mg/20 mg/500

mg Capsule

EXTRA

STRENGTH

SINUTAB

Johnson & Johnson

(Phils.), Inc. [Interphil

Labs., Inc.]

DR-XY2346

2 mg/20 mg/325

mg Capsule

VEDECONT Philippine Home Pharm’ls

[Lloyd Labs., Inc.]

DR-XY31368

1 mg/20 mg/325

mg Tablet

NAFARIN-A United American Pharm’ls,

Inc. [Amherst Labs., Inc.]

DR-5832

2 mg/25 mg/500

mg Tablet

DECOLGEN

FORTE

(For Export

Only)



DR-XY3624

Chlorphenamine

maleate +

Phenylephrine

hydrochloride +

Paracetamol

2 mg/10 mg/500

mg Tablet

DECOLGEN Westmont Pharm’ls, Inc.


DR-XY29386

DECOLGEN

FORTE


[PT. Medifarma Labs. –

Indonesia]

DR-XY41124

NEOZEP

FORTE

Myra Pharm’ls, Inc.


DR-XY29559

NEOZEP

FORTE

Myra Pharm’ls, Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY41125

BIOFLU Biomedis, Inc. [United

Labs., Inc.]

DR-XY34482

500 mcg/2.5

mg/125 mg per 5

mL Oral

Suspension

BIOFLU Biomedis, Inc. [Amherst

Labs., Inc.]

DR-XY37402

NEOZEP Myra Pharm’ls, Inc.


DR-XY42507

Chlorphenamine

maleate +

Dextromethorphan

2 mg/10 mg/25

mg/50 mg

Capsule

MUCOBRON

FORTE

Medi-Rx, Inc. [Medi-Rx,

Inc.]

DR-XY33008

16

hydrobromide +

Phenylpropanolamine

hydrochloride +

Guaifenesin

Chlorphenamine

maleate +

Dextromethorphan

hydrobromide +

Phenylpropanolamine

hydrochloride +

Guaifenesin +

Paracetamol

1 mg/15 mg/30

mg/50 mg/325 mg

Capsule

DYNATUSSIN Crisdy-Na Drug Corp.


Labs., Inc.]

DR-XY18308

Chlorphenamine

maleate +

Phenylpropanolamine

hydrochloride +

Salicylamide +

Paracetamol

2 mg/25 mg/150

mg/325 mg Tablet

YK ANTAMIN Pascual Labs., Inc.


DR-XY35895

Ciclosporin 25 mg

Softgel Capsule

SANDIMMUN

NEORAL


Inc. [R.P. Scherer GmbH


DR-XY19305

100 mg Softgel

Capsule

SANDIMMUN

NEORAL


Inc. [R.P. Scherer GmbH


DR-XY19307

Cilostazol 50 mg Tablet PLETAAL Otsuka (Phils.) Pharm’l,

Inc. [Korea Otsuka

Pharm’l Co., Ltd. – Korea]

DR-XY35875

100 mg Tablet PLETAAL Otsuka (Phils.) Pharm’l,

Inc. [Korea Otsuka

Pharm’l Co., Ltd. – Korea]

DR-XY35877

Cinnarizine 25 mg Tablet STUGERON Johnson & Johnson


Labs., Inc.]

DR-XY15279

STUGERON Johnson & Johnson

(Phils.), Inc. [Janssen

Korea Ltd. – Korea]

DR-XY34825

75 mg Capsule STUGERON

FORTE

Johnson & Johnson


Labs., Inc.]

DR-X548

STUGERON

FORTE

Johnson & Johnson



DR-XY40786

Ciprofloxacin

hydrochloride

250 mg Tablet CIPROBAY Bayer Phils., Inc. [Bayer


DR-XY35879

500 mg Tablet CIPROBAY Bayer Phils., Inc. [Bayer DR-XY34929

17


500 mg Extended-

Release Tablet

CIPROBAY XR Bayer Phils., Inc. [Bayer


DR-XY29458

1 g Extended-

Release Tablet

CIPROBAY XR Bayer Phils., Inc. [Bayer


DR-XY31382

Citicoline 500 mg Capsule SOMAZINE Patriot Pharm’ls Corp.

[Hizon Labs., Inc.]

DRP-432

500 mg Tablet CHOLINERV Therapharma, Inc.


DR-XY33845

Clarithromycin 250 mg Tablet KLARICID Abbott Labs. Phils., Inc.


Indonesia]

DR-XY39261

500 mg Tablet KLARICID Abbott Labs. Phils., Inc.


Indonesia]

DRP-4594

(DR-XY40032)

500 mg Extended-

Release Tablet

KLARICID OD Abbott Labs. Phils., Inc.

[Aesica Queenborough


DRP-1290

(DR-XY24276)

125 mg/5 mL

Powder or

Granules for Oral

Suspension

KLARICID Abbott Labs. Phils., Inc.


Indonesia]

DRP-1916

250 mg/5 mL

Powder or

Granules for Oral

Suspension

KLARICID Abbott Labs. Phils., Inc.


Indonesia]

DRP-2199

Clemastine fumarate 1 mg Tablet TAVEGYL Novartis Healthcare Phils.,

Inc. [Novartis Pharma

GmbH – Germany]

DR-4609

Clindamycin

hydrochloride

150 mg Capsule DALACIN C Pfizer, Inc. [PT. Pfizer


DRP-1954

300 mg Capsule DALACIN C Pfizer, Inc. [PT. Pfizer


DRP-1953

Clomifene citrate 50 mg Tablet CLOMID Sanofi-Aventis Phils., Inc.

[Patheon Pharm’ls, Inc. –

USA]

DR-5192

Clopidogrel bisulfate 75 mg Tablet PLAVIX Sanofi-Aventis Phils., Inc.

[Sanofi Winthrop Industrie

– France]

DRP-5643

(DR-XY24856)

300 mg Tablet PLAVIX Sanofi-Aventis Phils., Inc.


– France]

DR-XY37405

Cloxacillin sodium 250 mg Capsule PROSTAPHLIN- [Bristol-Myers Squibb Not available

18

A S.r.l. – Italy] locally

AXILLIN Foramen Products Corp.

[Lloyd Labs., Inc.]

DR-XY20552-

B

500 mg Capsule PROSTAPHLIN-

A


S.r.l. – Italy]

Not available

locally

VAMCLOXIL Vamsler Phils., Inc. [Lloyd

Labs., Inc.]

DR-XY20336-

B

Vamsler Phils., Inc. [Lloyd

Labs., Inc.]

DR-XY43659

125 mg/5 mL

Powder or

Granules for Oral

Suspension

MEDACLOX Sydenham Labs., Inc. DRP-939

(DR-XY20111)

250 mg/5 mL

Powder or

Granules for Oral

Suspension

Unbranded Ad-Drugstel Pharm’l

Labs., Inc.

DR-XY32596

Clozapine 25 mg Tablet LEPONEX Novartis Healthcare Phils.,

Inc. [Novartis Saglik –

Turkey]

DR-XY18407

100 mg Tablet LEPONEX Novartis Healthcare Phils.,


UK Ltd. – United

Kingdom]

DR-XY18403

Co-Amoxiclav

(Amoxicillin +

Clavulanic Acid)

250 mg/125 mg

Tablet

AUGMENTIN GlaxoSmithKline Phils.,


Plc. – United Kingdom]

DR-XY34001

500 mg/125 mg

Tablet




DR-XY14796

875 mg/125 mg

Tablet




DR-XY23156

125 mg/31.25 mg

per 5 mL Powder

for Oral

Suspension




DR-XY14007

200 mg/28.5 mg

per 5 mL Powder

for Oral

Suspension




DR-XY24085

250 mg/62.5 mg

per 5 mL Powder

for Oral

AUGMENTIN

DS




DR-XY14008

19

Suspension

400 mg/57 mg per

5 mL Powder for

Oral Suspension




DR-XY23806

600 mg/42.9 mg

per 5 mL Powder

for Oral

Suspension

AUGMENTIN

ES




DR-XY32295

Colchicine 500 mcg Tablet Unbranded Philusa Corp. [Surepharm

Services Ltd. – United

Kingdom]

DR-X2619

Cotrimazine

(Sulfadiazine +

Trimethoprim)

820 mg/180 mg

Tablet

TRIZINE

FORTE

Phoenix Pharm’ls, Inc.


Labs., Inc.]

DR-XY24055

205 mg/45 mg per

5 mL Oral

Suspension

TRIZINE Phoenix Pharm’ls, Inc.


Labs., Inc.]

DR-XY21983

Cotrimoxazole

(Trimethoprim +

Sulfamethoxazole)

400 mg/80 mg

Tablet

BACTRIM Roche (Phils.), Inc.


DR-75



C.V. – Mexico]

DR-XY40457

800 mg/160 mg

Tablet

BACTRIM

FORTE

Roche (Phils.), Inc.


DR-X2884

BACTRIM

FORTE



C.V. – Mexico]

DR-XY40456

200 mg/40 mg per

5 mL Oral

Suspension*



DR-XY8083

This may be used as the comparator product for generic Cotrimoxazole 400 mg/80 mg

per 5 mL Oral Suspension in the appropriate ratio.

Cyproterone acetate 50 mg Tablet ANDROCUR Bayer Phils., Inc.

[Delpharm Lille S.A.S. –

France]

DR-XY38963

Cyproterone acetate +

Ethinylestradiol

2 mg/35 mcg

Tablet

DIANE 35 Bayer Phils., Inc. [Schering

GmbH und Co.

Produktions KG –

Germany]

DR-XY6690

Dabigatran Etexilate 75mg Capsule PRADAXA Boehringer Ingelheim

(Phils.), Inc. [Boehringer

DR-XY35372

20



110mg Capsule PRADAXA Boehringer Ingelheim




DR-XY35371

150mg Capsule PRADAXA Boehringer Ingelheim




DR-XY39217

Desloratadine 5 mg Tablet AERIUS Merck Sharp & Dohme

(I.A.) Corp. [Schering-

Plough S.p.A. – Italy]

DR-XY27707

AERIUS Merck Sharp & Dohme


Plough Labo N.V. –

Belgium]

DR-XY39221

2.5 mg

Orodispersible

Tablet


(I.A.) Corp. [CIMA Labs.,

Inc. – USA]

DR-XY37393

5 mg

Orodispersible

Tablet


(I.A.) Corp. [CIMA Labs.,

Inc. – USA]

DR-XY37394

Dexamethasone 500 mcg Tablet

500 mcg Tablet

ORADEXON Aspen Phils., Inc.


DR-2540

DECILONE Westmont Pharm’ls, Inc.


DR-6271

750 mcg Tablet DRENEX United American Pharm’ls,


Inc.]

DR-6722

3 mg Tablet DRENEX United American Pharm’ls,


Inc.]

DR-7198

4 mg Tablet DECILONE

FORTE



DR-6518

Dextromethorphan

hydrobromide

5 mg Lozenge STREPSILS

DRY COUGH


[Reckitt Benckiser



DR-XY26127

STREPSILS

DRY COUGH


[Reckitt Benckiser

DRHR-1636

21



Diclofenac potassium

12.5 mg Tablet VOLTAREN

RAPID


Inc. [Novartis


DR-XY35520

25 mg Tablet CATAFLAM Novartis Healthcare Phils.,

Inc. [Novartis Urunleri –

Turkey]

DRP-4018

50 mg Tablet CATAFLAM Novartis Healthcare Phils.,


Turkey]

DR-XY29124

Diclofenac sodium 25 mg Enteric-

Coated Tablet

VOLTAREN Novartis Healthcare Phils.,


Turkey]

DR-XY28428

50 mg Enteric-

Coated Tablet

VOLTAREN

FORTE



Turkey]

DR-XY27769

100 mg Sustained-

Release Tablet

VOLTAREN SR Novartis Healthcare Phils.,


Stein AG – Switzerland]

DR-XY27795

Diethylcarbamazine

citrate

50 mg Tablet SUPATONIN* [Mitsubishi Tanabe

Pharma – Japan]

Not available

locally





FILARIZIDE** Blue Sky Trading Co., Inc.


Labs., Inc.]

DR-XY39906

(in blister pack)

FILARIZIDE** Blue Sky Trading Co., Inc.


Labs., Inc.]

DR-XY39907

(in plastic

bottle)

**FILARIZIDE may be considered as the alternative comparator

product once equivalence with SUPATONIN has been


Diloxanide furoate 500 mg Tablet DILFUR St. Martin Pharm’l Labs.,

Inc.

DRP-1127

(DR-XY33834)

125 mg/5 mL Oral

Suspension

DILFUR St. Martin Pharm’l Labs.,

Inc.

DRP-3697

Diltiazem

hydrochloride

30 mg Tablet DILZEM Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2100

(DR-XY12597)

22

60 mg Tablet DILZEM Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2010

(DR-XY12596)

90 mg Tablet DILZEM SA Pfizer, Inc. [Pfizer

Manufacturing

Deutschland GmbH –

Germany]

DRP-2012

120 mg Sustained-

Release Tablet

DILZEM OD Pfizer, Inc. [Pfizer

Manufacturing


Germany]

DRP-2009

180 mg Sustained-

Release Tablet

DILZEM SR Pfizer, Inc. [Pfizer

Manufacturing


Germany]

DRP-2011

Diosmin +

Hesperidin

450 mg/50 mg

Tablet

DAFLON 500 Servier Phils., Inc. [Les

Laboratoires Servier

Industries – France]

DR-XY12979

Diphenhydramine

Hydrochloride

25mg Capsule BENADRYL

AH

Johnson & Johnson

(Philippines), Inc.

[Interphil Laboratories,

Inc.]

DR-4620

50mg Capsule BENADRYL

AH

Johnson & Johnson

(Philippines), Inc.

[Interphil Laboratories,

Inc.]

DR-4621

Domperidone 10mg Tablet MOTILIUM Johnson & Johnson


Laboratories, Inc.]

DR-XY25762

MOTILIUM-M Johnson & Johnson



DR-XY40069

1mg/mL

(5mg/5mL)

Suspension

MOTILIUM Johnson & Johnson


Pharmaceutica – Belgium]

DR-X8545

Donepezil

hydrochloride

5 mg Tablet ARICEPT [Eisai Taiwan, Inc./Bora

Pharmaceuticals Co., Ltd –

Taiwan]

DR-XY33832

10 mg Tablet ARICEPT [Eisai Taiwan, Inc./Bora

Pharmaceuticals Co., Ltd –

Taiwan]

DR-XY33828

23 mg Tablet ARICEPT HI-Eisai Pharm’l, Inc.

[Eisai Co., Ltd. – Japan]

DR-XY42383

5 mg

Orodispersible

Tablet

ARICEPT

EVESS

HI-Eisai Pharm’l, Inc.

[Eisai Co., Ltd./Bushu

Pharm’ls Ltd. – Japan]

DR-XY35549

23

10 mg

Orodispersible

Tablet

ARICEPT

EVESS

HI-Eisai Pharm’l, Inc.

[Eisai Co., Ltd./Bushu

Pharm’ls Ltd. – Japan]

DR-XY35548

Doxycycline hyclate 100 mg Capsule VIBRAMYCIN Pfizer, Inc. [Pfizer


Australia]

DRP-2077

Duloxetine

hydrochloride

30 mg Capsule CYMBALTA Eli Lilly (Phils.), Inc. [Eli

Lilly and Co. – USA]

DR-XY31173

60 mg Capsule CYMBALTA Eli Lilly (Phils.), Inc. [Eli

Lilly and Co. – USA]

DR-XY41867

Dutasteride 500mcg Capsule AVODART GlaxoSmithKline

Philippines, Inc.

[GlaxoSmithKline

Pharmaceuticals S.A. –

Poland]

DR-XY29399

Enalapril maleate 5 mg Tablet RENITEC Merck Sharp & Dohme


& Dohme Ltd. – United

Kingdom]

DRP-4590

(DR-XY3886)

10 mg Tablet RENITEC Merck Sharp & Dohme



Kingdom]

DRP-4890

(DR-XY4212)

20 mg Tablet RENITEC Merck Sharp & Dohme



Kingdom]

DRP-4579

(DR-XY3885)

Entecavir 500 mcg Tablet BARACLUDE Zuellig Pharma Corp.

[Bristol-Myers Squibb Co.

– USA]

DR-XY31277

1 mg Tablet BARACLUDE Zuellig Pharma Corp.

[Bristol-Myers Squibb Co.

– USA]

DR-XY31276

Erlotinib

hydrochloride

25 mg Tablet TARCEVA Roche (Phils.), Inc.

[Kremers Urban Pharm’ls,

Inc. – USA]

DR-XY31270

TARCEVA Roche (Phils.), Inc. [F.

Hoffmann-La Roche Ltd. –

Switzerland]

DR-XY36901



Inc. – USA]

DR-XY31271



Switzerland]

DR-XY36900

TARCEVA Roche (Phils.), Inc. [Roche

S.p.A. – Italy]

DR-XY40838

24



Inc. – USA]

DR-XY31269



Switzerland]

DR-XY35967

TARCEVA Roche (Phils.), Inc. [Roche

S.p.A. – Italy]

DR-XY40837

Erythromycin

estolate

100 mg/mL Oral

Suspension

ILOSONE Aspen Phils., Inc.


DR-1773

125 mg/5 mL Oral

Suspension

ILOSONE Aspen Phils., Inc.


DR-1779

250 mg/5 mL Oral

Suspension

ILOSONE DS Aspen Phils., Inc.


DR-XY10241-

L

Erythromycin

ethylsuccinate

200 mg/5 mL

Powder or

Granules for Oral

Suspension

ERYTHROCIN A. Menarini Phils., Inc.


DR-785

EPERTOCYN Eadriex Pharm’ls Phils.,

Inc. [Lloyd Laboratories,

Inc.]

DRP-2237

(DR-XY12272)

Unbranded Pharex Health Corp.


DR-XY16473

400 mg/5 mL

Powder or

Granules for Oral

Suspension

ERYTHROCIN

DS

A. Menarini Phils., Inc.


DR-XY3293

ROMAXIN ProHealth Pharma Phils.,

Inc. [Lloyd Laboratories,

Inc.]

DR-XY13605

Erythromycin

stearate

250 mg Tablet ERYTHROCIN A. Menarini Phils., Inc.


DR-XY15612

ETRIOGAPE Pascual Labs., Inc.


DR-XY16271-

B



DR-XY16271

500 mg Tablet ERYTHROCIN A. Menarini Phils., Inc.


DR-X585

ETRIOGAPE Pascual Labs., Inc.


DR-XY16566-

B



DR-XY16566

Escitalopram oxalate 5 mg Tablet LEXAPRO Metro Drug, Inc. [H.

Lunbeck A/S – Denmark]

DR-XY29577

10 mg Tablet LEXAPRO Metro Drug, Inc. [H.


DR-XY29575

25



DR-XY29576



DR-XY29578

Esomeprazole

magnesium trihydrate

10 mg Granules

for Oral

Suspension

NEXIUM AstraZeneca Pharm’ls


AB – Sweden]

DR-XY35546

20 mg Enteric-

coated Tablet



AB – Sweden]

DR-XY27082

40 mg Enteric-

coated Tablet



AB – Sweden]

DR-XY27081

Estramustine 140mg Capsule EMCYT/

ESTRACYT

[Pharma and

Upjohn/Pfizer]

Not available

locally

Etoricoxib 30 mg Tablet ARCOXIA Merck Sharp & Dohme


S.A. – Spain]

DRP-4079

60 mg Tablet ARCOXIA Merck Sharp & Dohme


S.A. – Spain]

DRP-4080

90 mg Tablet ARCOXIA Merck Sharp & Dohme


S.A. – Spain]

DRP-3437

120 mg Tablet ARCOXIA AC Merck Sharp & Dohme


S.A. – Spain]

DRP-4081

Ezetimibe 10 mg Tablet EZETROL Merck Sharp & Dohme


Plough Products Ltd. –

USA]

DR-XY28718

Febuxostat 10 mg Tablet FEBURIC Teijin Pharma Ltd. (MAH

in Japan)

Not available

locally

20 mg Tablet FEBURIC Teijin Pharma Ltd. (MAH

in Japan)

Not available

locally

40 mg Tablet FEBURIC Teijin Pharma Ltd. (MAH

in Japan)

Not available

locally

ULORIC Takeda Pharm’ls America,

Inc. (MAH in the USA)

Not available

locally

80 mg Tablet ULORIC Takeda Pharm’ls America,

Inc. (MAH in the USA)

Not available

locally

ADENURIC Menarini Int’l Operations

Luxembourg S.A. [Patheon

France – France or

Menarini-Von Heyden

GmbH – Germany]

Not available

locally

26

120 mg Tablet ADENURIC Menarini Int’l Operations

Luxembourg S.A. [Patheon

France – France or

Menarini-Von Heyden

GmbH – Germany]

Not available

locally

Felodipine 2.5 mg Extended-

release Tablet

PLENDIL ER AstraZeneca Pharm’ls



DR-XY24163

5 mg Extended-

release Tablet




DR-XY16801

10 mg Extended-

release Tablet




DR-XY16802

Fenofibrate 67 mg Micronized

Capsule

LIPANTHYL Abbott Products Phils., Inc.

[Recipharm Fontaine –

France]

DR-XY26190

200 mg

Micronized

Capsule

FIBRAFEN

200M

Abbott Products Phils., Inc.

[Recipharm Parets S.L. –

Spain]

DRP-125

250 mg Sustained-

Release Capsule

LIPWAY SR The Cathay Drug Co., Inc.


Labs., Inc.]

DR-XY28840

145 mg Tablet LIPANTHYL

NT


[Fournier Labs. Ireland

Ltd. – Ireland]

DR-XY33285

160 mg Tablet LIPANTHYL

SUPRA


[Recipharm Fontaine –

France]

DRP-122

160 mg Capsule FENOFLEX LR Imperial, Inc. [Amherst

Labs., Inc.]

DR-XY32213

Ferrous sulfate 325 mg Tablet Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-5056

250 mg Sustained-

release Capsule

FEOSOL A. Menarini Phils., Inc.


Labs., Inc.]

DR-X556

310 mg Sustained-

release Capsule

SORBIFER

DURULES

Multicare Pharm’l Phils.,

Inc. [Hizon Labs., Inc.]

DR-XY25098

Ferrous fumarate 500 mg Tablet ARFERATE Optaderm Pharma, Inc.


DR-XY27478

Fexofenadine HCl 120mg Tablet TELFAST Sanofi-Aventis Philippines,

Inc. [PT Aventis Pharma –

Indonesia]

DRP-2109

180mg Tablet TELFAST Sanofi-Aventis Philippines, DRP-2108

27


Indonesia]

Finasteride 1 mg Tablet PROPECIA Merck Sharp & Dohme

(I.A.) Corp. [MSD Int’l

GmbH LLC – Puerto Rico]

DR-XY25359

5 mg Tablet PROSCAR Merck Sharp & Dohme

(I.A.) Corp. [MSD Int’l

GmbH LLC – Puerto Rico]

DR-XY16541

Flucloxacillin sodium 250 mg Capsule STAFLOXIN Westmont Pharm’ls, Inc.


DR-XY16012

500 mg Capsule STAFLOXIN Westmont Pharm’ls, Inc.


DR-XY16013

Flucloxacillin

magnesium

125 mg/5 mL

Powder or

Granules for Oral

Suspension

STAFLOXIN Westmont Pharm’ls, Inc.


DR-XY26295

Fluconazole 50mg Capsule DIFLUCAN Pfizer, Inc. [Pfizer Pty.

Ltd. – Australia]

DRP-1965

150mg Capsule DIFLUCAN Pfizer, Inc. [Pfizer Pty.

Ltd. – Australia]

DRP-1964

200mg Capsule DIFLUCAN Pfizer, Inc. [Pfizer Pty.

Ltd. – Australia]

DRP-1963

Flunarizine

hydrochloride

5 mg Capsule SIBELIUM Johnson & Johnson

(Phils.), Inc. [Janssen-Cilag

S.p.A. – Italy]

DR-XY29450

SIBELIUM Johnson & Johnson



DR-XY38084

Fluoxetine (as

Hydrochloride)

20mg Capsule PROZAC Eli Lilly (Philippines), Inc.

[Patheon France – France]

DR-XY13199

Folic Acid 5 mg Capsule FOLART Folares Pharm’ls, Inc.

[Lloyd Labs., Inc.]

DR-XY23299

5 mg Tablet ENHANSID Interhealthcare Pharm’ls

Inc. [Sunward Pharm’l Pte.

Ltd. – Singapore]

DRP-099

(DR-XY26552)

FOLATE JRalph Pharm’ls, Inc.

[Hizon Labs., Inc.]

DRP-1677

MAXIFOL-5000 Pharma Nutria N.A., Inc.

[Hizon Labs., Inc.]

DR-XY34053

Fosinopril sodium 10 mg Tablet BP NORM Westmont Pharm’ls, Inc.


DR-XY37250

20 mg Tablet BP NORM Westmont Pharm’ls, Inc. DR-XY37046

28


Furosemide 20 mg Tablet FRUSEMA L.R. Imperial, Inc.


DR-X887

40 mg Tablet LASIX Sanofi-Aventis Phils., Inc.

[Handok Pharm’l Co. Ltd.

– Korea]

DR-1110

FRUSEMA L.R. Imperial, Inc.


DR-X886

Gabapentin 100 mg Capsule NEURONTIN Pfizer, Inc. [Pfizer


Rico]

DRP-1993

300 mg Capsule NEURONTIN Pfizer, Inc. [Pfizer


Rico]

DRP-1967

400 mg Capsule NEURONTIN Pfizer, Inc. [Pfizer


Rico]

DRP-1988

600 mg Tablet NEURONTIN Pfizer, Inc. [Pfizer


Rico]

DRP-3447

Gefitinib 250 mg Tablet IRESSA AstraZeneca Pharm’ls



DR-XY28953

Gemfibrozil 300 mg Capsule LOPID Pfizer, Inc. [PT. Bayer

Indonesia Tbk. –

Indonesia]

DRP-2004

(DR-XY2110)

600 mg Tablet LOPID Pfizer, Inc. [Pfizer


Australia]

DRP-2003

(DR-XY16208)

900 mg Tablet LOPID OD Pfizer, Inc. [Pfizer

Manufacturing


Germany]

DRP-2105

(DR-XY15309)

Gestodene +

Ethinylestradiol

75mcg/30mcg

Tablet

GYNERA Bayer Philippines, Inc.

[Schering do Brasil

Quimica e Farmaceutica

Ltda – Brazil]

DR-XY25163

Glibenclamide 2.5 mg Tablet SEMI-

EUGLUCON


[Patheon Italia S.p.A. –

Italy]

DR-7919

5 mg Tablet DAONIL Sanofi-Aventis Phils., Inc. DR-1712

29

[Handok Pharm’ls Co. Ltd.

– Korea]

DAONIL Sanofi-Aventis Phils., Inc.

[PT. Aventis Pharma


DRP-087

EUGLUCON Roche( Phils.), Inc.


DR-1713

Gliclazide 80 mg Tablet DIANORM Merck, Inc. (Phils.)

[Alphapharm Pty. Ltd. –

Australia]

DR-XY29814

30 mg Modified-

Release Tablet

DIAMICRON

MR

Servier Phils., Inc. [Les



DR-XY25281

60 mg Modified-

Release Tablet

DIAMICRON

MR

Servier Phils., Inc. [Les



DR-XY38522

80 mg Modified-

Release Tablet

DIAMICRON Servier Phils., Inc. [Les



DR-X626

Glimepiride 1 mg Tablet SOLOSA Sanofi-Aventis Phils., Inc.

[Sanofi-Aventis S.p.A. –

Italy]

DRP-006

2 mg Tablet SOLOSA Sanofi-Aventis Phils., Inc.


Italy]

DRP-007

(DR-XY24736)

3 mg Tablet SOLOSA Sanofi-Aventis Phils., Inc.


Italy]

DRP-008

Glimepiride +

Metformin

hydrochloride

1 mg/250 mg

Tablet

SOLOSAMET Sanofi-Aventis Phils., Inc.


– Korea]

DR-XY33865

2 mg/500 mg

Tablet

SOLOSAMET Sanofi-Aventis Phils., Inc.


– Korea]

DR-XY33866

2 mg/500 mg

Sustained-Release

Tablet

SOLOSAMET

SR

Sanofi-Aventis Phils., Inc.


– Korea]

DR-XY39671

Glipizide 5 mg Tablet MINIDIAB Pfizer, Inc. [Pfizer Italia

S.r.l. – Italy]

DR-XY31426

5 mg Controlled-

Release Tablet

MINIDIAB OD Pfizer, Inc. [Pfizer


DRP-3420

(DR-XY29647)

30

Rico]

10 mg Controlled-

Release Tablet

MINIDIAB OD Pfizer, Inc. [Pfizer


Rico]

DRP-3621

(DR-XY29646)

Guaifenesin

200 mg Softgel

Capsule

ROBITUSSIN Pfizer, Inc. [Catalent


Australia]

DR-XY28913

600 mg Extended-

Release Tablet

MUCINEX Zuellig Pharma Corp.

[Reckitt Benckiser, LLC –

USA]

DR-XY39924

Haloperidol 2 mg Tablet HALDOL Johnson & Johnson Phils.,

Inc. [Lusomedicamenta-

Sociedade Tecnica

Farmaceutica SA –

Portugal]

DR-XY23387

5 mg Tablet HALDOL Johnson & Johnson Phils.,


Sociedade Tecnica

Farmaceutica SA –

Portugal]

DR-6630

SERENACE Pfizer, Inc. [Piramal

Healthcare UK Ltd. –

United Kingdom]

DRP-1933

10 mg Tablet HALDOL Johnson & Johnson Phils.,


Sociedade Tecnica

Farmaceutica SA –

Portugal]

DR-X6733

20 mg Tablet SERENACE Pfizer, Inc. [Piramal


United Kingdom]

DRP-1975

Hydrochlorothiazide 12.5 mg Tablet HYTAZ Therapharma, Inc.


DR-XY30440

25 mg Tablet HYTAZ Therapharma, Inc.


DR-XY30255

Hydroxychloroquine

sulfate

200 mg Tablet PLAQUENIL Sanofi-Aventis Phils., Inc.

[Sanofi-Synthelabo Ltd. –

United Kingdom]

DR-XY20092

Hydroxyurea 500mg Capsule HYDREA [Bristol-Myers Squibb

Company]

Not available

locally

Hyoscine

butylbromide

10 mg Tablet BUSCOPAN Boehringer Ingelheim


Labs., Inc.]

DR-1760

31

BUSCOPAN Boehringer Ingelheim

(Phil.), Inc. [PT.



DR-XY41205

Hyoscine

butylbromide +

Paracetamol

10 mg/500 mg

Tablet

BUSCOPAN

PLUS


(Phil.), Inc. [PT.



DRP-3039

(DR-XY1774)

Ibandronic Acid 50 mg Tablet BONDRONAT Roche (Phils.), Inc. [F.


Switzerland]

DR-XY31246

BONDRONAT Roche (Phils.), Inc.


C.V. – Mexico]

DR-XY42448

150 mg Tablet BONVIVA Nycomed Phils. [F.


Switzerland]

DR-XY39024

Ibuprofen 200 mg Tablet MEDICOL Myra Pharm’ls, Inc.


DR-XY24958

MIDOL A. Menarini Philippines,

Inc. [Swisspharma

Research Labs., Inc.]

DR-XY30477

400 mg Tablet MEDICOL I-400 Myra Pharm’ls, Inc.


DR-XY24952

MIDOL A. Menarini Philippines,

Inc. [Swisspharma

Research Labs., Inc.]

DR-XY32216

600 mg Tablet BRUFEN Abbott Labs. Phils., Inc.


Indoneisa]

DR-XY40727

200 mg Softgel

Capsule

ADVIL Pfizer, Inc. [Catalent

Australia Pty. Ltd –

Australia]

DR-XY32938

400 mg Softgel

Capsule

MEDICOL

ADVANCE 400



DR-XY41760

100 mg/2.5 mL

Oral Suspension

DOLAN FP Pediatrica, Inc. [United

Labs., Inc.]

DR-XY36588

100 mg/5 mL Oral

Suspension

DOLAN FP Pediatrica, Inc. [Amherst

Labs., Inc.]

DR-XY23908

200 mg/5 mL Oral

Suspension

DOLAN FP

FORTE

Pediatrica, Inc. [Amherst

Labs., Inc.]

DR-XY30816

Ibuprofen +

Paracetamol

200 mg/325 mg

Tablet

ALAXAN Therapharma, Inc. [United

Labs., Inc.]

DR-2318

ALAXAN United Labs., Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY37938

MUSKELAX United Home Products DR-XY13304

32


RESTOLAX EuroHealth Care


Labs., Inc.]

DR-XY24007

400 mg/325 mg

Tablet

RESTOLAX

FORTE

EuroHealth Care


Labs., Inc.]

DRP-2626

(DR-XY28952)

200 mg/325 mg

Capsule

ALAXAN FR Therapharma, Inc. [United

Labs., Inc.]

DR-XY27687

200 mg/325 mg

Capsule

ALAXAN FR United Labs., Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY37939

Imatinib mesilate 100 mg Tablet GLIVEC Novartis Healthcare Phils.,



DR-XY30156

100 mg Tablet GLIVEC Novartis Healthcare Phils.,


Produktions GmbH –

Germany]

DR-XY30156

400 mg Tablet GLIVEC Novartis Healthcare Phils.,



DR-XY30155

Indinavir sulfate 400 mg Capsule CRIXIVAN Merck Sharp & Dohme


& Dohme Corp. – USA]

DR-XY23211

Irbesartan 150 mg Tablet APROVEL Sanofi-Aventis Phils., Inc.


– France]

DRP-5716

(DR-XY24039)

300 mg Tablet APROVEL Sanofi-Aventis Phils., Inc.


– France]

DRP-5715

(DR-XY24038)

Irbesartan +

Hydrochlorothiazide

150 mg/12.5 mg

Tablet

CO-APROVEL Sanofi-Aventis Phils., Inc.


– France]

DRP-001

300 mg/12.5 mg

Tablet



– France]

DRP-002

300 mg/25 mg

Tablet



– France]

DRP-5717

(DR-XY34372)

Isoniazid 100 mg Tablet Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-5058


Labs., Inc.]

DR-X9633

33

Isosorbide

mononitrate

20 mg Tablet ELANTAN 20 GlaxoSmithKline Phils.,

Inc. [Schwarz Pharma AG

– Germany]

DR-XY6943

ELANTAN 20 GlaxoSmithKline Phils.,

Inc. [Aesica Pharm’ls

GmbH – Germany]

DR-XY6943

30 mg Tablet IMDUR

DURULES

AstraZeneca Pharm’ls


Pharm’l Co., Ltd. – China]

DR-XY25446

40 mg Tablet ELANTAN 40 GlaxoSmithKline Phils.,


– Germany]

DR-XY6944

ELANTAN 40 GlaxoSmithKline Phils.,


GmbH – Germany]

DR-XY6944

60 mg Extended-

Release Tablet

IMDUR

DURULES

AstraZeneca Pharm’ls



DR-XY23150

ELANTAN GlaxoSmithKline Phils.,

Inc. [Schwarz Pharma

Manufacturing, Inc. –

USA]

DR-XY27369

50 mg Extended-

Release Capsule

ELANTAN GlaxoSmithKline Phils.,


– Germany]

DR-XY7878

Isosorbide dinitrate 5 mg Tablet

(Oral/Sublingual)

ISOKET GlaxoSmithKline Phils.,


GmbH – Germany]

DR-XY6936

5 mg Sublingual

Tablet

ISORDIL Pfizer, Inc. [Interphil

Labs., Inc.]

DR-XY6510


Labs., Inc.]

DR-XY39155

10 mg Tablet

(Oral/Sublingual)



GmbH – Germany]

DR-XY6937

10 mg Tablet ISORDIL Pfizer, Inc. [Interphil

Labs., Inc.]

DR-XY6511


Labs., Inc.]

DR-XY38979

20 mg Sustained-

Release Tablet



GmbH – Germany]

DR-XY6938

40 mg Sustained-

Release Tablet



GmbH – Germany]

DR-XY6939

Isotretinoin 10mg Capsule ROACCUTANE Roche (Philippines), Inc.

[F. Hoffman La Roche Ltd.

DR-XY2847

34

– Germany]

Ivabradine 5mg Tablet CORALAN Servier Philippines, Inc.

[Les Laboratoires Servier


DR-XY32013

7.5mg Tablet CORALAN Servier Philippines, Inc.

[Les Laboratoires Servier


DR-XY32012

Ketotifen fumarate 1 mg Tablet ZADEC Novartis Healthcare Phils.,


UK Ltd. – United

Kingdom]

DR-XY25657

2 mg Modified-

Release Tablet

ZADEC SRO Novartis Healthcare Phils.,

Inc. [Novartis Farma

S.p.A. – Italy]

DRP-4573

(DR-XY15842)

ZADITEN SRO Sandoz Phils. Corp

[Novartis Farma S.p.A. –

Italy]

DR-XY16874

Lacidipine 2 mg Tablet LACIPIL GlaxoSmithKline Phils.,


– Spain]

DR-XY16826

4 mg Tablet LACIPIL GlaxoSmithKline Phils.,


– Spain]

DR-XY16827

6 mg Tablet LACIPIL GlaxoSmithKline Phils.,


– Spain]

DR-XY29222

Lamotrigine 25 mg Dispersible

Tablet

LAMICTAL GlaxoSmithKline Phils.,


Pharm’ls S.A. – Poland]

DR-XY20983

50 mg Tablet LAMICTAL GlaxoSmithKline Phils.,



DR-XY17652

100 mg Tablet LAMICTAL GlaxoSmithKline Phils.,



DR-XY17653

Levetiracetam 250 mg Film-

Coated Tablet

KEPPRA GlaxoSmithKline Phils.,

Inc. [UCB Pharma S.A. –

Belgium]

DR-XY29934

500 mg Film-

Coated Tablet



Belgium]

DR-XY29131

1 g Film-Coated

Tablet



Belgium]

DR-XY29122

Levocetirizine

Hydrochloride

5mg Tablet XYZAL GlaxoSmithKline

Philippines, Inc. [UCB

Farchim S.A. –

DR-XY28008

35

Switzerland]

Levodopa +

Carbidopa

100 mg/25 mg

Tablet

SINEMET Merck Sharp & Dohme

(I.A.) Corp. [Mylan

Pharm’ls Inc. –USA]

DR-XY14285

250 mg/25 mg

Tablet

SINEMET Merck Sharp & Dohme


& Dohme (Australia) Pty.

Ltd. – Australia]

DR-9001

Levofloxacin

hemihydrate

250 mg Tablet LEVOX Westmont Pharm’ls, Inc.


DR-XY23654

FLOXEL United American Pharm’ls,


DR-XY24335



DR-XY23653



DR-XY24334



DR-XY32085



DR-XY32172

Levonorgestrel +

Ethinylestradiol

125 mcg/30 mcg

Tablet with

Ferrous Fumarate

75 mg Tablet

TRUST PILL DKT Phils., Inc. [Pond’s

Chemical Thailand R.O.P.

– Thailand]

DRP-336 (DR-

XY21773)

150 mcg/30 mcg

Tablet

SEIF Bayer Phils., Inc. [Schering

do Brasil – Brazil]

DR-XY8804

NORDETTE Pfizer, Inc. [Wyeth Medica

Ireland Ltd. – Ireland]

DR-XY23241

250 mcg/50 mcg

Tablet

NORDIOL 21 Pfizer, Inc. [Wyeth Medica


DR-XY22610

50 mcg/30 mcg

Tablet; 75 mcg/40

mcg Tablet; 125

mcg/30 mcg

Tablet

TRINORDIOL Pfizer, Inc. [Wyeth Medica


DR-XY3927

LOGYNON Bayer Phils., Inc. [Bayer

Weimar GmbH und Co.

KG – Germany]

DR-XY9421

Levothyroxine

sodium

25 mcg Tablet THYRAX

DUOTAB

Aspen Phils., Inc. [N.V.

Organon – Netherlands]

DR-XY21847

50 mcg Tablet ELTROXIN Aspen Phils., Inc. [Aspen


Germany]

DR-9961

100 mcg Tablet ELTROXIN Aspen Phils., Inc. [Aspen


Germany]

DR-9962

THYRAX

DUOTAB



DR-XY21848

150 mcg Tablet THYRAX

DUOTAB



DR-XY21849

36

Linezolid 600 mg Tablet ZYVOX Pfizer, Inc. [Pfizer

Pharmaceuticals LLC –

Puerto Rico]

DR-XY27448

100 mg/5 mL

Powder for Oral

Suspension

ZYVOX Pfizer, Inc. [Pfizer

Pharmaceuticals LLC –

Puerto Rico]

DR-XY27447

ZYVOX Pfizer, Inc. [Pharmacia &

Upjohn - USA]

DR-XY38947

Loperamide

hydrochloride

2 mg Capsule

LORMIDE United Home Products


DR-X6084

IMODIUM Johnson & Johnson Phils.,


DR-XY14916

DIATABS Biomedis, Inc. [United

Labs., Inc.]

DR-XY24964

2 mg Tablet LOMOTIL Johnson & Johnson Phils.,


DR-XY27914

Lopinavir + Ritonavir 200 mg/50 mg

Tablet

ALUVIA Abbott Labs. Phils., Inc.


– Germany]

DR-XY35003

Loratadine 10 mg Tablet ALLERTA United American Pharm’ls,


DR-XY29925

CLARITIN Organon Phils., Inc.

[Schering-Plough Labo

N.V. – Belgium]

DRP-3596

10 mg Orally

Disintegrating

Tablet

CLARITIN

REDITABS

Organon Phils., Inc.

[Catalent UK Swindon

Zydis Ltd. – United

Kingdom]

DR-XY43946

Losartan potassium 50 mg Tablet COZAAR Merck Sharp & Dohme



Kingdom]

DR-XY21196

100 mg Tablet COZAAR Merck Sharp & Dohme



Kingdom]

DR-XY28142

Losartan potassium +

Hydrochlorothiazide

50 mg/12.5 mg

Tablet

HYZAAR Merck Sharp & Dohme



Kingdom]

DR-XY24847

100 mg/12.5 mg

Tablet

HYZAAR Merck Sharp & Dohme



DR-XY34041

37

Kingdom]

100 mg/25 mg

Tablet

HYZAAR DS Merck Sharp & Dohme



Kingdom]

DR-XY27120

Lynestrenol 500mg Tablet EXLUTON Merck Sharp & Dohme

(I.A.) Corporation. [N.V.


DR-XY18077

Mebendazole 100 mg Tablet ANTIOX Johnson & Johnson Phils.,

Inc. [Xian-Janssen Pharm’l

Ltd. – China]

DR-XY19304

500 mg Chewable

Tablet

ANTIOX

(Chocolate

Flavor)

Johnson & Johnson Phils.,


DR-XY20154

ANTIOX Johnson & Johnson Phils.,

Inc. [Janssen Korea Ltd. –

Korea]

DR-XY40801

20 mg/mL (100

mg/5 mL) Oral

Suspension


Inc. [Janssen

Pharmaceutica N.V. –

Belgium]

DR-X3594



DR-XY15649

50 mg/mL Oral

Suspension



DR-XY20534

Mecobalamin 500 mcg Tablet METHYCOBAL HI-Eisai Pharm’l, Inc.


DR-XY14117

Mefenamic Acid 250 mg Capsule PONSTAN SF Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2074

(DR-XY29076)

500 mg Capsule PONSTAN SF Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2099

(DR-XY20198)

500 mg Tablet PONSTAN Pfizer, Inc. [PT. Pfizer


DRP-2092

50 mg/5 mL Oral

Suspension

PONSTAN Pfizer, Inc. [Interphil

Labs., Inc.]

DRP-2075

Mefloquine

hydrochloride

250 mg Tablet LARIAM Roche Phils., Inc. [F.


Switzerland]

DR-XY16323

Megestrol acetate 40 mg Tablet Unbranded Marketlink Int’l Corp.

[Pharmachemie B.V. –

Netherlands]

DR-XY22677

38

MEGACE Par Pharm (MAH in the

USA)

Not available

locally

160 mg Tablet MEGACE Zuellig Pharma Corp.

[Haupt Pharma

Regensburg GmbH –

Germany]

DR-XY7203

MEGACE Swedish Orphan Biovitrum

(MAH in EU)

Not available

locally

MEGAPLEX Pacific Healthcare Phils.,

Inc. [Teva Czech Industries

s. r. o. – Czech Republic]

DR-XY22884

Meloxicam 7.5 mg Tablet MOBIC Boehringer Ingelheim


Labs., Inc.]

DR-XY22460

MOBIC Boehringer Ingelheim

(Phil.), Inc. [PT.



DR-XY41948

15 mg Tablet MOBIC Boehringer Ingelheim




DR-XY23446

MOBIC Boehringer Ingelheim

(Phil.), Inc. [PT.



DR-XY41947

Memantine

hydrochloride

10 mg Tablet ABIXA Metro Drug, Inc.

[Rottendorf Pharma GmbH

– Germany]

DR-XY30750

20 mg Tablet ABIXA Metro Drug, Inc.

[Rottendorf Pharma GmbH

– Germany]

DR-XY36194

Mercaptopurine 50 mg Tablet PURI-NETHOL Aspen Phils., Inc. [Excella

GmbH – Germany]

DR-272

Metformin

hydrochloride

500 mg Tablet GLUCOPHAGE Merck, Inc. [PT. Merck

Tbk. – Indonesia]

DR-XY33613

850 mg Tablet GLUCOPHAGE

FORTE

Merck, Inc. [PT. Merck

Tbk. – Indonesia]

DR-XY32220

1 g Tablet GLUCOPHAGE Merck, Inc. [Merck Sante

S.A.S. – France]

DR-XY27551

500 mg Extended-

Release Tablet

GLUCOPHAGE

XR

Merck, Inc. [Merck Sante

S.A.S. – France]

DR-XY32414

750 mg Extended-

Release Tablet

GLUCOPHAGE

XR

Merck, Inc. [Merck Sante

S.A.S. – France]

DR-XY35311

1 g Extended- GLUCOPHAGE Merck, Inc. [Merck Sante DR-XY40758

39

Release Tablet XR S.A.S. – France]

Metformin

hydrochloride +

Glibenclamide

250 mg/1.25 mg

Tablet

GLUCOVANCE Merck, Inc. [Merck Sante

S.A.S. – France]

DR-XY28383

500 mg/2.5 mg

Tablet


S.A.S. – France]

DR-XY28382

500 mg/5 mg

Tablet


S.A.S. – France]

DR-XY28255

1 g/5 mg Tablet GLUCOVANCE Merck, Inc. [Merck Sante

S.A.S. – France]

DR-XY41213

400 mg/2.5 mg

Tablet

EUGLO PLUS Roche Phils., Inc. [Patheon

Italia S.p.A. – Italy]

DR-XY31288

Methylergometrine

maleate

125 mcg Tablet METHERGIN Novartis Healthcare Phils.,


GmbH – Germany]

DRP-1979

(DR-4596)

Metoprolol Succinate 23.75mg

Controlled-Release

Tablet

BETAZOK AstraZeneca

Pharmaceuticals (Phils.),

Inc. [AstraZeneca AB –

Sweden]

DR-XY29023

47.5mg Extended-

/Controlled-

Release Tablet

TOPROL-XL [AstraZeneca] Not available

locally

95mg Controlled-

Release Tablet

BETAZOK AstraZeneca


Inc. [AstraZeneca AB –

Sweden]

DR-XY12973

Metoprolol Tartrate 50mg Tablet BETALOC AstraZeneca


Inc. [AstraZeneca

Pharmaceutical Co. Ltd. –

China]

DR-X1848

100mg Tablet BETALOC AstraZeneca


Inc. [AstraZeneca

Pharmaceutical Co. Ltd. –

China]

DR-X1812

Mirtazapine 15 mg

Orodispersible

Tablet

REMERON

SOLTAB

Merck Sharp & Dohme

(I.A.) Corp. [Cephalon,

Inc. – USA]

DR-XY29233

30 mg

Orodispersible

Tablet

REMERON

SOLTAB

Merck Sharp & Dohme


Inc. – USA]

DR-XY29236

40

45 mg

Orodispersible

Tablet

REMERON

SOLTAB

Merck Sharp & Dohme


Inc. – USA]

DR-XY29235

15 mg Tablet REMERON [N.V. Organon –

Netherlands]

Not Available

Locally


Netherlands]

Not Available

Locally


Netherlands]

Not Available

Locally

Montelukast sodium 4 mg Chewable

Tablet

SINGULAIR Merck Sharp & Dohme



Kingdom]

DR-XY27122

5 mg Chewable

Tablet




Kingdom]

DR-XY24156

10 mg Film-

Coated Tablet




Kingdom]

DR-XY24157

Morphine sulfate 10 mg Modified-

Release Tablet

MST

CONTINUS

Mundipharma Distribution

GmbH (Phil. Branch)

[Bard Pharm’ls Ltd. –

United Kingdom]

DR-XY13020

30 mg Modified-

Release Tablet

MST

CONTINUS


GmbH (Phil. Branch)


United Kingdom]

DR-XY13019

60 mg Modified-

Release Tablet

MST

CONTINUS


GmbH (Phil. Branch)


United Kingdom]

DR-XY13021

100 mg Modified-

Release Tablet

MST

CONTINUS


GmbH (Phil. Branch)


United Kingdom]

DR-XY13022

Naproxen 250 mg Tablet NAPROSYN

LLE

Roche (Phils.), Inc. [Roche

Farma S.A. – Spain]

DR-XY16667

500 mg Tablet NAPROSYN

LLE FORTE

Roche (Phils.), Inc. [Roche

Farma S.A. – Spain]

DR-XY16668

41

Naproxen sodium 275 mg Tablet FLANAX Roche (Phils.), Inc.


DR-X7096

550 mg Tablet FLANAX

FORTE



DR-XY2914

Nebivolol

hydrochloride

2.5 mg Tablet NEBICAR OEP Phils., Inc. [Micro

Labs Ltd. – India]

DR-XY36295

5 mg Tablet NEBICAR OEP Phils., Inc. [Micro

Labs Ltd. – India]

DR-XY31941

NEBILET A. Menarini Phils., Inc.

[Berlin-Chemie AG –

Germany]

DR-XY36223

LOBIVON Transfarma Phils., Inc.

[Berlin-Chemie AG –

Germany]

DR-XY36226

Nifedipine 5mg Capsule ADALAT Bayer Philippines, Inc.

[Bayer Pharma AG –

Germany]

DRP-639

10mg Capsule ADALAT Bayer Philippines, Inc.


Germany]

DRP-618

20mg Tablet ADALAT

RETARD

Bayer Philippines, Inc.


Germany]

DR-XY455

20mg Prolonged-

Release Tablet

ADALAT GITS

20



Germany]

DR-XY25315

30mg Prolonged-

Release Tablet

ADALAT GITS

30



Germany]

DR-XY26959

60mg Prolonged-

Release Tablet

ADALAT GITS

60



Germany]

DR-XY27180

Olanzapine 5 mg Tablet ZYPREXA Eli Lilly [Lilly del Caribe,

Inc. – Puerto Rico]

DR-XY22855

10 mg Tablet ZYPREXA Eli Lilly [Lilly del Caribe,


DR-XY22856

5 mg

Orodispersible

Tablet

ZYPREXA

ZYDIS

Eli Lilly [Catalent UK

Swindon Zydis Ltd. –

United Kingdom]

DR-XY37273

10 mg

Orodispersible

Tablet

ZYPREXA

ZYDIS

Eli Lilly [Catalent UK


United Kingdom]

DR-XY37455

Olmesartan

medoxomil

10 mg Tablet OLMETEC Pfizer, Inc. [Daiichi

Sankyo Europe GmbH –

Germany]

DRP-3449

(DR-XY29916)



DRP-3448

(DR-XY22915)

42

Germany]



Germany]

DRP-3450

(DR-XY29914)

Olmesartan

medoxomil +

Hydrochlorothiazide

20 mg/12.5 mg

Tablet

OLMETEC

PLUS

Pfizer, Inc. [Daiichi


Germany]

DR-XY31571

40 mg/12.5 mg

Tablet

OLMETEC

PLUS



Germany]

DR-XY32003

40 mg/25 mg

Tablet

OLMETEC

PLUS



Germany]

DR-XY32002

Omeprazole 10 mg Capsule LOSEC AstraZeneca Pharm’ls


AB – Sweden]

DR-XY18046

20 mg Capsule LOSEC AstraZeneca Pharm’ls


AB – Sweden]

DR-XY18227

40 mg Capsule Losec/Prilosec [AstraZeneca] Not available

locally

Ondansetron (as HCl) 4mg Tablet ZOFRAN [GlaxoSmithKline] Not available

locally

8mg Tablet ZOFRAN GlaxoSmithKline

Philippines, Inc. [Aspen

Bad Oldesloe GmbH]

DR-XY13371

Oxcarbazepine 300 mg Tablet TRILEPTAL Novartis Healthcare Phils.,


S.p.A. – Italy]

DR-XY22095

600 mg Tablet TRILEPTAL Novartis Healthcare Phils.,


S.p.A. – Italy]

DR-XY36562

60 mg/mL Oral

Suspension

TRILEPTAL Novartis Healthcare Phils.,

Inc. [Novartis Pharma S.A.

– France]

DR-XY27599

Oxycodone

hydrochloride

5 mg Prolonged-

Release Tablet

OXYCONTIN Mundipharma Distribution

GmbH (Philippine Branch)


United Kingdom]

DR-XY31372

10 mg Prolonged-

Release Tablet




United Kingdom]

DR-XY27751

20 mg Prolonged-

Release Tablet




United Kingdom]

DR-XY27748

43

40 mg Prolonged-

Release Tablet




United Kingdom]

DR-XY27750

80 mg Prolonged-

Release Tablet




United Kingdom]

DR-XY27749




United Kingdom]

DR-XY40279

5 mg Capsule OXYNORM Mundipharma Distribution



United Kingdom]

DR-XY32009




United Kingdom]

DR-XY32011




United Kingdom]

DR-XY32010

Oxycodone

hydrochloride +

Naloxone

hydrochloride

10 mg/5 mg

Prolonged-

Release Tablet

TARGIN Mundipharma Distribution



United Kingdom]

DR-XY40703

20 mg/10 mg

Prolonged-

Release Tablet




United Kingdom]

DR-XY40700

40 mg/20 mg

Prolonged-

Release Tablet




United Kingdom]

DR-XY40702

Pantoprazole sodium 20 mg Enteric-

Coated Tablet

ULCEPRAZ Isopharma, Inc. [Nycomed

GmbH – Germany]

DR-XY26492

PANTOLOC Takeda Healthcare Phils.,

Inc. [Takeda GmbH –

Germany]

DR-XY28439

40 mg Enteric-

Coated Tablet

ULCEPRAZ Isopharma, Inc. [Nycomed

GmbH – Germany]

DR-XY22309

PANTOLOC Takeda Healthcare Phils.,

Inc. [Takeda GmbH –

Germany]

DR-XY28438

Paracetamol 120 mg Chewable KIDDILETS United Home Products DRHR-1160

44

Tablet [United Laboratories, Inc.]

325 mg Tablet TEMPRA Taisho Pharm’ls Phils.,


DR-4396

500 mg Tablet BIOGESIC Biomedis, Inc. [United

Laboratories, Inc.]

DR-153

BIOGESIC Biomedis, Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY39670

500 mg Capsule ACETADOL Medi-Rx, Inc. DR-XY9311

100 mg/mL Oral

Suspension

(Drops)

BIOGESIC

(Orange Flavor)

Biomedis, Inc. [Amherst

Labs., Inc.]

DRHR-1167

BIOGESIC

(Orange Flavor)

Biomedis, Inc. [United

Labs., Inc.]

DR-XY39532

CALPOL GlaxoSmithKline Phils.,


DRHR-1399

CALPOL GlaxoSmithKline Phils.,


DR-XY19170

NAPREX

(Melon Flavor)


Labs., Inc.]

DRHR-1292

120 mg/5 mL Oral

Suspension

BIOGESIC

(Orange Flavor)


Labs., Inc.]

DRHR-637

BIOGESIC

(Orange Flavor)


Labs., Inc.]

DRHR-1443

BIOGESIC

(Strawberry

Flavor)


Labs., Inc.]

DRHR-638

BIOGESIC

(Strawberry

Flavor)


Labs., Inc.]

DRHR-1444

CALPOL

(Strawberry

Flavor)



DRHR-495

NAPREX

(Melon Flavor)


Labs., Inc.]

DRHR-699

250 mg/5 mL Oral

Suspension

BIOGESIC

(Orange Flavor)


Labs., Inc.]

DR-XY27612

BIOGESIC

(Orange Flavor)


Labs., Inc.]

DR-XY39533

BIOGESIC

(Strawberry

Flavor)


Labs., Inc.]

DR-XY27550

BIOGESIC

(Strawberry

Flavor)


Labs., Inc.]

DR-XY39531

CALPOL

(Orange Flavor)



DRHR-913

NAPREX Pediatrica, Inc. [Amherst DR-XY27607

45

(Melon Flavor) Labs., Inc.]

Paroxetine 20 mg Tablet SEROXAT GlaxoSmithKline Phils.,

Inc. [S.C. Europharm S.A.

– Romania]

DR-XY16055

Pentoxifylline 400mg Sustained-

Release Tablet

TRENTAL Sanofi-Aventis Philippines,


Indonesia]

DR-XY25115

Phenobarbital 15 mg Tablet


Labs., Inc.]

DR-X1824

30 mg Tablet


Labs., Inc.]

DR-5064

60 mg Tablet


Labs., Inc.]

DR-X2017

90 mg Tablet


Labs., Inc.]

DR-XY21882

Phenylephrine

hydrochloride +

Paracetamol

10 mg/500 mg

Tablet

NO-DROWSE

DECOLGEN



DR-XY29288

NO-DROWSE

DECOLGEN



Indonesia]

DR-XY42877

NEOZEP NON-

DROWSY



DR-XY30216

NEOZEP NON-

DROWSY

Myra Pharm’ls, Inc. [PT.

Medifarma Labs. –

Indonesia]

DR-XY42978

Phenylephrine

hydrochloride +

Dextromethorphan

hydrobromide +

Paracetamol

10 mg/15mg/325

mg Capsule

TUSERAN

FORTE

Medichem Pharm’ls, Inc.


DR-XY29720

TUSERAN

FORTE



Indonesia]

DR-XY41123

Phenylpropanolamine

hydrochloride +

Paracetamol

18 mg/325 mg

Capsule

ORNEX GlaxoSmithKline Phils.,


(Phils.)]

DR-9189

25 mg/325 mg

Capsule

NASATHERA Morishita-Seggs Pharm’ls,

Inc. [Morishita-Seggs

Pharm’ls, Inc.]

DR-XY4383

Phenylpropanolamine

hydrochloride +

Dextromethorphan

hydrobromide +

Paracetamol

25 mg/15 mg/325

mg Capsule

DECOLSIN Westmont Pharm’ls, Inc.


DR-6325

TUSERAN

FORTE

(For Export

Only)



DR-XY16850

12.5 mg/10 DECOLSIN Westmont Pharm’ls, Inc. DR-6475

46

mg/250 mg per 5

mL Oral

Suspension


Phenoxymethylpenici

llin Potassium

250mg Tablet PENICILLIN V

POTASSIUM

Sandoz, Inc. (MAH in the

USA) [Sandoz GmbH –

Austria]

Not available

locally

500mg Tablet PENICILLIN V

POTASSIUM

Sandoz, Inc. (MAH in the

USA) [Sandoz GmbH –

Austria]

Not available

locally

Pioglitazone

hydrochloride

15 mg Tablet ACTOS Takeda Pharm’l Phils., Inc.

[Takeda Pharm’l Co., Ltd.

– Japan]

DR-XY26848

30 mg Tablet ACTOS Takeda Pharm’l Phils., Inc.

[Takeda Pharm’l Co., Ltd.

– Japan]

DR-XY26847

Piracetam 800mg Capsule NOOTROPIL

(Tablet form)

GlaxoSmithKline


Pharma S.A. – Belgium]

DR-X5323

1.2g Capsule NOOTROPIL

(Tablet form)

GlaxoSmithKline


Pharma S.A. – Belgium]

DR-XY19323

Piroxicam 20 mg Capsule FELDENE Pfizer, Inc. [Pfizer

Pharm’ls Ltd. – China]

DRP-1991

20 mg Tablet FELDENE

FLASH

Pfizer, Inc. [Catalent UK


United Kingdom]

DRP-1990

Pitavastatin calcium 1 mg Tablet LIVALO* Kowa Co. Ltd.[Kowa Co.

Ltd. – Japan or Patheon,

Inc. – USA]

Not available

locally

2 mg Tablet LIVALO* Kowa Co. Ltd.[Kowa Co.


Inc. – USA]

Not available

locally

4 mg Tablet LIVALO* Kowa Co. Ltd.[Kowa Co.


Inc. – USA]

Not available

locally

*This is the innovator product and should be purchased from a well regulated market

with stringent regulatory authority i.e., from countries participating in the International

Conference on Harmonization (ICH).

Potassium citrate 1.080 g (10 mEq)

Tablet

ACALKA Patriot Pharm’ls Corp.

[Ferrer Internacional S.A. –

Spain]

DR-XY20542

1.080 g (10 mEq)

Extended-Release

Tablet

TASCIT Biomedis, Inc. [Amherst

Labs., Inc.]

DR-XY37174

Pramipexole

hydrochloride

250 mcg Tablet SIFROL Boehringer Ingelheim


DR-XY27922

47



1 mg Tablet SIFROL Boehringer Ingelheim




DR-XY27920

Pravastatin sodium 20 mg Tablet PRAVAZ Westmont Pharm’ls, Inc.


DR-XY33868

40 mg Tablet PRAVAZ Westmont Pharm’ls, Inc.


DR-XY33869

Praziquantel 600 mg Tablet BILTRICIDE Bayer Phils., Inc. [Bayer


DR-X6396

BILTRICIDE* [Bayer Healthcare] Not available

locally





FLUXIDE** Blue Sky Trading Co., Inc.


Labs., Inc.]

DR-XY28000

**FLUXIDE may be considered as the alternative comparator

product once equivalence with BILTRICIDE has been


Prednisone 5 mg Tablet ORASONE 5 Phoenix Pharm’l, Inc.


Labs., Inc.]

DR-XY1584

10 mg Tablet ORASONE 10 Phoenix Pharm’l, Inc.


Labs., Inc.]

DR-XY33699

20 mg Tablet ORASONE 20 Phoenix Pharm’l, Inc.


Labs., Inc.]

DR-XY22998

Pregabalin 25 mg Capsule LYRICA Pfizer, Inc. [Pfizer

Manufacturing


Germany]

DR-XY32505

50 mg Capsule LYRICA Pfizer, Inc. [Pfizer

Manufacturing


Germany]

DR-XY32506


Manufacturing


Germany]

DR-XY30678


Manufacturing

DR-XY32507

48


Germany]


Manufacturing


Germany]

DR-XY30679


Manufacturing


Germany]

DR-XY32504


Manufacturing


Germany]

DR-XY31133

Propylthiouracil 50 mg Tablet Unbranded Philusa Corp. [Surepharm

Services Ltd. – United

Kingdom]

DR-XY2509

Pyrantel embonate 125 mg Tablet COMBANTRIN Johnson & Johnson Phils.,

Inc. [PT. Pfizer Indonesia –

Indonesia]

DR-769

250 mg Tablet COMBANTRIN Johnson & Johnson Phils.,

Inc. [PT. Pfizer Indonesia –

Indonesia]

DR-X1110

125 mg/5 mL Oral

Suspension

COMBANTRIN Johnson & Johnson Phils.,


DR-X2920

Pyrantel embonate +

Oxantel embonate

100 mg/100 mg

Tablet

QUANTREL Johnson & Johnson Phils.,


DR-X7039

20 mg/20 mg per

mL (100 mg/100

mg per 5 mL)

Oral Suspension

QUANTREL Johnson & Johnson Phils.,


DR-X7040

Pyrazinamide 500 mg Tablet PZA-CIBA Sandoz Phils. Corp.


DR-XY25118



DR-XY9200

250 mg/5 mL Oral

Suspension

PZA-CIBA Sandoz Phils. Corp.


DR-XY25264

ZCURE Natrapharm, Inc. [Lloyd

Labs., Inc.]

DR-XY27677

500 mg/5 mL Oral

Suspension

ZCURE FORTE Natrapharm, Inc. [Lloyd

Labs., Inc.]

DR-XY35466

Quinine sulfate 325 mg Tablet Unbranded Philusa Corp. [Amherst

Labs., Inc.]

DR-X1607

49

Quetiapine fumarate 25 mg Tablet SEROQUEL AstraZeneca Pharm’ls



DR-XY25575

100 mg Tablet SEROQUEL AstraZeneca Pharm’ls



DR-XY25574




DR-XY25573



UK Ltd. – United

Kingdom]

DR-XY30815

Raloxifene

hydrochloride

60 mg Tablet EVISTA Takeda Pharm’ls (Phils.),

Inc. [Lilly S.A. – Spain]

DR-XY24477

Ranitidine

hydrochloride

75 mg Tablet ZANTAC GlaxoSmithKline Phils.,


(Tianjin) Co. Ltd. – China]

DR-XY22461




DR-XY1971




DR-XY3594

Ranolazine 375 mg Extended-

Release Tablet

RANEXA Menarini Int’l Operations

Luxembourg S.A. [Fine

Foods N.T.M. SpA – Italy

or Menarini-Von Heyden

GmbH – Germany or

Berlin-Chemie AG –

Germany]

Not available

locally

500 mg Extended-

Release Tablet





GmbH – Germany or


Germany]

Not available

locally

RANEXA Gilead Sciences, Inc.

(MAH in the USA)

Not available

locally

750 mg Extended-

Release Tablet



Not available

locally

50



GmbH – Germany or


Germany]

1 g Extended-

Release Tablet

RANEXA Gilead Sciences, Inc.

(MAH in the USA)

Not available

locally

Repaglinide 500mcg Tablet NOVONORM Novo Nordisk

Pharmaceuticals (Phils.)

Inc. [Boehringer Ingelheim

Pharma KG – Germany]

DR-XY25437

1mg Tablet NOVONORM Novo Nordisk




DR-XY25438

2mg Tablet NOVONORM Novo Nordisk




DR-XY25439

Retinol palmitate 25,000 IU

Capsule

AFAXIN Sanofi-Aventis Phils., Inc.

[Catalent Australia Pty.

Ltd. – Australia]

DR-2133

50,000 IU

Capsule

AFAXIN Sanofi-Aventis Phils., Inc.

[Catalent Australia Pty.

Ltd. – Australia]

DR-2134

Rifampicin 300 mg Capsule RIMACTANE Sandoz Phils. Corp.


DR-XY25116

600 mg Tablet RIMACTANE Sandoz Phils. Corp.


DR-XY25117

200 mg/5 mL Oral

Suspension

NATRICIN

FORTE

Natrapharm, Inc. [Lloyd

Labs., Inc.]

DR-XY23213

Rifampicin +

Isoniazid

150 mg/75 mg

Tablet

BIFIX United American Pharm’ls,

Inc. [Amherst Labs, Inc.]

DR-XY28918

300 mg/150 mg

Tablet

RIMACTAZID Sandoz Phils. Corp.


DR-XY25265

450 mg/400 mg

Tablet

RIMACTAZID Sandoz Phils. Corp.


DRP-5099 (DR-

XY25238)

Rifampicin +

Ethambutol +

Isoniazid

150 mg/300

mg/75 mg Tablet

MYRIN Pfizer, Inc. [Wyeth

Pakistan Ltd. – Pakistan]

DRP-3365 (DR-

XY23595)

Rifampicin + 150 mg/275 MYRIN FORTE Pfizer, Inc. [Wyeth DRP-3810 (DR-

51

Ethambutol +

Isoniazid +

Pyrazinamide

mg/75 mg/400 mg

Tablet

Pakistan Ltd. – Pakistan] XY23682)

Risperidone 1 mg Tablet RISPERDAL Johnson & Johnson


S.p.A. – Italy]

DR-XY40691

2 mg Tablet RISPERDAL Johnson & Johnson


S.p.A. – Italy]

DR-XY40690

1 mg

Orodispersible

Tablet

RISPERDAL

QUICKLET

Johnson & Johnson

(Phils.), Inc. [Janssen-

Ortho LLC – Puerto Rico]

DR-XY30041

2 mg

Orodispersible

Tablet

RISPERDAL

QUICKLET

Johnson & Johnson

(Phils.), Inc. [Janssen-

Ortho LLC – Puerto Rico]

DR-XY30048

Roflumilast 500mcg Tablet DAXAS Nycomed Philippines

[Takeda GmbH –

Germany]

DR-XY40659

Rosuvastatin calcium 5 mg Tablet CRESTOR AstraZeneca Pharm’ls

(Phils.), Inc. [IPR Pharm’l


DR-XY31354

10 mg Tablet CRESTOR AstraZeneca Pharm’ls



DR-XY28499




DR-XY28498




DR-XY28497

Roxithromycin 150mg Tablet RULID Sanofi-Aventis Philippines,


Indonesia]

DRP-1914

300mg Tablet RULID Sanofi-Aventis Philippines,


Indonesia]

DRP-2130

Salbutamol sulfate 2 mg Tablet VENTOLIN GlaxoSmithKline Phils.,

Inc. [Aspen Bad Oldesloe

GmbH – Germany]

DR-6009

Salbutamol sulfate +

Guaifenesin

2 mg/100 mg

Capsule

VENTOLIN

EXPECTORANT



DRP-4347

(DR-XY10751)

52

(Phils.)]

Sertraline

hydrochloride

50 mg Tablet ZOLOFT Pfizer, Inc. [Pfizer


Australia]

DRP-1931

Sevelamer carbonate 800mg Tablet RENVELA Sanofi-Aventis Philippines,

Inc. [Genzyme Ireland Ltd.

– Ireland]

DRP-5212

(DR-XY36510)

Sildenafil citrate 25 mg Tablet VIAGRA Pfizer, Inc. [Pfizer PGM –

France]

DRP-3434

50 mg Tablet VIAGRA Pfizer, Inc. [Pfizer


Australia]

DRP-2072

100 mg Tablet VIAGRA Pfizer, Inc. [Pfizer


Australia]

DRP-2073

Simethicone 40mg Chewable

Tablet

DISFLATYL A. Menarini Philippines,

Inc. [Olic (Thailand)

Limited – Thailand]

DR-XY40471

Simvastatin 10 mg Tablet ZOCOR Merck Sharp & Dohme



Kingdom]

DR-XY14848

20 mg Tablet ZOCOR Merck Sharp & Dohme



Kingdom]

DR-XY14849




Kingdom]

DR-XY23881




Kingdom]

DR-XY27257

Solifenacin Succinate 5mg Film-Coated

Tablet

VESICARE Astellas Pharma

Philippines, Inc. [Astellas

Pharma Europe B.V. –

Netherlands]

DR-XY31747

10mg Film-

Coated Tablet

VESICARE Astellas Pharma

Philippines, Inc. [Astellas

Pharma Europe B.V. –

Netherlands]

DR-XY31760

Spironolactone 25 mg Tablet ALDACTONE Pfizer, Inc. [Piramal


United Kingdom]

DRP-2016

53

50 mg Tablet ALDACTONE Pfizer, Inc. [Piramal


United Kingdom]

DRP-2013

100 mg Tablet ALDACTONE Pfizer, Inc. [Piramal


United Kingdom]

DRP-2014

Spironolactone +

Hydroflumethiazide

25 mg/25 mg

Tablet

ALDAZIDE Pfizer, Inc. [Piramal


United Kingdom]

DR-7294

Sulfadoxine +

Pyrimethamine

500 mg/25 mg

Tablet

FANSIDAR Roche (Phils.), Inc. [F.


Switzerland]

DR-9514

Sultamicillin tosilate 375 mg Tablet UNASYN Pfizer, Inc. [Pfizer Japan

Inc. – Japan]

DRP-3451

(DR-XY15597)

750 mg Tablet UNASYN Pfizer, Inc. [Haupt Pharma


DRP-2076

250 mg/5 mL

Powder for Oral

Suspension

UNASYN Pfizer, Inc. [Haupt Pharma


DRP-2015

(DR-XY13059)

Tacrolimus 500 mcg Capsule PROGRAF Astellas Pharma Phils., Inc.

[Astellas Ireland Co. Ltd. –

Ireland]

DR-XY34549

1 mg Capsule PROGRAF Astellas Pharma Phils., Inc.


Ireland]

DR-XY24868

5 mg Capsule PROGRAF Astellas Pharma Phils., Inc.


Ireland]

DR-XY24870

500 mcg

Prolonged-

Release Capsule

ADVAGRAF Astellas Pharma Phils., Inc.


Ireland]

DR-XY43434

1 mg Prolonged-

Release Capsule



Ireland]

DR-XY43435

5 mg Prolonged-

Release Capsule



Ireland]

DR-XY43436

Tadalafil 2.5 mg Tablet CIALIS Eli Lilly (Phils.), Inc. [Lilly

del Caribe, Inc. – Puerto

Rico]

DR-XY43862

5 mg Tablet CIALIS Eli Lilly (Phils.), Inc. [Lilly

del Caribe, Inc. – Puerto

Rico]

DR-XY43863

Tamoxifen (as

citrate)

20mg Tablet NOLVADEX-D AstraZeneca

Pharmaceutical

Philippines, Inc.

DR-XY14048

54

[AstraZeneca UK Ltd.]

40mg Tablet NOLVADEX AstraZeneca (MAH in the

US)

Not available

locally

Tamsulosin

hydrochloride

200 mcg Capsule HARNAL Astellas Pharma Phils., Inc.

[Astellas Tokai Co., Ltd. –

Japan]

DR-XY21814

200 mcg Tablet HARNAL D Astellas Pharma Phils., Inc.

[Astellas Pharma Tech Co.,

Ltd. – Japan]

DR-XY34109

400 mcg

Prolonged-release

Tablet

HARNAL OCAS Astellas Pharma Phils., Inc.

[Astellas Pharma Europe

B.V. – Netherlands]

DR-XY33041

Tamsulosin

Hydrochloride +

Dutasteride

400mcg/500mcg

Capsule

DUODART GlaxoSmithKline

Philippines, Inc. [Catalent

Germany Schorndorf

GmbH – Germany]

DR-XY39352

Tegafur + Uracil 100mg/224mg

Capsule

UFT Merck, Inc. [Taiho

Pharmaceutical Co., Ltd. –

Japan]

DR-XY15894

Telmisartan 40 mg Tablet MICARDIS Boehringer Ingelheim




DR-XY24851

PRITOR GlaxoSmithKline Phils.,


Pharma GmbH & Co. KG

– Germany]

DR-XY25308

80 mg Tablet MICARDIS Boehringer Ingelheim




DR-XY24852

PRITOR GlaxoSmithKline Phils.,



– Germany]

DR-XY25307

Telmisartan +

Hydrochlorothiazide

40 mg/12.5 mg

Tablet

MICARDIS

PLUS





DR-XY27204

PRITOR PLUS GlaxoSmithKline Phils.,



– Germany]

DR-XY27817

80 mg/12.5 mg

Tablet

MICARDIS

PLUS





DR-XY27205

55




– Germany]

DR-XY27818

80 mg/25 mg

Tablet

MICARDIS

PLUS





DR-XY36121




– Germany]

DR-XY37322

Teneligliptin

hydrobromide

hydrate

20 mg Tablet TENELIA Mitsubishi Tanabe Pharma

Corp. (MAH in Japan)

Not available

locally

Tenofovir Disoproxil

Fumarate

300mg Film-

Coated Tablet

VIREAD LF (Philippines), Inc.

[Takeda GmbH –

Germany]

DR-XY43310

Terbinafine HCl 250mg Tablet LAMISIL Novartis Healthcare

(Phils.), Inc. [Novartis

Pharma Productions GmbH

– Germany]

DR-XY15999

Thiamine

hydrochloride


Labs., Inc.]

DR-5078


Labs., Inc.]

DR-X2006

Tramadol

hydrochloride

50 mg Capsule TRAMAL Mundipharma Distribution

GmbH (Phil. Branch)

[Farmaceutici Formenti

S.p.A. – Italy]

DR-XY4359

50 mg Dispersible

Tablet

TRAMAL Mundipharma Distribution

GmbH (Phil. Branch)


S.p.A. – Italy]

DR-XY27451

50 mg Prolonged-

Release Tablet

TRAMAL

RETARD


GmbH (Phil. Branch)


S.p.A. – Italy]

DR-XY38206

100 mg

Prolonged-

Release Tablet

TRAMAL

RETARD


GmbH (Phil. Branch)


S.p.A. – Italy]

DR-XY22623

TRAMUNDIN

RETARD


GmbH (Phil. Branch)

[Mundipharma GmbH –

Germany]

DR-XY25474

150 mg TRAMUNDIN Mundipharma Distribution DR-XY25472

56

Prolonged-

Release Tablet

RETARD GmbH (Phil. Branch)


Germany]

TRAMAL

RETARD


GmbH (Phil. Branch)


S.p.A. – Italy]

DR-XY38208

200 mg

Prolonged-

Release Tablet

TRAMUNDIN

RETARD


GmbH (Phil. Branch)


Germany]

DR-XY25473

TRAMAL

RETARD


GmbH (Phil. Branch)


S.p.A. – Italy]

DR-XY38207

Tramadol

hydrochloride +

Paracetamol

37.5 mg/325 mg

Tablet

DOLCET Johnson & Johnson



DR-XY28928

DOLCET Johnson & Johnson


S.p.A. – Italy]

DR-XY35024

Trimetazidine

hydrochloride

20 mg Tablet VASTAREL 20 Servier Phils., Inc. [Les



DR-XY2643

35 mg Modified-

Release Tablet

VASTAREL MR Servier Phils., Inc. [Les



DR-XY27357

VASTAREL MR Servier Phils., Inc. [Kotra

Pharma (M) Sdn. Bhd. –

Malaysia]

DR-XY42588

Tropisetron

hydrochloride

5 mg Capsule NAVOBAN Novartis Healthcare Phils.,

Inc. [Novartis


DR-XY17560

Ursodeoxycholic

Acid

150 mg Tablet DESTOLIT Norgine Limited – United

Kingdom (MAH in the

United Kingdom)

Not available

locally

500 mg Tablet URSOFALK A. Menarini Phils., Inc.

[Losan Pharma GmbH –

Germany]

DR-XY43043

250 mg Capsule URSOFALK A. Menarini Phils., Inc.

[Dr. Falk Pharma GmbH –

Germany]

DR-X8308

300 mg Capsule ACTIGALL Actavis Laboratories UT,

Inc. – USA (MAH in the

USA)

Not available

locally

Valsartan 40 mg Tablet DIOVAN Novartis Healthcare Phils.,

Inc. [Novartis

DR-XY33957

57


80 mg Tablet DIOVAN Novartis Healthcare Phils.,

Inc. [Novartis


DRP-5124


Inc. [Novartis


DRP-5123


Inc. [Novartis


DRP-5122

Verapamil

hydrochloride

40 mg Tablet ISOPTIN Abbott Labs. Phils., Inc.


– Germany]

DR-XY23051

80 mg Tablet ISOPTIN Abbott Labs. Phils., Inc.


– Germany]

DR-XY23052

180 mg Sustained-

release Tablet

ISOPTIN SR Abbott Labs. Phils., Inc.


– Germany]

DR-XY20086

(in bottle)



– Germany]

DR-XY42927

(in blister pack)

240 mg Sustained-

release Tablet



– Germany]

DR-XY5075

(in bottle)



– Germany]

DR-XY40832

(in blister pack)

Warfarin sodium 1 mg Tablet COUMADIN A. Menarini Phils., Inc.

[Taro Pharm’l Industries

Ltd. – Israel]

DR-XY14880

2.5 mg Tablet COUMADIN A. Menarini Phils., Inc.


Ltd. – Israel]

DR-3744

5 mg Tablet COUMADIN A. Menarini Phils., Inc.


Ltd. – Israel]

DR-3745

International Conference on Harmonization (ICH)

Countries officially participating in the International Conference on Harmonization (ICH) are the ICH

members European Union, Japan and USA; and the ICH observers Canada and European Free Trade

58

Association (EFTA) as represented by Switzerland. Other countries associated with ICH (through legally

binding mutual recognition agreements) include Australia, Norway, Iceland and Liechtenstein.

FDA Philippines Provisional List of Comparator Products

Documents

Transcript of FDA Philippines Provisional List of Comparator Products