CENTER FOR DRUG EVALUATION AND RESEARCH

~rovai Packa2e for:

APPLICATION NUMBER:

18-553/8006

Trade Name: Inderal L.A.

Generic Name: Propranol Hydrochloride

Sponsor: Ayerst Laboratories

Approval Date: March 21,1985

Indications: The treatment of hypertension.

CENTER FOR DRUG EVALUATION ANDRESEARCH

APPLICATION NUMBER:

18-553/8006

CONTENTS

Reviews / Information Included in this NDA Review.

A roval Letter XA rovable LetterLabelingSummary ReviewOfficer/Em 10 ee ListOffice Director MemoCross Disci line Team Leader ReviewMedical Review sChemistry Review sEnvironmental Assessment

Pharmacolo Review sStatistical Review s)Microbiolo Review(s)

Clinical Pharmacolo /Bio harmaceutics Review sRisk Assessment and Risk Mitigation Review(s)

Pro rietary Name Review(s)

Administrative/Corres ondence Document s X

CENTER FOR DRUG EVALUATION ANDRESEARCH

APPLICATION NUMBER:

18-553/8006

APPROVAL LETTER

ØA 1~-5Ga/S-l1t6

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I~r_t ...LA. (p~~a,.lcOl ñ.4~lll()M~ long açtf ngcaiisul~$)_

.~al$a ~Jtllíì"~,.ftl)itit$:l'$'tll' addlti'onal coinictltión .f!.-d' FßnrU8¥'20. l!l$5.,. .

''f $Gppl~~l i\,pH~atlo:tl ,~f.$ f'$r'rê1fh~~dJ)bys1til.n$_'e If.beHl'g.

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g;il'~~ly YOUr$ l

MAR 2 I 1985

f( t 31~/~s-Ra~nd J~ Upict,Y. M.O.

. . Actifl Ðlrectør. .Division Øftá:rdiQ.l~nainru, PrødictsOff1.ce ø'f org-_$"lt~lt lnd ReY'eWCèM¡er for Orutts and lUolt)gfas.

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,~FN..Ji~I:e.H~nnyi~PllIll5J3118185 /~~~~lliml~ll~s rø ~ i~\i,

APPROVAL

i/

CENTER FOR DRUG EVALUATION ANDRESEARCH

APPLICATION NUMBER:

18-553/8006

ADMINISTRATIVE and CORRESPONDENCEDOCUMENTS

'~:-:¡-:..g~

'~, .~

1~

\._,'

NOTICE OF APPROVALNEW DRUG APPLICATION OR SUPPLEMENT

NDA NUMBER18-'533

i.

DATE APPROVAL¡l.,~;rTER ISSUED¡V¡Prt ? I V¡M-

" :. J 10U:)

TO: FROM:

Press Relations Staff (HFI-40) ~.Bureau of Drugs

D Bureau of Veterinary MedicineATTENTION

Forward original of this fonn for publication only after approval letter has been issued arid the date of

approval has been entered above.

TYPE OF APPLICATION CATEGORY,- SUPPLEMENT, ABBREVIATED 0 SUPPLEMENT_0 ,O~I~INAL NO~ ,WTO NDA ..,0 ORloGlNAL NOA TO ANDA , ~ HUMAN

TRADE NAME (or other designated name) AND ESTABLISHÉD OR NONPROPRIETARY NAME ~il any) OF DRUG

Inderal LA (propranolol HCl long acting) , - ._-DOSAGE FORM

CapsulesHOW DISPENSEÓ~x

ACTIVE INGREDIENT(SI (as declared on label. List by established or nonproprietary nare(s) and include arount(B), i1 amount isdeclared on label.)

DOTe

propranolol HCl 80, 120, 160 mg

cNAME OF ApPLICANT (Include 'City and State)

Ayerst LaboratoriesNew York, NY 10017

PRINCIPAL INDICATION OR PHARMACOLOGICAL CATe:GORY

, Betè blocker' ,COMPLETE FOR VETERINARY ONLY'

ANIMAL SPECIES FOR WHICH APPROVED

COMPLETE FOR SUPPLEMENT ONLYCHANGE APPROVED TO PROVIDE FOR

NAMEConstance Burner Henry

NAME

Natal ia A. MorgensternFORM Fe 1642 q/7~) PREVIOUS EDITION MAY BE USED UNTIL SUPPLY IS EXHAUSTED.

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