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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.
W~"b~~ ~pll~tl'~~~:i~(lf tilt$ sUPl'l~ntal fiflPl ttUttlon and lth(lPjf:ved. .lhrJl~~l~f~PMl 19. ll83 détaned tte ccndi t:l.otlsrelatfft9 t9.tll _PPi'll (l~~$ai.ll~atf-i. .
g;il'~~ly YOUr$ 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-_$"lt~lt lnd ReY'eWCèM¡er for Orutts and lUolt)gfas.
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APPROVAL
i/
CENTER FOR DRUG EVALUATION ANDRESEARCH
APPLICATION NUMBER:
18-553/8006
ADMINISTRATIVE and CORRESPONDENCEDOCUMENTS
'~:-:¡-:..g~
'~, .~
1~
\._,'
NOTICE OF APPROVALNEW DRUG APPLICATION OR SUPPLEMENT
NDA NUMBER18-'533
i.
DATE APPROVAL¡l.,~;rTER ISSUED¡V¡Prt ? I V¡M-
" :. J 10U:)
TO: FROM:
Press Relations Staff (HFI-40) ~.Bureau of Drugs
D Bureau of Veterinary MedicineATTENTION
Forward original of this fonn for publication only after approval letter has been issued arid the date of
approval has been entered above.
TYPE OF APPLICATION CATEGORY,- SUPPLEMENT, ABBREVIATED 0 SUPPLEMENT_0 ,O~I~INAL NO~ ,WTO NDA ..,0 ORloGlNAL NOA TO ANDA , ~ HUMAN
TRADE NAME (or other designated name) AND ESTABLISHÉD OR NONPROPRIETARY NAME ~il any) OF DRUG
Inderal LA (propranolol HCl long acting) , - ._-DOSAGE FORM
CapsulesHOW DISPENSEÓ~x
ACTIVE INGREDIENT(SI (as declared on label. List by established or nonproprietary nare(s) and include arount(B), i1 amount isdeclared on label.)
DOTe
propranolol HCl 80, 120, 160 mg
cNAME OF ApPLICANT (Include 'City and State)
Ayerst LaboratoriesNew York, NY 10017
PRINCIPAL INDICATION OR PHARMACOLOGICAL CATe:GORY
, Betè blocker' ,COMPLETE FOR VETERINARY ONLY'
ANIMAL SPECIES FOR WHICH APPROVED
COMPLETE FOR SUPPLEMENT ONLYCHANGE APPROVED TO PROVIDE FOR
NAMEConstance Burner Henry
NAME
Natal ia A. MorgensternFORM Fe 1642 q/7~) PREVIOUS EDITION MAY BE USED UNTIL SUPPLY IS EXHAUSTED.
VETERINAR'
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lISUALDOSAGE: Read Accömpan~iliS ÓescriptiveLiterature; ,
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- NOTE: Paekagé nøtchlld-!'slstarit. ,
STQF,EAT ROÖM TEMPERATURE (APPR9XIMATELY25°qpROTECTFRONlllGHTAND MOISTURE '. " .' '...,The iipåarlrì Of lhes capsules is á reiSler$ I.rlidémllk ÔfAyers I.rål9riEls.
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FORFULL PRODUCTINFORMATION;SE!:ACCOMPANYINGPACKAGE CIRCULAR. '
NO!E: Package notcbUd.tØslslant. ",.. .'"...'.' ".., .''SToRE.AT,ROOM'TEMPERATURE:(APPROXIMATELY~5.C)PROTECT FROMUGHTAND,MOISiyRE..... '.' " .'
TIe appearance of thesC8SUles is a reislér9lr¡idemàrk òi ..yers Laralories.
Jøn11v manulare by lii~rialChlim~ Indus!éspi,O;Miièsfiiild,ChehiieSK10 4TF, UnrtejKin!ioianAyersla?ries Inc;¡ NiiYork, NY 1097
IA..' '~...".. """ (.~.l. ~.:~.e~i%...." 'RAlO. .,' RIÈS INC. U.S. Pat No. 4,138,475 ~,..." ;NeYork, NY 1007Prnled;nU,S.A.
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USUAL DOSAGE: ReadACcompanyirig De$criptiveLiterattrrë.
FOR FULL PRODUCT INFORMATION, SEE ACCOMPANYING PACKAGE CIRCULAR.
NOTE: Package not chiid-reliistant. . .'
STOREAT ROOM TEMPERATURE(APPROXIt\ATELY 25ÒC)PFlOTECT FROM LIGHT AND MOISTURE, ' ,The aPpèaranceot these capsules is a ~jstere trademark Qf Ayerst uibQråtofies.
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STORE AT,ROOM TEMPERATURE (APPROXIMATELY 25°C)PROTECT FROM LIGHT AND MOISTURE. "The appearal1e of theSe casules is a reisteie lrádeniark of Âyerstl!ralories.
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USUAL DOSAGE: Read Accompanying Descriptive Litèrature. _
FOR FULL PRODUCT INFORMATION, SEE ACCOMPANYING PACKAGEÇIRCULAR.
NOTE: Packågenot child"reslstant., , SmRËAT ROOM TEMPERATURE (APPROXIMATELY 25°C)
PROTECT FROM LIGHT AND MOISTURE, " The appearance of these casùles is a reistere tradíÙnal' of Ayerst lioratoiies,
Joinfly manufar9 by Imperial Chemicals Industres PLC,Macesfield, Cheshire SKlO 4TF, .lnned Kingdomand Aye Laratories Inc., NE! Yor, NY 10017
I A.' I Mal'etéd by ""ye, (I' AYER$I LABORA. mRIES INC. U.S. Pat., No. 4,138,475.', " . NewYol', NY 1007
Prnted in U.S.A. _/