CUMULATIVE SUPPLEMEMT ~ 2 JAH~90·DEC~90 APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 10TH EDITION u.s. DEPARTMENT OF HEALTH AND HUMAN S:=RVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION SUBSCRIBE NOW! A vailable in March 1991 New 11th Edition APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS 11th EDITION 1991 CONTENTS • Prescription Drug Product List • OTC Drug Product List • Drug Products with Approval under Section 505 of the Act Administered by the Division of Blood and Blood Products List • Discontinued Drug Product List • Orphan Drug Product Designations • Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to Achieve Adequate Dissolution • Biopharmacetitic Guidance Availability • ANDA Suitability Petitions • Patent and Exclusivity Information See Subscription Form Inside Back Cover RX DRUG ,PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / JAN'90 - DEC'90 4 AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX ASPIRIN; MEPROBAMATE CAPSULE, EXTENDED RElEASEjORAL TABLETi ORAL BIPHETAMINE,12 •.5·, , 16~1 1~'~11~l~f1idl lit~;Jt~~~1 IJit~~~M-fI " ~~~~:i~~~~~~~~~Y /~;i.d.d~~/.d# / /rs.~~1:~1~i~:~~ BJ;PHETAMINE 20 Ci) VITARINE 325MGi200MG N89127 001 FISONS EQ 10MG'BASE; MAR 02, 1987 EQ 10MGBASE NI0093 003 IJit~f..tjl I ~dl;id ~¢/dk~'nl ,", 1~~n~:~¢/~.(;~i /~;i~~!J~/.d~d~/ ASPIRIN; O~CODONE HYOROCHLORIDE; OXYCODONE TEREPHTHALATE BIPHETAMINE 7 . .5 FISONS •E~ 3. ~5MG"iBA~E; , TABLET; ORAL "I;Q '3,,,,7SMG'BASE " NI0093 (109 Ol<YCODONE AND ASPZRZH /Jit~~Af-jj It(VJ.:j~rs.¢lJ:1X#Jl AA BARR LABS 325MG;4.5MG;~ N87794 001 It~r;'::j~rs.¢/J:1A<)U /~;i.d~!J~/.d.d!J/ HAY 26, 1982 16~i6ddd~t'~~ttBiHI IAAI -7~~~~7~~~~1 - lit~cl~;~~~~;~§~~1 ANIAZOLINE PHOSPHATE; NAPHAZOLINE ""()ROCtlLORIDE Irs.~~n~~%~:~~ SOLUTION/DROPS;' OPHTHiLMIC ATENOLOL VA~~~:"':HARMS O.5%;0.Q5;?1i N18,746 001 APR 30, 199,0 TABLET; ORAL TENORMIN ICI PHARM 25MGn N18240004 ASPIRIN; BUTALBITAL; CAFFEINE;' CODE'INEPHOSPHATE APR 09, 1990 CAPSULEi ORAL FIORlNAL H/CODEINE NO 3 ATENOLOL; CHlORTHALIDONE SANDOZ 325MGi50MGi40MGi3()MGil N19429 003 OCT 26, 1990 TABLET; ORAL ATEtlOLOL AND CHLORTHAL%DONE AB ' ICI PHARMS 50MG i 25MGII N72301 001 ASPIRIN; CAFFEINE; ORP,HENADRINE CITRATE HAY 31, 1990 ~ lQQt:l2i~ N72302 001 TABLET; ORAL ,'," , ',' '.' ' MAY 31, 1990 TEHOR!T%C 100 h~~/~'~j~~~~~t!¢~!~~~I~~~~¢Jj~~,U~~rs.¢/ /~j~~~,t~~~11 ~ STUART PHARMS 100MGi25MG N18760 001 / J~/I'-~.• /,... pp JUN 08, 1984 a VITARINE 38.5,tiGi 30M~;i 25MG' N71564 001 TEHOR!T%C 50 JUNZ3,1988 AB STUART PHARMS a.ru:12;25MG N18760 002 JUN 08, 1984 /~~/~~~~~~~,i/~~~I~~~~~~~~a~~~~;, IJ~~~~~1%~~a~ aVITARINE 770MG;60~)50MG N71565 001 ATROPINE SULFATE JUN 23, 1988 AEROSOL, METEREDiINHALATION , ATROPINE SULFATE DEPT ARMY EQ 0.36MG,BASE/IN~" N20056 001 SEP 19, 1990 -,,' " '/ RX DRUG PRODUCT LIST 1 CUMULATIVE $UPPtEMfHT NUMBER 121 JAN'90 - DEC'90 5 ATROPINE SULFATE> DIPHENOXVLATE HYDROCHLORIDE BACLOFEN TABLET; ORAL TABLET; ORAL . D%PHEHQKXLATEHCL AHD ATRO~E SULFATE > DL T > . 1':tdIfIf"'.,:n!l1 AA MYLAN PHARM$ 0.025I1G;2.5MG N85762 001 > DLT >/6DI ~~tj~J7~~A~I'l~1 I~I liil I~A~~t/~X#.~1 /a;~gtri~1 1~1>.1t'JtI.6.6U > DLT > a PARKE DAVIS. 0,;025I'1G.;2-/5MG. N87131 001 1.J~~7~~~~~~~~ '. .1r1tP.tJ~tld11f~t1}6' 'tJat!Mp.:t~~ili1tl I Iii . If'1j~~lp~A~/'l. 7Llg~cl§.{t,]rJGI 1~1>~.1('1./.6#1 >~> BEPRIDIL HYDROCHLORIDE > ADD > TABLET; ORAL ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE > ADD > BEPAD:EH > ADD> A§ HALLACE 200MGaI N19001 001 INJECTABLE; INJECTION > ADD > DEC 28, 1990 ATRoPl:HE .AHDDEHEROL > ADD> AB ~ N1900.1 002 16P.! ./#t~f;t~td#~¢1 la;~ld'(.tdtf;ltb;t Jr;.1I>~;J,/~#J > ADD > - DEC 28, 1990 > ADD> A§ 400MGaI N19001 003 laP.! I~Ghl'ft.tri~'1 '~~~~~AA~~~~~ > ADD> DEC 28, 1990 1~~11f.~ .• ff~n >..A!llL> VASCOR laP.! 1~ltb;.fillr:JrUtb;1 > ADD> A§ RH JOHNSON 200MGaI N19002 001 I~~~~~~~~:~~ > ADD> DEC 28, 1990 STERLING DRUG 0.4MG/ML;50MG/ML :N87853 .001 >-AJllL> AB llruLGai N19002 002 NO't26" 1982 > ADD > DEC 28, 1990 Oi4MG/ML;75MG/ML N87847 001 > ADD). A§ 400MGa N19002 003 NOV 2~, 1982 > ADD > DEC 28, 1990 0~4Mt;/ML;100MG/ML N87848 001 NOV 26, 1982 MEPER%D:EHE AHD ATROP:EHE, SULFATE BETAMETHASONE DIPROPIONATE /~:ftJtllm~#/UW '~4~!lt ~~~~~~~~.~~~ CREAM; TOPICAL ,~~ mf.#,.#/~~"J1 BETAME111ASOHE DXPROPJ:OHATE Gl WYETH AYERST LABS 0;·4MG/ML;50M(;/ML . N85121 001 A§ CLAY PARK LABS EQ 0,05% BASEa N72536 001 Gl O.4MG/ML;75MG/ML ~85121 Q02 JAN 31, 1990 Gl 0"4I'1G/ML; 100MG/ML N85121 003 LOTIOm TOPICAL BETAMrn1ASOHE DXPROPXOHATE BACLOFEN AB CLAY PARK LABS EQ 0.05Y. BASEa N72538 001 JAN 31, 1990 TABLET; ORAL BACLOFEN OINTMENT; TOPICAL I~~I 1~;tfA~;t~tl n.61'l¢1 mjj.Mf./~6U BETAMETHASOHE DXPROPJ:OHATE AS CLAY PARK LABS EQ 0.05Y. BASEa N72526 001 I~~/ 11..61'l¢( I A~~~.,j.. j. .•... ~:~.~'•... 9i,~~I!~ JAN 31, 1990 '~ .:. :: ~.\. :, "." ..... IA~~VJ~::ij.~~~1 .)~rrAItINE 10MG N71901001 : ." . , . ~. APR 13, 1988 BROMPHENIRAMINE MALEATE Gl 20MG::;' N71902 001 AP,R~3, 1988 INJECTABLE.; INJECTION > ADD > UORE5AL BROMPHENIRAMINE MALEATE· 20MG .. > ADD > AB "GEIGY;PHARMS ,N17851 003 l~ft~j~/tA~~1 1j.~~I'l¢;l'lt/ I~I! ~1!~.61.6.6 j./ > ADD > JAN 20, 1982 a STERIS LABS 100MG/ML N83820 001 PRODUCT LIST I CUMULATIVE SUPPLEMENT NUMBER 12 I JAN'90 - DEC'90 12 CLORAZEPATE,DIPDTASSIlJM CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE , ' , TABLEHORAL , l;t~)t¢#~~t,;'/;t~)t¢f;t~/ CLORAZEPA'rE' D:EPOTASs;tU1 ~ CORD LABS' 3 .• 7SMGA N72512 001 IP7~~~~I1~/~~~~'V 1.6 :ptf¢MtJ~.:f.tf¢/tlt {f MAY 11, 1990 Ij.~¢/tftl ' /~j.j.~#/~,6j./ ~7.SMGA N72S13 001 a ARMOUR PHARM 0.SMG/ML;2.3MGIML; MAY 11, 1990 IMG/ML N11208 001 AS lSMGA N72514 001 MAY 11, 1990 CYCLOSPORINE' CLOTRIMAZOLE' CAPSULE; ORAL SANDIMMUNE CREAM; VAGINAL SANDOZ PHARMS 25MGA NS062S 001 MAR 02, 1990 16tl IS~~~~~l~a;~1 1f.31 1~j.~~~~1.6,6j./ 100MGA NS0625 002 ~CELE)(.G . MAR 02, 1990 I Ail' ~t1ttt~N~~~I'V Ittl I~j.~~f.~/#j./ MIL.ESPHARM 1% N18230 001 CYPROHEPTADINE HYDROCHLORIDE TABLET; VAGINAL TABLET; ORAL I 'tI"/rJ~~~~f~!~~tV 11J.~~rJl I~j.jjj.j1.6,6j./ CY~ROHEPTAD:EHE HCL MYCELE)(.G 1"1 I ~/~~A~t1I I~HrJl 1~~~jf..1I.d,dj./ /6tl /t1ttt~7~~~~~1 /1.~~HrJ/ /~j.M~M,6,6j./ a KV PHARM 4MG N86737 001 MILES PHARM 100MG N18182 001 > DLT >/"/ /~Il~t~~~~~~/ I~~I /~~Ht~~/~#/ > ADD > a SUPERPHARM 4MG N87405 001 CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE CYTARABINE SYRUP; ORAL INJECTABLE; INJECTION CYTARABINE 1"1 Il"~j1~~~gf 11.1tcl~l~~Jj~': (f BULL LABS 20MGIML~ N71868 001 JUN 04, 1990 Il&jHj21JffJ----~ 1~~~~~J'i~~~~ 20MGIML~ N72168 001 TR%PROL%D:EHE HCL. PSEUDOEPHEDR:tHE HCL AHD CODEEHE' AUG 31, 1990 PHoSPHATE ' AA PBI 10MG/SML;30MG/SML; 1.2SMG/SML N88833 001 > ADD > DAPIPRAZOLE HYDROCHLORIDE NOV 16, 198,4 >..A!llL> SOLUTION/DROPS; OPHTHALMIC >..A!llL> REV-EYES >.Jt!.L.> Icq(t6S~E,R~(~p.A,(~ttA#./ '. > ADD > ANGELINI PHARMS 0.5~ N19849 001 >..A!llL> DEC 31, 1990 ~ .~t~ ~ /~~~~a~~~%~a~~~~~yl1#~~h";t~~~~~¢~t~tI >..J!!..L > . "#Il~~~Il¢~#~Ut~1 ;fj.lJ~~r)N;t~p.l/ > DLT > . I ~~~':~~17i~:~~~ RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 12 / JAN'90 - DEC'90 13 DESIPRAMINE HYDROCHLORIDE DEXAMETHASONE TABLET; ORAL TABLET; ORAL DESIPRAMINEHCL DEXAMETHASONE I~U N~t~~t~t/ fj.~~¢1 If'~j~~~%~~~~ Ci) BARR LABS 0.5MG N84766 001 I~~I Itf;M¢1 1~}~~.~XI~:6f DEXAMETHASONE SODIUM PHOSPHATE '/~U /f;.6~¢1 IJ~~1~~~~76~l IJ~~~~f;,~~;t~~.111 INJECTABLE; INJECTION I~~I lJf;~¢1 I". ,L~. ,f-I .. ;t DEXAMETHASOHE SOD::tU1 PHOSPHATE IAll /j..~ttl~tpftVM~1 7t~..:.g~l'kt!d.~MthK/ 1./~~/~~~tlt~.6{11 I~# fj..6~6~¢1 1~7~~1~~~7a~~~ rtp ;t. o' ,L.~. It)(.t Nf; .• ~;(jf,j I ., INTL MEDTN SYS EQ 20MG PHOSPHATE/ML N88522 001 I~~I fj.f;.6~¢1 FEB 17, 1984 AI!. KENDALL MCGAH EQ 4MG PHOSPHATE/Mo. N81125 001 Ci)'VITARINE 10MG If'~~~~f:A~~B~N72167 00.1 AUG 31, 1990 FES03j'1988 AP EQ 10MG PHOSPHATE/M~ N81126 001 a 25MG N7160.1 .001 AUG 31, 1990 JUN05, 198.7 Ci) 50MG N71S88:001 OINTMENT; OPHTHALMIC JUN 05, 1987 HAKXDEK . ., , 75MG N71602 001 AT ALCON LABS EQ 0.05% PHOSPHATE N83342 001 OCT 05, 1987 ai, 100MG N71766 001 OCT 05, 1987 't)j~Z1~~lV,t).t1~~,(~;t¢·:'t)t;t¢' a 150MG N.72254 001 lat! I 7A~¢~~~t'(~~1 It~~~~~!dAttl I~~~~,t/~~;tl FE~03, 19.88 '~t)~~~~~1~~~f~~:ru,(~~~iptlt' DESMOPRESSIN ACETATE IAtl I 7~j~~;t~nA~~r--t-~-!/i -. !J ~.1d~~Ed6ttl IJ~~'1~~%~:~~ SOLUfioNP·NASAL ' > ADD > CQNCENTRAID SOLUTION/DROPS; OPHTHALMIC, OTIC > ADD >FERRING LABS 0'.01X. DEXAMEnlASOHE SOD:tU1 PHOSPHATE >-AR!L> DE~lir~~l~~~ AT STERIS LABS Elr 0.1% PHOSPHATE N88771 001 JAN 16. 1985 PESOXIMETAsONE PEXTROAMPHETAMINE SULFATE CREAtH' TopICAL' .. DESO>aMETASOHE >...P.!.I...> AS . "'TARO PHARMS 0.05%)1 N73210 001 > DLT > 1¢1~~~~;'~1~tI NOV .3.0, 1990 > DLT > Ittt1t1t)~1 '. 1tf;~¢1 1~~f;~f;f;1.6~j.f M 0.25%)1 N73193 :001 >-AR!L> Ci) LEMMON 15MG N85355 001 NOV/3D:, '. 19'9(r TOP%CORI AS .HOECHST 0.257. N17856 001 TOP%CORT:!LP :~,,~~,. AB ,0 HOECHST ():05% N18309 001 ";'." "."; '."~ " · >.,.,." >. ' .. ,' •.' .,', ~-_'. -.,_-, -"_~, '.'__ , ....... ' •• "'.- ,,~ •• -....;::..~. ~.-..J\ .... ,-..... ::'"..l"..... ~~~....... 'J.l!"_-';'"l'.'!I:':"::'I..O:.J..~1"~"'.1'_:;.Y."'_'Jt"':~'"i.~Z~~~'o:..<~,;It'~:-17.