U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
U.S. Food and Drug Administration • Center for Drug Evaluation
and Research |
 |
Center for Drug Evaluation and Research |
 |
NOTE: The format for the Monthly Additions/Deletions Drug Product List has changed as of the July Cumulative Supplement (CS) of the 21st Edition to mirror the CS. Refer to the CS Preface section 1.5 CUMULATIVE SUPPLEMENT LEGEND.
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
TABLET; ORAL
FIORICET
>D> AB + NOVARTIS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN
>A> AB + WATSON PHARMS 325MG;50MG;40MG N88616 001 NOV 09, 1984 APR CAHN
ACYCLOVIR
CAPSULE; ORAL
ACYCLOVIR
>A> AB AAIPHARMA 200MG N74833 001 APR 22, 1997 APR CAHN
>D> AB AESGEN 200MG N74833 001 APR 22, 1997 APR CAHN
ALBUTEROL SULFATE
SOLUTION; INHALATION
ALBUTEROL SULFATE
>A> AN NOVEX EQ 0.5% BASE N76391 001 APR 01, 2003 APR NEWA
ALMOTRIPTAN MALATE
TABLET; ORAL
AXERT
>A> JANSSEN ORTHO EQ 6.25MG BASE N21001 001 MAY 07, 2001 APR CAHN
>A> + EQ 12.5MG BASE N21001 002 MAY 07, 2001 APR CAHN
>D> PHARMACIA AND UPJOHN EQ 6.25MG BASE N21001 001 MAY 07, 2001 APR CAHN
>D> + EQ 12.5MG BASE N21001 002 MAY 07, 2001 APR CAHN
AMANTADINE HYDROCHLORIDE
CAPSULE; ORAL
AMANTADINE HCL
>A> AB GENEVA PHARMS 100MG N71293 001 FEB 18, 1987 APR CAHN
>D> AB GENEVA PHARMS TECH 100MG N71293 001 FEB 18, 1987 APR CAHN
AMCINONIDE
CREAM; TOPICAL
>A> AMCINONIDE
>A> AT TARO PHARM INDS 0.1% N76229 001 MAY 31, 2002 APR NEWA
CYCLOCORT
>D> + FUJISAWA HLTHCARE 0.1% N18116 002 APR CFTG
>A> AT + 0.1% N18116 002 APR CFTG
AMIODARONE HYDROCHLORIDE
INJECTABLE; INJECTION
AMIODARONE HCL
>A> AP APOTEX 50MG/ML N76394 001 APR 25, 2003 APR NEWA
AMMONIUM LACTATE
CREAM; TOPICAL
AMMONIUM LACTATE
>A> AB TARO EQ 12% BASE N75883 001 APR 10, 2003 APR NEWA
AZELASTINE HYDROCHLORIDE
SOLUTION/DROPS; OPHTHALMIC
OPTIVAR
>A> + MEDPOINTE 0.05% N21127 001 MAY 22, 2000 APR CAHN
>D> + MURO 0.05% N21127 001 MAY 22, 2000 APR CAHN
CARBINOXAMINE MALEATE
>A> SOLUTION; ORAL
>A> CARBINOXAMINE MALEATE
>A> + MIKART 4MG/5ML N40458 001 APR 25, 2003 APR NEWA
CARVEDILOL
TABLET; ORAL
COREG
>D> GLAXOSMITHKLINE 12.5MG N20297 002 SEP 14, 1995 APR CRLD
>A> + 12.5MG N20297 002 SEP 14, 1995 APR CRLD
>D> + 25MG N20297 001 SEP 14, 1995 APR CRLD
>A> 25MG N20297 001 SEP 14, 1995 APR CRLD
>D> CEFIXIME
>D> FOR SUSPENSION; ORAL
>D> SUPRAX
>D> + LEDERLE 100MG/5ML N50622 001 APR 28, 1989 APR DISC
>A> @ 100MG/5ML N50622 001 APR 28, 1989 APR DISC
>D> TABLET; ORAL
>D> + LEDERLE 200MG N50621 001 APR 28, 1989 APR DISC
>A> @ 200MG N50621 001 APR 28, 1989 APR DISC
>D> + 400MG N50621 002 APR 28, 1989 APR DISC
>A> @ 400MG N50621 002 APR 28, 1989 APR DISC
CEFUROXIME AXETIL
TABLET; ORAL
CEFUROXIME AXETIL
>A> AB RANBAXY EQ 125MG BASE N65118 001 APR 25, 2003 APR NEWA
>A> AB EQ 250MG BASE N65118 002 APR 25, 2003 APR NEWA
>A> AB EQ 500MG BASE N65118 003 APR 25, 2003 APR NEWA
CLADRIBINE
INJECTABLE; INJECTION
LEUSTATIN
>D> + ORTHO BIOTECH 1MG/ML N20229 001 FEB 26, 1993 APR CTEC
>A> AP + 1MG/ML N20229 001 FEB 26, 1993 APR CTEC
CLONAZEPAM
TABLET, ORALLY DISINTEGRATING; ORAL
KLONOPIN RAPIDLY DISINTEGRATING
>D> @ ROCHE 0.125MG N20813 001 DEC 23, 1997 APR CMFD
>A> 0.125MG N20813 001 DEC 23, 1997 APR CMFD
>D> @ 0.25MG N20813 002 DEC 23, 1997 APR CMFD
>A> 0.25MG N20813 002 DEC 23, 1997 APR CMFD
>D> @ 0.5MG N20813 003 DEC 23, 1997 APR CMFD
>A> 0.5MG N20813 003 DEC 23, 1997 APR CMFD
>D> @ 1MG N20813 004 DEC 23, 1997 APR CMFD
>A> + 1MG N20813 004 DEC 23, 1997 APR CMFD
>D> @ 2MG N20813 005 DEC 23, 1997 APR CMFD
>A> 2MG N20813 005 DEC 23, 1997 APR CMFD
CORTISONE ACETATE
TABLET; ORAL
CORTISONE ACETATE
>D> BP PHARMACIA AND UPJOHN 25MG N08126 001 APR CRLD
>A> BP + 25MG N08126 001 APR CRLD
>D> CORTONE
>D> BP + MERCK 25MG N07750 003 APR DISC
>A> @ 25MG N07750 003 APR DISC
CYCLOBENZAPRINE HYDROCHLORIDE
TABLET; ORAL
FLEXERIL
>D> AA MCNEIL CONS SPECLT 5MG N17821 001 APR CTEC
>A> 5MG N17821 001 APR CTEC
>A> DESIRUDIN
>A> INJECTABLE; SUBCUTANEOUS
>A> IPRIVASK
>A> + AVENTIS PHARMS 15MG/VIAL N21271 001 APR 04, 2003 APR NEWA
DEXAMETHASONE
ELIXIR; ORAL
>D> DECADRON
>D> AA + MERCK 0.5MG/5ML N12376 002 APR DISC
>A> @ 0.5MG/5ML N12376 002 APR DISC
HEXADROL
>D> AA ORGANON 0.5MG/5ML N12674 001 APR CRLD
>A> AA + 0.5MG/5ML N12674 001 APR CRLD
DEXAMETHASONE SODIUM PHOSPHATE
INJECTABLE; INJECTION
DEXAMETHASONE SODIUM PHOSPHATE
>A> AP AM PHARM EQ 10MG PHOSPHATE/ML N40491 001 APR 11, 2003 APR NEWA
DIHYDROERGOTAMINE MESYLATE
INJECTABLE; INJECTION
D.H.E. 45
>D> XCEL PHARMS 1MG/ML N05929 001 APR CFTG
>A> AP + 1MG/ML N05929 001 APR CFTG
>A> DIHYDROEROGTAMINE MESYLATE
>A> AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA
DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE; ORAL
>A> TAZTIA XT
>A> AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA
>A> AB4 180MG N75401 002 APR 10, 2003 APR NEWA
>A> AB4 240MG N75401 003 APR 10, 2003 APR NEWA
>A> AB4 300MG N75401 004 APR 10, 2003 APR NEWA
>A> AB4 360MG N75401 005 APR 10, 2003 APR NEWA
TIAZAC
>D> BC + BIOVAIL 120MG N20401 001 SEP 11, 1995 APR CFTG
>A> AB4 + 120MG N20401 001 SEP 11, 1995 APR CFTG
>D> BC + 180MG N20401 002 SEP 11, 1995 APR CFTG
>A> AB4 + 180MG N20401 002 SEP 11, 1995 APR CFTG
>D> BC + 240MG N20401 003 SEP 11, 1995 APR CFTG
>A> AB4 + 240MG N20401 003 SEP 11, 1995 APR CFTG
>D> BC + 300MG N20401 004 SEP 11, 1995 APR CFTG
>A> AB4 + 300MG N20401 004 SEP 11, 1995 APR CFTG
>D> + 360MG N20401 005 SEP 11, 1995 APR CFTG
>A> AB4 + 360MG N20401 005 SEP 11, 1995 APR CFTG
ERYTHROMYCIN
SOLUTION; TOPICAL
STATICIN
>D> AT + WESTWOOD SQUIBB 1.5% N50526 001 APR CTEC
>A> + 1.5% N50526 001 APR CTEC
ETHINYL ESTRADIOL; LEVONORGESTREL
TABLET; ORAL-21
LEVONORGESTREL AND ETHINYL ESTRADIOL
>A> AB1 BARR 0.02MG;0.1MG N75862 001 APR 29, 2003 APR NEWA
TABLET; ORAL-28
>A> AB1 BARR 0.02MG;0.1MG N75862 002 APR 29, 2003 APR NEWA
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
TABLET; ORAL-21
ESTROSTEP 21
>A> @ GALEN CHEM 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG N20130 001 OCT 09, 1996 APR CAHN
>D> @ PARKE DAVIS 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG N20130 001 OCT 09, 1996 APR CAHN
LOESTRIN 21 1.5/30
>A> + GALEN CHEM 0.03MG;1.5MG N17875 001 APR CAHN
>D> + PARKE DAVIS 0.03MG;1.5MG N17875 001 APR CAHN
LOESTRIN 21 1/20
>A> + GALEN CHEM 0.02MG;1MG N17876 001 APR CAHN
>D> + PARKE DAVIS 0.02MG;1MG N17876 001 APR CAHN
TABLET; ORAL-28
ESTROSTEP FE
>A> + GALEN CHEM 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG N20130 002 OCT 09, 1996 APR CAHN
>D> + PARKE DAVIS 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG N20130 002 OCT 09, 1996 APR CAHN
LOESTRIN FE 1.5/30
>A> AB + GALEN CHEM 0.03MG;1.5MG N17355 001 APR CAHN
>D> AB + PARKE DAVIS 0.03MG;1.5MG N17355 001 APR CAHN
LOESTRIN FE 1/20
>A> AB + GALEN CHEM 0.02MG;1MG N17354 001 APR CAHN
>D> AB + PARKE DAVIS 0.02MG;1MG N17354 001 APR CAHN
FLUVOXAMINE MALEATE
TABLET; ORAL
FLUVOXAMINE MALEATE
>A> AB GENEVA PHARMS 25MG N75887 001 JAN 05, 2001 APR CAHN
>A> AB 50MG N75887 002 JAN 05, 2001 APR CAHN
>A> AB 100MG N75887 003 JAN 05, 2001 APR CAHN
>D> AB INVAMED 25MG N75887 001 JAN 05, 2001 APR CAHN
>D> AB 50MG N75887 002 JAN 05, 2001 APR CAHN
>D> AB 100MG N75887 003 JAN 05, 2001 APR CAHN
GALANTAMINE HYDROBROMIDE
TABLET; ORAL
REMINYL
>D> JANSSEN PHARMA EQ 4MG BASE N21169 001 FEB 28, 2001 APR CRLD
>A> + EQ 4MG BASE N21169 001 FEB 28, 2001 APR CRLD
>D> + EQ 12MG BASE N21169 003 FEB 28, 2001 APR CRLD
>A> EQ 12MG BASE N21169 003 FEB 28, 2001 APR CRLD
GATIFLOXACIN
INJECTABLE; INJECTION
TEQUIN
>D> BRISTOL MYERS SQUIBB EQ 2MG /ML(200MG/100ML) N21062 001 DEC 17, 1999 APR CRLD
>D> EQ 2MG /ML(400MG/200ML) N21062 002 DEC 17, 1999 APR CRLD
>A> + EQ 2MG /ML(200MG/100ML) N21062 001 DEC 17, 1999 APR CRLD
>A> + EQ 2MG /ML(400MG/200ML) N21062 002 DEC 17, 1999 APR CRLD
>D> EQ 10MG /ML(200MG) N21062 003 DEC 17, 1999 APR CRLD
>A> + EQ 10MG /ML(200MG) N21062 003 DEC 17, 1999 APR CRLD
>A> GEMIFLOXACIN MESYLATE
>A> TABLET; ORAL
>A> FACTIVE
>A> + LG LIFE EQ 320MG BASE N21158 001 APR 04, 2003 APR NEWA
GENTAMICIN SULFATE
OINTMENT; OPHTHALMIC
>D> GARAMYCIN
>D> AT + SCHERING EQ 0.3% BASE N50425 001 APR DISC
>A> @ EQ 0.3% BASE N50425 001 APR DISC
GENTAMICIN SULFATE
>D> AT AKORN EQ 0.3% BASE N64093 001 AUG 31, 1995 APR CRLD
>A> + EQ 0.3% BASE N64093 001 AUG 31, 1995 APR CRLD
HYDROCODONE BITARTRATE; IBUPROFEN
TABLET; ORAL
>A> HYDROCODONE BITARTRATE AND IBUPROFEN
>A> AB TEVA 7.5MG;200MG N76023 001 APR 11, 2003 APR NEWA
VICOPROFEN
>D> + ABBOTT 7.5MG;200MG N20716 001 SEP 23, 1997 APR CFTG
>A> AB + 7.5MG;200MG N20716 001 SEP 23, 1997 APR CFTG
>D> HYDROCORTISONE SODIUM PHOSPHATE
>D> INJECTABLE; INJECTION
>D> HYDROCORTONE
>D> + MERCK EQ 50MG BASE/ML N12052 001 APR DISC
>A> @ EQ 50MG BASE/ML N12052 001 APR DISC
HYDROMORPHONE HYDROCHLORIDE
INJECTABLE; INJECTION
HYDROMORPHONE HCL
>A> AP FAULDING 10MG/ML N76444 001 APR 25, 2003 APR NEWA
IMATINIB MESYLATE
>A> TABLET; ORAL
>A> GLEEVEC
>A> NOVARTIS 100MG N21588 001 APR 18, 2003 APR NEWA
>A> + 400MG N21588 002 APR 18, 2003 APR NEWA
IPRATROPIUM BROMIDE
SPRAY, METERED; NASAL
IPRATROPIUM BROMIDE
>A> AB NOVEX 0.021MG/SPRAY N76156 001 APR 18, 2003 APR NEWA
>A> AB 0.042MG/SPRAY N76155 001 APR 18, 2003 APR NEWA
ISOTRETINOIN
CAPSULE; ORAL
CLARAVIS
>A> AB BARR 10MG N76356 001 APR 11, 2003 APR NEWA
>A> AB 20MG N76135 002 APR 11, 2003 APR NEWA
>A> AB 40MG N76135 001 APR 11, 2003 APR NEWA
LEVOTHYROXINE SODIUM
TABLET; ORAL
LEVO-T
>A> BX ALARA PHARM 0.025MG N21342 001 MAR 01, 2002 APR CAHN
>A> BX 0.05MG N21342 002 MAR 01, 2002 APR CAHN
>A> BX 0.075MG N21342 003 MAR 01, 2002 APR CAHN
>A> BX 0.088MG N21342 004 MAR 01, 2002 APR CAHN
>A> BX 0.1MG N21342 005 MAR 01, 2002 APR CAHN
>A> BX 0.112MG N21342 006 MAR 01, 2002 APR CAHN
>A> BX 0.125MG N21342 007 MAR 01, 2002 APR CAHN
>A> BX 0.15MG N21342 008 MAR 01, 2002 APR CAHN
>A> BX 0.175MG N21342 009 MAR 01, 2002 APR CAHN
>A> BX 0.2MG N21342 010 MAR 01, 2002 APR CAHN
>A> BX + 0.3MG N21342 011 MAR 01, 2002 APR CAHN
>D> BX MOVA 0.025MG N21342 001 MAR 01, 2002 APR CAHN
>D> BX 0.05MG N21342 002 MAR 01, 2002 APR CAHN
>D> BX 0.075MG N21342 003 MAR 01, 2002 APR CAHN
>D> BX 0.088MG N21342 004 MAR 01, 2002 APR CAHN
>D> BX 0.1MG N21342 005 MAR 01, 2002 APR CAHN
>D> BX 0.112MG N21342 006 MAR 01, 2002 APR CAHN
>D> BX 0.125MG N21342 007 MAR 01, 2002 APR CAHN
>D> BX 0.15MG N21342 008 MAR 01, 2002 APR CAHN
>D> BX 0.175MG N21342 009 MAR 01, 2002 APR CAHN
>D> BX 0.2MG N21342 010 MAR 01, 2002 APR CAHN
>D> BX + 0.3MG N21342 011 MAR 01, 2002 APR CAHN
LISINOPRIL
TABLET; ORAL
ZESTRIL
>D> AB + ASTRAZENECA 30MG N19777 006 JAN 20, 1999 APR CRLD
>A> AB 30MG N19777 006 JAN 20, 1999 APR CRLD
LITHIUM CARBONATE
TABLET, EXTENDED RELEASE; ORAL
LITHIUM CARBONATE
>A> AB ABLE 300MG N76382 001 APR 21, 2003 APR NEWA
MECAMYLAMINE HYDROCHLORIDE
TABLET; ORAL
INVERSINE
>D> + LAYTON 2.5MG N10251 001 APR CAHN
>A> + TARGACEPT 2.5MG N10251 001 APR CAHN
MEFLOQUINE HYDROCHLORIDE
TABLET; ORAL
MEFLOQUINE HCL
>A> AB GENEVA PHARMS 250MG N76175 001 FEB 20, 2002 APR CAHN
>D> AB GENEVA PHARMS TECH 250MG N76175 001 FEB 20, 2002 APR CAHN
MEPROBAMATE
TABLET; ORAL
MILTOWN
>A> AA + MEDPOINTE 600MG N83919 001 APR CAHN
>D> AA + WALLACE PHARMS 600MG N83919 001 APR CAHN
METFORMIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
GLUCOPHAGE XR
>A> + BRISTOL MYERS SQUIBB 750MG N21202 004 APR 11, 2003 APR NEWA
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
TABLET; ORAL
AVANDAMET
>D> GLAXOSMITHKLINE 500MG;EQ 1MG BASE N21410 001 OCT 10, 2002 APR CAHN
>D> 500MG;EQ 2MG BASE N21410 002 OCT 10, 2002 APR CAHN
>D> + 500MG;EQ 4MG BASE N21410 003 OCT 10, 2002 APR CAHN
>A> SB PHARMCO 500MG;EQ 1MG BASE N21410 001 OCT 10, 2002 APR CAHN
>A> + 500MG;EQ 4MG BASE N21410 003 OCT 10, 2002 APR CAHN
>A> 500MG;EQ 2MG BASE N21410 002 OCT 10, 2002 APR CAHN
METHADONE HYDROCHLORIDE
INJECTABLE; INJECTION
DOLOPHINE HCL
>A> + AAIPHARMA 10MG/ML N21624 001 APR CAHN
>D> + ROXANE 10MG/ML N21624 001 APR CAHN
METHYLPHENIDATE HYDROCHLORIDE
>A> TABLET, CHEWABLE; ORAL
>A> METHYLIN
>A> MALLINCKRODT 2.5MG N21475 001 APR 15, 2003 APR NEWA
>A> 5MG N21475 002 APR 15, 2003 APR NEWA
>A> + 10MG N21475 003 APR 15, 2003 APR NEWA
METOCLOPRAMIDE HYDROCHLORIDE
SOLUTION; ORAL
METOCLOPRAMIDE
>D> AA UDL EQ 5MG BASE/5ML N75051 001 JAN 26, 2001 APR CAHN
>A> AA VISTAPHARM EQ 5MG BASE/5ML N75051 001 JAN 26, 2001 APR CAHN
MINOCYCLINE HYDROCHLORIDE
>A> TABLET; ORAL
>A> MINOCYCLINE HCL
>A> PAR PHARM EQ 50MG BASE N65131 001 APR 16, 2003 APR NEWA
>A> EQ 75MG BASE N65131 002 APR 16, 2003 APR NEWA
>A> + EQ 100MG BASE N65131 003 APR 16, 2003 APR NEWA
MOXIFLOXACIN HYDROCHLORIDE
>A> SOLUTION/DROPS; OPHTHALMIC
>A> VIGAMOX
>A> + ALCON 0.5% N21598 001 APR 15, 2003 APR NEWA
MUPIROCIN
OINTMENT; TOPICAL
MUPIROCIN
>D> BX CLAY PARK LABS 2% N50788 001 DEC 04, 2002 APR CAHN
>A> BX JOHNSON AND JOHNSON 2% N50788 001 DEC 04, 2002 APR CAHN
NAPROXEN SODIUM
TABLET, EXTENDED RELEASE; ORAL
NAPRELAN
>D> + ELAN PHARM EQ 375MG BASE N20353 001 JAN 05, 1996 APR CFTG
>A> AB + EQ 375MG BASE N20353 001 JAN 05, 1996 APR CFTG
>A> NAPROXEN SODIUM
>A> AB ANDRX PHARMS EQ 375MG BASE N75416 002 APR 23, 2003 APR NEWA
NELFINAVIR MESYLATE
TABLET; ORAL
VIRACEPT
>A> + AGOURON EQ 625MG BASE N21503 001 APR 30, 2003 APR NEWA
NITROFURANTOIN
>D> TABLET; ORAL
>D> FURADANTIN
>D> AB PROCTER AND GAMBLE 50MG N08693 001 APR DISC
>A> @ 50MG N08693 001 APR DISC
>D> AB + 100MG N08693 002 APR DISC
>A> @ 100MG N08693 002 APR DISC
>D> NITROFURANTOIN
>D> AB WATSON LAB 50MG N80447 001 APR DISC
>A> @ 50MG N80447 001 APR DISC
>D> AB WHITEWORTH TOWN PLSN 100MG N84085 002 APR DISC
>A> @ 100MG N84085 002 APR DISC
NITROGLYCERIN
FILM, EXTENDED RELEASE; TRANSDERMAL
NITROGLYCERIN
>D> AB2 MYLAN 0.1MG/HR N75033 001 FEB 06, 1998 APR CAHN
>D> AB2 0.2MG/HR N74609 001 AUG 30, 1996 APR CAHN
>D> AB2 0.4MG/HR N74607 001 AUG 30, 1996 APR CAHN
>D> AB2 0.6MG/HR N74559 001 AUG 30, 1996 APR CAHN
>A> AB2 MYLAN TECHNOLOGIES 0.1MG/HR N75033 001 FEB 06, 1998 APR CAHN
>A> AB2 0.2MG/HR N74609 001 AUG 30, 1996 APR CAHN
>A> AB2 0.4MG/HR N74607 001 AUG 30, 1996 APR CAHN
>A> AB2 0.6MG/HR N74559 001 AUG 30, 1996 APR CAHN
OINTMENT; TRANSDERMAL
>D> + ALTANA 2% N87355 001 JUL 08, 1988 APR CAHN
>A> + FOUGERA 2% N87355 001 JUL 08, 1988 APR CAHN
PANTOPRAZOLE SODIUM
TABLET, DELAYED RELEASE; ORAL
PROTONIX
>D> + WYETH PHARMS INC EQ 20MG BASE N20987 002 JUN 12, 2001 APR CRLD
>A> EQ 20MG BASE N20987 002 JUN 12, 2001 APR CRLD
PERMETHRIN
CREAM; TOPICAL
PERMETHRIN
>A> AB CLAY PARK 5% N76369 001 APR 21, 2003 APR NEWA
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP; ORAL
>D> PHENERGAN VC
>D> AA + WYETH AYERST 5MG/5ML;6.25MG/5ML N08604 003 APR 02, 1984 APR DISC
>A> @ 5MG/5ML;6.25MG/5ML N08604 003 APR 02, 1984 APR DISC
PROMETH VC PLAIN
>D> AA ALPHARMA 5MG/5ML;6.25MG/5ML N88761 001 NOV 08, 1984 APR CRLD
>A> AA + 5MG/5ML;6.25MG/5ML N88761 001 NOV 08, 1984 APR CRLD
PILOCARPINE HYDROCHLORIDE
TABLET; ORAL
SALAGEN
>D> + MGI PHARMA INC 5MG N20237 001 MAR 22, 1994 APR CRLD
>A> 5MG N20237 001 MAR 22, 1994 APR CRLD
>A> + 7.5MG N20237 002 APR 18, 2003 APR NEWA
PREDNICARBATE
CREAM; TOPICAL
DERMATOP E EMOLLIENT
>D> + DERMIK LABS 0.1% N20279 001 OCT 29, 1993 APR CTNA
>A> + 0.1% N20279 001 OCT 29, 1993 APR CTNA
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
SOLUTION/DROPS; OPHTHALMIC
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
>A> AT ALCON EQ 0.23% PHOSPHATE;10% N73630 001 MAY 27, 1993 APR CAHN
>D> AT ALCON UNIVERSAL EQ 0.23% PHOSPHATE;10% N73630 001 MAY 27, 1993 APR CAHN
PROMETHAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
>D> PHENERGAN
>D> AP + WYETH AYERST 50MG/ML N08857 003 APR DISC
>A> @ 50MG/ML N08857 003 APR DISC
PROMETHAZINE HCL
>D> AP GENSIA SICOR PHARMS 25MG/ML N40454 001 AUG 22, 2002 APR CRLD
>A> AP + 25MG/ML N40454 001 AUG 22, 2002 APR CRLD
>D> AP 50MG/ML N40454 002 AUG 22, 2002 APR CRLD
>A> AP + 50MG/ML N40454 002 AUG 22, 2002 APR CRLD
SUPPOSITORY; RECTAL
>A> AB ABLE 12.5MG N40504 001 APR 11, 2003 APR NEWA
>A> AB 25MG N40504 002 APR 11, 2003 APR NEWA
PYRIDOSTIGMINE BROMIDE
TABLET; ORAL
PYRIDOSTIGMINE BROMIDE
>A> AB IMPAX LABS 60MG N40502 001 APR 24, 2003 APR NEWA
QUINIDINE GLUCONATE
TABLET, EXTENDED RELEASE; ORAL
QUINIDINE GLUCONATE
>D> BX MUTUAL PHARM 324MG N89338 001 FEB 11, 1987 APR CRLD
>A> BX + 324MG N89338 001 FEB 11, 1987 APR CRLD
>D> + WATSON LABS 324MG N87810 001 SEP 29, 1982 APR CRLD
>A> BX 324MG N87810 001 SEP 29, 1982 APR CRLD
RISPERIDONE
>A> TABLET, ORALLY DISINTEGRATING; ORAL
>A> RISPERDAL
>A> JOHNSON AND JOHNSON 0.5MG N21444 001 APR 02, 2003 APR NEWA
>A> + 1MG N21444 002 APR 02, 2003 APR NEWA
>A> 2MG N21444 003 APR 02, 2003 APR NEWA
ROSIGLITAZONE MALEATE
TABLET; ORAL
AVANDIA
>D> GLAXOSMITHKLINE EQ 2MG BASE N21071 002 MAY 25, 1999 APR CAHN
>D> EQ 4MG BASE N21071 003 MAY 25, 1999 APR CAHN
>D> + EQ 8MG BASE N21071 004 MAY 25, 1999 APR CAHN
>A> SB PHARMCO EQ 2MG BASE N21071 002 MAY 25, 1999 APR CAHN
>A> EQ 4MG BASE N21071 003 MAY 25, 1999 APR CAHN
>A> + EQ 8MG BASE N21071 004 MAY 25, 1999 APR CAHN
SEVELAMER HYDROCHLORIDE
CAPSULE; ORAL
RENAGEL
>D> + GELTEX 403MG N20926 001 OCT 30, 1998 APR CAHN
>A> + GENZYME 403MG N20926 001 OCT 30, 1998 APR CAHN
TABLET; ORAL
>D> GELTEX 400MG N21179 001 JUL 12, 2000 APR CAHN
>D> + 800MG N21179 002 JUL 12, 2000 APR CAHN
>A> GENZYME 400MG N21179 001 JUL 12, 2000 APR CAHN
>A> + 800MG N21179 002 JUL 12, 2000 APR CAHN
SOTALOL HYDROCHLORIDE
TABLET; ORAL
BETAPACE AF
>A> BERLEX LABS 40MG N21151 006 APR 02, 2003 APR NEWA
>A> 60MG N21151 007 APR 02, 2003 APR NEWA
TAMOXIFEN CITRATE
TABLET; ORAL
TAMOXIFEN CITRATE
>A> AB PHARMACHEMIE EQ 10MG BASE N74539 001 MAR 31, 2003 APR CAHN
>A> AB TEVA EQ 10MG BASE N74504 001 APR 28, 2003 APR NEWA
>D> AB EQ 10MG BASE N74539 001 MAR 31, 2003 APR CAHN
>A> AB EQ 20MG BASE N74504 002 APR 28, 2003 APR NEWA
TESTOSTERONE
GEL; TOPICAL
ANDROGEL
>D> + UNIMED PHARMS 1% N21015 001 FEB 28, 2000 APR CTEC
>A> BX + 1% N21015 001 FEB 28, 2000 APR CTEC
TESTIM
>D> + AUXILIUM A2 1% N21454 001 OCT 31, 2002 APR CTEC
>A> BX + 1% N21454 001 OCT 31, 2002 APR CTEC
TIZANIDINE HYDROCHLORIDE
TABLET; ORAL
TIZANIDINE HCL
>A> AB BARR EQ 2MG BASE N76371 001 APR 09, 2003 APR NEWA
>A> AB EQ 4MG BASE N76371 002 APR 09, 2003 APR NEWA
TRIAMCINOLONE ACETONIDE
LOTION; TOPICAL
TRIAMCINOLONE ACETONIDE
>A> AT ALTANA 0.025% N40467 001 APR 21, 2003 APR NEWA
>A> AT 0.1% N40467 002 APR 21, 2003 APR NEWA
LORATADINE
SYRUP; ORAL
CLARITIN
>D> SCHERING 1MG/ML N20641 002 NOV 27, 2002 APR CRLD
>A> + 1MG/ML N20641 002 NOV 27, 2002 APR CRLD
TABLET; ORAL
>D> SCHERING 10MG N19658 002 NOV 27, 2002 APR CRLD
>A> + 10MG N19658 002 NOV 27, 2002 APR CRLD
TABLET, ORALLY DISINTEGRATING; ORAL
ALAVERT
>D> + WYETH CONS 10MG N21375 001 DEC 19, 2002 APR CRLD
>A> 10MG N21375 001 DEC 19, 2002 APR CRLD
CLARITIN REDITABS
>D> SCHERING 10MG N20704 002 NOV 27, 2002 APR CRLD
>A> + 10MG N20704 002 NOV 27, 2002 APR CRLD
LORATADINE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE; ORAL
CLARITIN-D
>D> SCHERING 5MG;120MG N19670 002 NOV 27, 2002 APR CRLD
>A> + 5MG;120MG N19670 002 NOV 27, 2002 APR CRLD
CLARITIN-D 24 HOUR
>D> SCHERING 10MG;240MG N20470 002 NOV 27, 2002 APR CRLD
>A> + 10MG;240MG N20470 002 NOV 27, 2002 APR CRLD
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FDA/Center for Drug Evaluation and Research
Last Updated: March 18, 2003
Originator: OIT/DDMS
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