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
BUTALBITAL, APAP, AND CAFFEINE
>A> AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN
>D> AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN
ACETAMINOPHEN; HYDROCODONE BITARTRATE
TABLET; ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
>A> AA ABLE 500MG;7.5MG N40490 001 MAY 21, 2003 MAY NEWA
>A> AA ANDRX PHARMS 500MG;5MG N40493 001 MAY 28, 2003 MAY NEWA
>A> AA 660MG;10MG N40495 001 MAY 28, 2003 MAY NEWA
>A> AA 750MG;7.5MG N40494 001 MAY 28, 2003 MAY NEWA
>A> AA AXIOM PHARM 500MG;5MG N40236 001 SEP 25, 1997 MAY CAHN
>A> AA 650MG;10MG N40240 001 NOV 26, 1997 MAY CAHN
>A> AA 650MG;7.5MG N40240 002 NOV 26, 1997 MAY CAHN
>A> AA 750MG;7.5MG N40236 002 SEP 25, 1997 MAY CAHN
>D> AA HALSEY 500MG;5MG N40236 001 SEP 25, 1997 MAY CAHN
>D> AA 650MG;10MG N40240 001 NOV 26, 1997 MAY CAHN
>D> AA 650MG;7.5MG N40240 002 NOV 26, 1997 MAY CAHN
>D> AA 750MG;7.5MG N40236 002 SEP 25, 1997 MAY CAHN
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
CAPSULE; ORAL
OXYCODONE AND ACETAMINOPHEN
>A> AA AXIOM PHARM 500MG;5MG N40219 001 JAN 22, 1998 MAY CAHN
>D> AA HALSEY 500MG;5MG N40219 001 JAN 22, 1998 MAY CAHN
AMCINONIDE
CREAM; TOPICAL
AMCINONIDE
>A> AB ALTANA 0.1% N76065 001 MAY 15, 2003 MAY NEWA
>D> AT TARO PHARM INDS 0.1% N76229 001 MAY 31, 2002 MAY CTEC
>A> AB 0.1% N76229 001 MAY 31, 2002 MAY CTEC
CYCLOCORT
>D> AT + FUJISAWA HLTHCARE 0.1% N18116 002 MAY CTEC
>A> AB + 0.1% N18116 002 MAY CTEC
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS; ORAL
PREVPAC
>D> + TAP PHARM 500MG;500MG;30MG N50757 001 DEC 02, 1997 MAY CDFR
>A> + 500MG;500MG;30MG N50757 001 DEC 02, 1997 MAY CDFR
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;
DEXTROAMPHETAMINE SULFATE
TABLET; ORAL
DEXTROAMP SACCHARATE, AMP ASPARATE, DEXTROAMP SULFATE AND AMP SULFATE
>A> AB WATSON LABS 1.25MG;1.25MG;1.25MG;1.25MG N40456 001 MAY 06, 2003 MAY NEWA
>A> AB 2.5MG;2.5MG;2.5MG;2.5MG N40456 002 MAY 06, 2003 MAY NEWA
>A> AB 5MG;5MG;5MG;5MG N40456 003 MAY 06, 2003 MAY NEWA
>A> AB 7.5MG;7.5MG;7.5MG;7.5MG N40456 004 MAY 06, 2003 MAY NEWA
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
TABLET; ORAL
OXYCODONE AND ASPIRIN
>A> AA AXIOM PHARM 325MG;4.5MG;0.38MG N40260 001 JUL 17, 1998 MAY CAHN
>D> AA HALSEY 325MG;4.5MG;0.38MG N40260 001 JUL 17, 1998 MAY CAHN
ATOMOXETINE HYDROCHLORIDE
CAPSULE; ORAL
STRATTERA
>D> LILLY 5MG N21411 001 NOV 26, 2002 MAY DISC
>A> @ 5MG N21411 001 NOV 26, 2002 MAY DISC
BETAMETHASONE DIPROPIONATE
CREAM; TOPICAL
ALPHATREX
>D> AB SAVAGE LABS EQ 0.05% BASE N19138 001 JUN 26, 1984 MAY CRLD
>A> AB + EQ 0.05% BASE N19138 001 JUN 26, 1984 MAY CRLD
>D> DIPROSONE
>D> AB + SCHERING EQ 0.05% BASE N17536 001 MAY DISC
>A> @ EQ 0.05% BASE N17536 001 MAY DISC
GEL, AUGMENTED; TOPICAL
>A> BETAMETHASONE DIPROPIONATE
>A> AB ALTANA EQ 0.05% BASE N75276 001 MAY 13, 2003 MAY NEWA
DIPROLENE
>D> + SCHERING EQ 0.05% BASE N19408 002 NOV 22, 1991 MAY CFTG
>A> AB + EQ 0.05% BASE N19408 002 NOV 22, 1991 MAY CFTG
>A> BORTEZOMIB
>A> INJECTABLE; INTRAVENOUS
>A> VELCADE
>A> + MILLENNIUM PHARMS 3.5MG/VIAL N21602 001 MAY 13, 2003 MAY NEWA
BRIMONIDINE TARTRATE
SOLUTION/DROPS; OPHTHALMIC
>A> BRIMONIDINE TARTRATE
>A> + BAUSCH AND LOMB 0.2% N76260 001 MAY 28, 2003 MAY NEWA
>A> BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE
>A> INJECTABLE; INJECTION
>A> DUOCAINE
>A> + AMPAHSTAR EQ 0.375% (37.5MG/10ML);EQ 1%
(100MG/10ML) N21496 001 MAY 23, 2003 MAY NEWA
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;
SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE; INTRATHECAL
ELLIOTTS B SOLUTION
>D> + ORPHAN MEDCL 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML
;1.9MG/ML;7.3MG/ML;0.2MG/ML N20577 001 SEP 27, 1996 MAY CAHN
>A> + QOL MEDCL 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML
;1.9MG/ML;7.3MG/ML;0.2MG/ML N20577 001 SEP 27, 1996 MAY CAHN
CEFDITOREN PIVOXIL
TABLET; ORAL
SPECTRACEF
>A> + PURDUE PHARMA LP 200MG N21222 001 AUG 29, 2001 MAY CAHN
>D> + TAP PHARM 200MG N21222 001 AUG 29, 2001 MAY CAHN
CHLORAMPHENICOL
OINTMENT; OPHTHALMIC
CHLORAMPHENICOL
>D> AT ALTANA 1% N60133 001 MAY CRLD
>A> AT + 1% N60133 001 MAY CRLD
>D> CHLOROMYCETIN
>D> AT + PARKEDALE 1% N50156 001 MAY DISC
>A> @ 1% N50156 001 MAY DISC
SOLUTION/DROPS; OTIC
>D> + PARKEDALE 0.5% N50205 001 MAY DISC
>A> @ 0.5% N50205 001 MAY DISC
>D> CHLOROTHIAZIDE; METHYLDOPA
>D> TABLET; ORAL
>D> ALDOCLOR-150
>D> MERCK 150MG;250MG N16016 001 MAY DISC
>A> @ 150MG;250MG N16016 001 MAY DISC
>D> ALDOCLOR-250
>D> + MERCK 250MG;250MG N16016 002 MAY DISC
>A> @ 250MG;250MG N16016 002 MAY DISC
CHLORTHALIDONE
TABLET; ORAL
THALITONE
>D> BX MONARCH PHARMS 25MG N19574 002 FEB 12, 1992 MAY DISC
>A> @ 25MG N19574 002 FEB 12, 1992 MAY DISC
COLESTIPOL HYDROCHLORIDE
TABLET; ORAL
COLESTID
>D> PHARMACIA AND UPJOHN 1GM N20222 001 JUL 19, 1994 MAY CRLD
>A> + 1GM N20222 001 JUL 19, 1994 MAY CRLD
CROMOLYN SODIUM
SOLUTION/DROPS; OPHTHALMIC
>D> CROMOPTIC
>D> AT KING PHARMS 4% N75088 001 APR 27, 1999 MAY DISC
>A> @ 4% N75088 001 APR 27, 1999 MAY DISC
DESMOPRESSIN ACETATE
SPRAY, METERED; NASAL
DESMOPRESSIN ACETATE
>A> AB + FERRING 0.01MG/SPRAY N21333 001 SEP 16, 2002 MAY CMS1
>D> + 0.01MG/SPRAY N21333 001 SEP 16, 2002 MAY CMS1
>D> DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
>D> SOLUTION/DROPS; OPHTHALMIC
>D> NEODECADRON
>D> + MERCK EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML N50322 001 MAY DISC
>A> @ EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML N50322 001 MAY DISC
DEXTROAMPHETAMINE SULFATE
CAPSULE, EXTENDED RELEASE; ORAL
DEXTROAMPHETAMINE SULFATE
>A> AB MALLINCKRODT 5MG N76353 001 MAY 06, 2003 MAY NEWA
>A> AB 10MG N76353 002 MAY 06, 2003 MAY NEWA
>A> AB 15MG N76353 003 MAY 06, 2003 MAY NEWA
>D> DICHLORPHENAMIDE
>D> TABLET; ORAL
>D> DARANIDE
>D> + MERCK 50MG N11366 001 MAY DISC
>A> @ 50MG N11366 001 MAY DISC
>D> DILTIAZEM MALATE
>D> TABLET, EXTENDED RELEASE; ORAL
>D> TIAMATE
>D> + MERCK EQ 120MG HCL N20506 001 OCT 04, 1996 MAY DISC
>A> @ EQ 120MG HCL N20506 001 OCT 04, 1996 MAY DISC
>D> + EQ 180MG HCL N20506 002 OCT 04, 1996 MAY DISC
>A> @ EQ 180MG HCL N20506 002 OCT 04, 1996 MAY DISC
>D> + EQ 240MG HCL N20506 003 OCT 04, 1996 MAY DISC
>A> @ EQ 240MG HCL N20506 003 OCT 04, 1996 MAY DISC
DOXYCYCLINE
CAPSULE; ORAL
DOXYCYCLINE
>A> AB AXIOM PHARM EQ 50MG BASE N65041 001 APR 28, 2000 MAY CAHN
>A> AB EQ 100MG BASE N65041 002 APR 28, 2000 MAY CAHN
>D> AB HALSEY EQ 50MG BASE N65041 001 APR 28, 2000 MAY CAHN
>D> AB EQ 100MG BASE N65041 002 APR 28, 2000 MAY CAHN
DOXYCYCLINE HYCLATE
CAPSULE; ORAL
DOXYCYCLINE HYCLATE
>A> AB AXIOM PHARM EQ 50MG BASE N61717 001 MAY CAHN
>A> AB EQ 100MG BASE N61717 002 MAY CAHN
>D> AB HALSEY EQ 50MG BASE N61717 001 MAY CAHN
>D> AB EQ 100MG BASE N61717 002 MAY CAHN
TABLET; ORAL
>A> AB AXIOM PHARM EQ 100MG BASE N62269 002 NOV 08, 1982 MAY CAHN
>D> AB HALSEY EQ 100MG BASE N62269 002 NOV 08, 1982 MAY CAHN
DOXYCYCLINE HYLATE
>A> @ AXIOM PHARM EQ 50MG BASE N62269 003 MAY CAHN
>D> @ HALSEY EQ 50MG BASE N62269 003 MAY CAHN
EDROPHONIUM CHLORIDE
INJECTABLE; INJECTION
>D> REVERSOL
>D> AP ORGANON 10MG/ML N89624 001 MAY 13, 1988 MAY DISC
>A> @ 10MG/ML N89624 001 MAY 13, 1988 MAY DISC
EPINEPHRINE
>A> INJECTABLE; IM-SC
>A> TWINJECT
>A> + HOLLISTER STIER LABS EQ 0.3MG /DELIVERY N20800 001 MAY 30, 2003 MAY NEWA
>D> ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE
>D> INJECTABLE; INJECTION
>D> DEPO-TESTADIOL
>D> + PHARMACIA AND UPJOHN 2MG/ML;50MG/ML N17968 001 MAY WDGD
>A> @ 2MG/ML;50MG/ML N17968 001 MAY WDGD
ESTRADIOL; NORGESTIMATE
TABLET; ORAL
PREFEST
>D> + KING PHARMS 1MG;1MG;0.09MG N21040 001 OCT 22, 1999 MAY CTNA
>A> + 1MG;1MG;0.09MG N21040 001 OCT 22, 1999 MAY CTNA
ETHACRYNIC ACID
TABLET; ORAL
EDECRIN
>D> MERCK 25MG N16092 001 MAY CRLD
>A> + 25MG N16092 001 MAY CRLD
>D> + 50MG N16092 002 MAY DISC
>A> @ 50MG N16092 002 MAY DISC
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
TABLET; ORAL
FEMHRT
>A> + GALEN CHEM 0.005MG;1MG N21065 002 OCT 15, 1999 MAY CAHN
>D> + PFIZER PHARMS 0.005MG;1MG N21065 002 OCT 15, 1999 MAY CAHN
TABLET; ORAL-21
>A> JUNEL 1.5/30
>A> AB BARR 0.03MG;1.5MG N76381 001 MAY 30, 2003 MAY NEWA
>A> JUNEL 1/20
>A> AB BARR 0.02MG;1MG N76380 001 MAY 30, 2003 MAY NEWA
LOESTRIN 21 1.5/30
>D> + GALEN CHEM 0.03MG;1.5MG N17875 001 MAY CFTG
>A> AB + 0.03MG;1.5MG N17875 001 MAY CFTG
LOESTRIN 21 1/20
>D> + GALEN CHEM 0.02MG;1MG N17876 001 MAY CFTG
>A> AB + 0.02MG;1MG N17876 001 MAY CFTG
FLUOCINONIDE
CREAM; TOPICAL
FLUOCINONIDE
>D> AB ALPHARMA US PHARM 0.05% N73085 001 FEB 14, 1992 MAY CTEC
>A> AB1 0.05% N73085 001 FEB 14, 1992 MAY CTEC
>D> AB FOUGERA 0.05% N73030 001 OCT 17, 1994 MAY CTEC
>A> AB1 0.05% N73030 001 OCT 17, 1994 MAY CTEC
>D> AB TARO 0.05% N19117 001 JUN 26, 1984 MAY CTEC
>A> AB1 0.05% N19117 001 JUN 26, 1984 MAY CTEC
>D> AB 0.05% N71500 001 JUN 10, 1987 MAY CTEC
>A> AB1 0.05% N71500 001 JUN 10, 1987 MAY CTEC
>D> AB TEVA 0.05% N72488 001 FEB 06, 1989 MAY CTEC
>A> AB1 0.05% N72488 001 FEB 06, 1989 MAY CTEC
FLUOCINONIDE EMULSIFIED BASE
>D> AB ALPHARMA US PHARM 0.05% N74204 001 JUN 13, 1995 MAY CTEC
>A> AB2 0.05% N74204 001 JUN 13, 1995 MAY CTEC
>D> AB DRAXIS HLTH 0.05% N72494 001 JAN 19, 2089 MAY CTEC
>A> AB2 0.05% N72494 001 JAN 19, 2089 MAY CTEC
>D> AB TEVA 0.05% N72490 001 FEB 07, 1989 MAY CTEC
>A> AB2 0.05% N72490 001 FEB 07, 1989 MAY CTEC
LIDEX
>D> AB + MEDICIS 0.05% N16908 002 MAY CTEC
>A> AB1 + 0.05% N16908 002 MAY CTEC
LIDEX-E
>D> AB MEDICIS 0.05% N16908 003 MAY CRLD
>A> AB2 + 0.05% N16908 003 MAY CRLD
FLUPHENAZINE DECANOATE
INJECTABLE; INJECTION
FLUPHENAZINE DECANOATE
>D> AO KING PHARMS 25MG/ML N74966 001 APR 16, 1998 MAY DISC
>A> @ 25MG/ML N74966 001 APR 16, 1998 MAY DISC
FLURANDRENOLIDE
LOTION; TOPICAL
CORDRAN
>D> AT + OCLASSEN 0.05% N13790 001 MAY CTEC
>A> + 0.05% N13790 001 MAY CTEC
FLUTAMIDE
CAPSULE; ORAL
FLUTAMIDE
>A> AB GENPHARM 125MG N76224 001 MAY 09, 2003 MAY NEWA
>A> GEFITINIB
>A> TABLET; ORAL
>A> IRESSA
>A> + ASTRAZENECA 250MG N21399 001 MAY 05, 2003 MAY NEWA
GEMIFLOXACIN MESYLATE
TABLET; ORAL
FACTIVE
>A> + GENESOFT PHARMS EQ 320MG BASE N21158 001 APR 04, 2003 MAY CAHN
>D> + LG LIFE EQ 320MG BASE N21158 001 APR 04, 2003 MAY CAHN
GONADORELIN HYDROCHLORIDE
INJECTABLE; INJECTION
FACTREL
>A> + BAXTER HLTHCARE CORP EQ 0.1MG BASE/VIAL N18123 001 SEP 30, 1982 MAY CAHN
>A> @ EQ 0.2MG BASE/VIAL N18123 002 SEP 30, 1982 MAY CAHN
>A> @ EQ 0.5MG BASE/VIAL N18123 003 SEP 30, 1982 MAY CAHN
>D> + WYETH AYERST EQ 0.1MG BASE/VIAL N18123 001 SEP 30, 1982 MAY CAHN
>D> @ EQ 0.2MG BASE/VIAL N18123 002 SEP 30, 1982 MAY CAHN
>D> @ EQ 0.5MG BASE/VIAL N18123 003 SEP 30, 1982 MAY CAHN
>D> GREPAFLOXACIN HYDROCHLORIDE
>D> TABLET; ORAL
>D> RAXAR
>D> OTSUKA EQ 200MG BASE N20695 001 NOV 06, 1997 MAY DISC
>A> @ EQ 200MG BASE N20695 001 NOV 06, 1997 MAY DISC
>D> EQ 400MG BASE N20695 002 MAY 14, 1998 MAY DISC
>A> @ EQ 400MG BASE N20695 002 MAY 14, 1998 MAY DISC
>D> + EQ 600MG BASE N20695 003 MAY 14, 1998 MAY DISC
>A> @ EQ 600MG BASE N20695 003 MAY 14, 1998 MAY DISC
HALOPERIDOL DECANOATE
INJECTABLE; INJECTION
HALOPERIDOL DECANOATE
>D> AO KING PHARMS EQ 50MG BASE/ML N75176 001 FEB 09, 2000 MAY DISC
>A> @ EQ 50MG BASE/ML N75176 001 FEB 09, 2000 MAY DISC
>D> AO EQ 100MG BASE/ML N75176 002 FEB 09, 2000 MAY DISC
>A> @ EQ 100MG BASE/ML N75176 002 FEB 09, 2000 MAY DISC
HEPARIN SODIUM
INJECTABLE; INJECTION
HEPARIN LOCK FLUSH
>A> @ BAXTER HLTHCARE CORP 10 UNITS/ML N17007 008 MAY CAHN
>A> @ 100 UNITS/ML N17007 009 MAY CAHN
>D> @ WYETH AYERST 10 UNITS/ML N17007 008 MAY CAHN
>D> @ 100 UNITS/ML N17007 009 MAY CAHN
HEPARIN SODIUM
>A> @ BAXTER HLTHCARE CORP 1,000 UNITS/ML N17007 001 MAY CAHN
>A> @ 2,500 UNITS/ML N17007 007 MAY CAHN
>A> @ 5,000 UNITS/ML N17007 002 MAY CAHN
>A> @ 5,000 UNITS/0.5ML N17007 010 MAY CAHN
>A> @ 7,500 UNITS/ML N17007 003 MAY CAHN
>A> @ 10,000 UNITS/ML N17007 004 MAY CAHN
>A> @ 15,000 UNITS/ML N17007 005 MAY CAHN
>A> @ 20,000 UNITS/ML N17007 006 MAY CAHN
>D> @ WYETH AYERST 1,000 UNITS/ML N17007 001 MAY CAHN
>D> @ 2,500 UNITS/ML N17007 007 MAY CAHN
>D> @ 5,000 UNITS/ML N17007 002 MAY CAHN
>D> @ 5,000 UNITS/0.5ML N17007 010 MAY CAHN
>D> @ 7,500 UNITS/ML N17007 003 MAY CAHN
>D> @ 10,000 UNITS/ML N17007 004 MAY CAHN
>D> @ 15,000 UNITS/ML N17007 005 MAY CAHN
>D> @ 20,000 UNITS/ML N17007 006 MAY CAHN
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
SYRUP; ORAL
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
>A> AA AXIOM PHARM 1.5MG/5ML;5MG/5ML N40285 001 JUL 19, 1999 MAY CAHN
>D> AA HALSEY 1.5MG/5ML;5MG/5ML N40285 001 JUL 19, 1999 MAY CAHN
>A> IBANDRONATE SODIUM
>A> TABLET; ORAL
>A> BONIVA
>A> + ROCHE EQ 2.5MG BASE N21455 001 MAY 16, 2003 MAY NEWA
ISONIAZID
TABLET; ORAL
ISONIAZID
>A> @ AXIOM PHARM 100MG N80136 001 MAY CAHN
>A> AA 300MG N83633 001 MAY CAHN
>D> @ HALSEY 100MG N80136 001 MAY CAHN
>D> AA 300MG N83633 001 MAY CAHN
ISRADIPINE
CAPSULE; ORAL
DYNACIRC
>D> NOVARTIS 2.5MG N19546 001 DEC 20, 1990 MAY CAHN
>D> + 5MG N19546 002 DEC 20, 1990 MAY CAHN
>A> RELIANT PHARMS 2.5MG N19546 001 DEC 20, 1990 MAY CAHN
>A> + 5MG N19546 002 DEC 20, 1990 MAY CAHN
TABLET, EXTENDED RELEASE; ORAL
DYNACIRC CR
>D> + NOVARTIS 5MG N20336 001 JUN 01, 1994 MAY CAHN
>D> + 10MG N20336 002 JUN 01, 1994 MAY CAHN
>A> + RELIANT PHARMS 5MG N20336 001 JUN 01, 1994 MAY CAHN
>A> + 10MG N20336 002 JUN 01, 1994 MAY CAHN
KETOROLAC TROMETHAMINE
SOLUTION/DROPS; OPHTHALMIC
>A> ACULAR LS
>A> + ALLERGAN 0.4% N21528 001 MAY 30, 2003 MAY NEWA
>D> LORATADINE
>D> SYRUP; ORAL
>D> CLARITIN
>D> + SCHERING 1MG/ML N20641 001 OCT 10, 1996 MAY DISC
>A> @ 1MG/ML N20641 001 OCT 10, 1996 MAY DISC
>D> TABLET; ORAL
>D> + SCHERING 10MG N19658 001 APR 12, 1993 MAY DISC
>A> @ 10MG N19658 001 APR 12, 1993 MAY DISC
>D> TABLET, ORALLY DISINTEGRATING; ORAL
>D> CLARITIN REDITABS
>D> + SCHERING 10MG N20704 001 DEC 23, 1996 MAY DISC
>A> @ 10MG N20704 001 DEC 23, 1996 MAY DISC
LORAZEPAM
CONCENTRATE; ORAL
LORAZEPAM INTENSOL
>D> ROXANE 2MG/ML N72755 001 JUN 28, 1991 MAY CRLD
>A> + 2MG/ML N72755 001 JUN 28, 1991 MAY CRLD
MECLOFENAMATE SODIUM
CAPSULE; ORAL
MECLOFENAMATE SODIUM
>D> AB MYLAN EQ 100MG BASE N71081 001 SEP 03, 1986 MAY CRLD
>A> AB + EQ 100MG BASE N71081 001 SEP 03, 1986 MAY CRLD
>D> MECLOMEN
>D> AB PARKE DAVIS EQ 50MG BASE N18006 001 MAY DISC
>A> @ EQ 50MG BASE N18006 001 MAY DISC
>D> AB + EQ 100MG BASE N18006 002 MAY DISC
>A> @ EQ 100MG BASE N18006 002 MAY DISC
MEGESTROL ACETATE
SUSPENSION; ORAL
MEGESTROL ACETATE
>A> AB COPLEY PHARM 40MG/ML N75681 001 MAY 05, 2003 MAY NEWA
MENOTROPINS (FSH;LH)
INJECTABLE; INJECTION
REPRONEX
>D> BX FERRING 75 IU/VIAL;75 IU/VIAL N21047 001 AUG 27, 1999 MAY CRLD
>A> BX + 75 IU/VIAL;75 IU/VIAL N21047 001 AUG 27, 1999 MAY CRLD
>D> + 150 IU/VIAL;150 IU/VIAL N21047 002 AUG 27, 1999 MAY DISC
>A> @ 150 IU/VIAL;150 IU/VIAL N21047 002 AUG 27, 1999 MAY DISC
MEPERIDINE HYDROCHLORIDE
INJECTABLE; INJECTION
MEPERIDINE HCL
>A> AP BAXTER HLTHCARE CORP 25MG/ML N80455 007 MAY CAHN
>A> AP 50MG/ML N80455 008 MAY CAHN
>A> AP 75MG/ML N80455 009 MAY CAHN
>A> AP 100MG/ML N80455 010 MAY CAHN
>D> AP WYETH AYERST 25MG/ML N80455 007 MAY CAHN
>D> AP 50MG/ML N80455 008 MAY CAHN
>D> AP 75MG/ML N80455 009 MAY CAHN
>D> AP 100MG/ML N80455 010 MAY CAHN
TABLET; ORAL
>A> AA AXIOM PHARM 50MG N80448 001 MAY CAHN
>A> AA 100MG N80448 002 MAY CAHN
>D> AA HALSEY 50MG N80448 001 MAY CAHN
>D> AA 100MG N80448 002 MAY CAHN
MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
MEPERGAN
>A> @ BAXTER HLTHCARE CORP 25MG/ML;25MG/ML N11730 001 MAY CAHN
>D> @ WYETH AYERST 25MG/ML;25MG/ML N11730 001 MAY CAHN
METHYLDOPA
TABLET; ORAL
ALDOMET
>D> AB MERCK 125MG N13400 003 MAY DISC
>A> @ 125MG N13400 003 MAY DISC
>D> AB 250MG N13400 001 MAY DISC
>A> @ 250MG N13400 001 MAY DISC
METHYLPHENIDATE HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
CONCERTA
>D> + ALZA 18MG N21121 001 AUG 01, 2000 MAY CAHN
>D> + 27MG N21121 004 APR 01, 2002 MAY CAHN
>D> + 36MG N21121 002 AUG 01, 2000 MAY CAHN
>D> + 54MG N21121 003 DEC 08, 2000 MAY CAHN
>A> + MCNEIL CONS SPECLT 18MG N21121 001 AUG 01, 2000 MAY CAHN
>A> + 27MG N21121 004 APR 01, 2002 MAY CAHN
>A> + 36MG N21121 002 AUG 01, 2000 MAY CAHN
>A> + 54MG N21121 003 DEC 08, 2000 MAY CAHN
MILRINONE LACTATE
INJECTABLE; INJECTION
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
>D> AP SANOFI SYNTHELABO EQ 20MG BASE/100ML N20343 003 AUG 09, 1994 MAY CRLD
>A> AP + EQ 20MG BASE/100ML N20343 003 AUG 09, 1994 MAY CRLD
MOEXIPRIL HYDROCHLORIDE
TABLET; ORAL
>A> MOEXIPRIL HCL
>A> AB TEVA 7.5MG N76204 001 MAY 08, 2003 MAY NEWA
>A> AB 15MG N76204 002 MAY 08, 2003 MAY NEWA
UNIVASC
>D> SCHWARZ PHARMA 7.5MG N20312 001 APR 19, 1995 MAY CFTG
>A> AB 7.5MG N20312 001 APR 19, 1995 MAY CFTG
>D> + 15MG N20312 002 APR 19, 1995 MAY CFTG
>A> AB + 15MG N20312 002 APR 19, 1995 MAY CFTG
NALBUPHINE HYDROCHLORIDE
INJECTABLE; INJECTION
NALBUPHINE HCL
>D> AP KING PHARMS 10MG/ML N74471 001 MAR 19, 1998 MAY DISC
>A> @ 10MG/ML N74471 001 MAR 19, 1998 MAY DISC
>D> AP 20MG/ML N74471 002 MAR 19, 1998 MAY DISC
>A> @ 20MG/ML N74471 002 MAR 19, 1998 MAY DISC
NANDROLONE DECANOATE
INJECTABLE; INJECTION
>D> DECA-DURABOLIN
>D> AO + ORGANON 50MG/ML N13132 001 JUN 12, 1986 MAY DISC
>D> AO + 100MG/ML N13132 002 JUN 12, 1986 MAY DISC
>D> AO + 200MG/ML N13132 003 JUN 12, 1986 MAY DISC
>A> @ ORGANON USA INC 50MG/ML N13132 001 JUN 12, 1986 MAY DISC
>A> @ 100MG/ML N13132 002 JUN 12, 1986 MAY DISC
>A> @ 200MG/ML N13132 003 JUN 12, 1986 MAY DISC
NANDROLONE DECANOATE
>D> AO STERIS 50MG/ML N86385 001 JAN 13, 1984 MAY CRLD
>A> + 50MG/ML N86385 001 JAN 13, 1984 MAY CRLD
>D> AO 100MG/ML N86598 001 JAN 13, 1984 MAY CRLD
>A> + 100MG/ML N86598 001 JAN 13, 1984 MAY CRLD
>D> AO 200MG/ML N88128 001 DEC 05, 1983 MAY CRLD
>A> + 200MG/ML N88128 001 DEC 05, 1983 MAY CRLD
NITROGLYCERIN
INJECTABLE; INJECTION
>D> TRIDIL
>D> + FAULDING 0.5MG/ML N18537 002 JUN 16, 1983 MAY DISC
>A> @ 0.5MG/ML N18537 002 JUN 16, 1983 MAY DISC
>D> AP + 5MG/ML N18537 001 MAY DISC
>A> @ 5MG/ML N18537 001 MAY DISC
NORFLOXACIN
>D> SOLUTION/DROPS; OPHTHALMIC
>D> CHIBROXIN
>D> + MERCK 0.3% N19757 001 JUN 17, 1991 MAY DISC
>A> @ 0.3% N19757 001 JUN 17, 1991 MAY DISC
OLANZAPINE
TABLET; ORAL
ZYPREXA
>D> LILLY 5MG N20592 002 SEP 30, 1996 MAY CRLD
>A> + 5MG N20592 002 SEP 30, 1996 MAY CRLD
>D> + 20MG N20592 006 SEP 09, 1997 MAY CRLD
>A> 20MG N20592 006 SEP 09, 1997 MAY CRLD
OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL
OMEPRAZOLE
>A> AB MYLAN 10MG N75876 001 MAY 29, 2003 MAY NEWA
>A> AB 20MG N75876 002 MAY 29, 2003 MAY NEWA
OXYBUTYNIN CHLORIDE
TABLET, EXTENDED RELEASE; ORAL
DITROPAN XL
>D> + ALZA 5MG N20897 001 DEC 16, 1998 MAY CRLD
>A> 5MG N20897 001 DEC 16, 1998 MAY CRLD
>D> + 10MG N20897 002 DEC 16, 1998 MAY CRLD
>A> 10MG N20897 002 DEC 16, 1998 MAY CRLD
OXYTOCIN
INJECTABLE; INJECTION
OXYTOCIN
>A> @ BAXTER HLTHCARE CORP 10USP UNITS/ML N18243 001 MAY CAHN
>D> @ WYETH AYERST 10USP UNITS/ML N18243 001 MAY CAHN
PANCURONIUM BROMIDE
INJECTABLE; INJECTION
PANCURONIUM BROMIDE
>D> AP GENSIA SICOR PHARMS 1MG/ML N72759 001 JUL 31, 1990 MAY CRLD
>A> AP + 1MG/ML N72759 001 JUL 31, 1990 MAY CRLD
>D> AP 2MG/ML N72760 001 JUL 31, 1990 MAY CRLD
>A> AP + 2MG/ML N72760 001 JUL 31, 1990 MAY CRLD
PAVULON
>D> AP + ORGANON 1MG/ML N17015 002 MAY DISC
>A> @ 1MG/ML N17015 002 MAY DISC
>D> AP + 2MG/ML N17015 001 MAY DISC
>A> @ 2MG/ML N17015 001 MAY DISC
PAROMOMYCIN SULFATE
CAPSULE; ORAL
HUMATIN
>A> AA + KING PHARMS EQ 250MG BASE N62310 001 MAY CAHN
>D> AA + PARKEDALE EQ 250MG BASE N62310 001 MAY CAHN
PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL
PHENTERMINE HCL
>A> AA AMBI PHARMS 30MG N40083 001 MAR 07, 1997 MAY CAHN
>D> AA KING PHARMS 30MG N40083 001 MAR 07, 1997 MAY CAHN
PIRBUTEROL ACETATE
AEROSOL, METERED; INHALATION
MAXAIR
>D> + 3M EQ 0.2MG BASE/INH N19009 001 DEC 30, 1986 MAY DISC
>A> @ EQ 0.2MG BASE/INH N19009 001 DEC 30, 1986 MAY DISC
PREDNISOLONE
SYRUP; ORAL
PREDNISOLONE
>A> AA AXIOM PHARM 15MG/5ML N40287 001 MAY 28, 1999 MAY CAHN
>D> AA HALSEY 15MG/5ML N40287 001 MAY 28, 1999 MAY CAHN
PRELONE
>D> AA + MURO 15MG/5ML N89081 001 FEB 04, 1986 MAY CAHN
>A> AA + TEVA 15MG/5ML N89081 001 FEB 04, 1986 MAY CAHN
PROCHLORPERAZINE EDISYLATE
INJECTABLE; INJECTION
PROCHLORPERAZINE EDISYLATE
>A> AP GENSIA SICOR PHARMS EQ 5MG BASE/ML N40505 001 MAY 30, 2003 MAY NEWA
PROPIOMAZINE HYDROCHLORIDE
INJECTABLE; INJECTION
LARGON
>A> @ BAXTER HLTHCARE CORP 20MG/ML N12382 002 MAY CAHN
>D> @ WYETH AYERST 20MG/ML N12382 002 MAY CAHN
PROPRANOLOL HYDROCHLORIDE
INJECTABLE; INJECTION
INDERAL
>A> AP + BAXTER HLTHCARE CORP 1MG/ML N16419 001 MAY CAHN
>D> AP + WYETH AYERST 1MG/ML N16419 001 MAY CAHN
PYRIDOSTIGMINE BROMIDE
INJECTABLE; INJECTION
>D> REGONOL
>D> AP + ORGANON 5MG/ML N17398 001 MAY DISC
>A> @ 5MG/ML N17398 001 MAY DISC
QUINAPRIL HYDROCHLORIDE
TABLET; ORAL
ACCUPRIL
>D> PFIZER PHARMS EQ 5MG BASE N19885 001 NOV 19, 1991 MAY CFTG
>A> AB EQ 5MG BASE N19885 001 NOV 19, 1991 MAY CFTG
>D> EQ 10MG BASE N19885 002 NOV 19, 1991 MAY CFTG
>A> AB EQ 10MG BASE N19885 002 NOV 19, 1991 MAY CFTG
>D> EQ 20MG BASE N19885 003 NOV 19, 1991 MAY CFTG
>A> AB EQ 20MG BASE N19885 003 NOV 19, 1991 MAY CFTG
>D> + EQ 40MG BASE N19885 004 NOV 19, 1991 MAY CFTG
>A> AB + EQ 40MG BASE N19885 004 NOV 19, 1991 MAY CFTG
>A> QUINAPRIL HCL
>A> AB TEVA EQ 5MG BASE N75504 001 MAY 30, 2003 MAY NEWA
>A> AB EQ 10MG BASE N75504 002 MAY 30, 2003 MAY NEWA
>A> AB EQ 20MG BASE N75504 003 MAY 30, 2003 MAY NEWA
>A> AB EQ 40MG BASE N75504 004 NOV 20, 1998 MAY NEWA
QUINIDINE GLUCONATE
TABLET, EXTENDED RELEASE; ORAL
QUINIDINE GLUCONATE
>D> BX + MUTUAL PHARM 324MG N89338 001 FEB 11, 1987 MAY CTEC
>A> + 324MG N89338 001 FEB 11, 1987 MAY CTEC
>D> BX WATSON LABS 324MG N87810 001 SEP 29, 1982 MAY DISC
>A> @ 324MG N87810 001 SEP 29, 1982 MAY DISC
>D> RESERPINE; TRICHLORMETHIAZIDE
>D> TABLET; ORAL
>D> METATENSIN #2
>D> AVENTIS PHARMS 0.1MG;2MG N12972 001 MAY DISC
>A> @ 0.1MG;2MG N12972 001 MAY DISC
>D> METATENSIN #4
>D> + AVENTIS PHARMS 0.1MG;4MG N12972 002 MAY DISC
>A> @ 0.1MG;4MG N12972 002 MAY DISC
SACROSIDASE
SOLUTION; ORAL
SUCRAID
>D> + ORPHAN MEDCL 8,500 IU/ML N20772 001 APR 09, 1998 MAY CAHN
>A> + QOL MEDCL 8,500 IU/ML N20772 001 APR 09, 1998 MAY CAHN
SOTALOL HYDROCHLORIDE
TABLET; ORAL
>D> BETAPACE AF
>D> BERLEX LABS 40MG N21151 006 APR 02, 2003 MAY DISC
>A> @ 40MG N21151 006 APR 02, 2003 MAY DISC
>D> 60MG N21151 007 APR 02, 2003 MAY DISC
>A> @ 60MG N21151 007 APR 02, 2003 MAY DISC
>D> 100MG N21151 005 MAR 14, 2003 MAY DISC
>A> @ 100MG N21151 005 MAR 14, 2003 MAY DISC
SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE; INJECTION
SEPTRA
>D> AP + MONARCH PHARMS 80MG/ML;16MG/ML N18452 001 MAY DISC
>A> @ 80MG/ML;16MG/ML N18452 001 MAY DISC
>D> TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT
>D> INJECTABLE; INJECTION
>D> PYROLITE
>D> CIS N/A N17684 001 MAY DISC
>A> @ N/A N17684 001 MAY DISC
TETRACYCLINE HYDROCHLORIDE
CAPSULE; ORAL
TETRACYCLINE HCL
>A> AB AXIOM PHARM 250MG N60736 001 MAY CAHN
>A> AB 500MG N60736 002 MAY CAHN
>D> AB HALSEY 250MG N60736 001 MAY CAHN
>D> AB 500MG N60736 002 MAY CAHN
TORSEMIDE
TABLET; ORAL
TORSEMIDE
>A> AB PAR PHARM 5MG N76226 001 MAY 27, 2003 MAY NEWA
>A> AB 10MG N76226 002 MAY 27, 2003 MAY NEWA
>A> AB 20MG N76226 003 MAY 27, 2003 MAY NEWA
>A> AB 100MG N76226 004 MAY 27, 2003 MAY NEWA
>A> AB PLIVA PHARM IND 5MG N76346 001 MAY 30, 2003 MAY NEWA
>A> AB 10MG N76346 002 MAY 30, 2003 MAY NEWA
>A> AB 20MG N76346 003 MAY 30, 2003 MAY NEWA
TRICHLORMETHIAZIDE
TABLET; ORAL
>D> METAHYDRIN
>D> BP AVENTIS PHARMS 2MG N12594 001 JUN 16, 1988 MAY DISC
>A> @ 2MG N12594 001 JUN 16, 1988 MAY DISC
>D> BP 4MG N12594 002 JUN 16, 1988 MAY DISC
>A> @ 4MG N12594 002 JUN 16, 1988 MAY DISC
TRIMETHOPRIM
TABLET; ORAL
PROLOPRIM
>D> AB + MONARCH PHARMS 200MG N17943 003 JUL 14, 1982 MAY DISC
>A> @ 200MG N17943 003 JUL 14, 1982 MAY DISC
TRIMETHOPRIM
>D> AB TEVA 200MG N71259 001 JUN 18, 1987 MAY CRLD
>A> + 200MG N71259 001 JUN 18, 1987 MAY CRLD
UREA, C-13
FOR SOLUTION; ORAL
>D> HELICOSOL
>D> + METABOLIC SOLUTIONS 125MG/VIAL N21092 001 DEC 17, 1999 MAY DISC
>A> @ 125MG/VIAL N21092 001 DEC 17, 1999 MAY DISC
VECURONIUM BROMIDE
INJECTABLE; INJECTION
>D> NORCURON
>D> AP + ORGANON 10MG/VIAL N18776 002 APR 30, 1984 MAY DISC
>A> @ 10MG/VIAL N18776 002 APR 30, 1984 MAY DISC
VECURONIUM BROMIDE
>D> AP BEDFORD 10MG/VIAL N75549 001 JUN 13, 2000 MAY CRLD
>A> AP + 10MG/VIAL N75549 001 JUN 13, 2000 MAY CRLD
>D> VIDARABINE
>D> OINTMENT; OPHTHALMIC
>D> VIRA-A
>D> + PARKEDALE 3% N50486 001 MAY DISC
>A> @ 3% N50486 001 MAY DISC
EPINEPHRINE
AEROSOL, METERED; INHALATION
>D> BRONKAID MIST
>D> + STERLING 0.25MG/INH N16803 001 MAY DISC
>A> @ 0.25MG/INH N16803 001 MAY DISC
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FDA/Center for Drug Evaluation and Research
Last Updated: June 27, 2003
Originator: OIT/DDMS
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