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
>A> SOLUTION; ORAL
>A> ACETAMINOPHEN AND BUTALBITAL AND CAFFEINE
>A> + MIKART 325MG/15ML;50MG/15ML;40MG/15ML N40387 001 JAN 31, 2003 JAN NEWA
ACETAMINOPHEN; CODEINE PHOSPHATE
TABLET; ORAL
ACETAMINOPHEN AND CODEINE PHOSPAHTE
>A> AA ANDRX PHARMS 300MG;15MG N40443 001 JAN 22, 2003 JAN NEWA
>A> AA 300MG;30MG N40443 002 JAN 22, 2003 JAN NEWA
>A> AA 300MG;60MG N40443 003 JAN 22, 2003 JAN NEWA
ACETAMINOPHEN AND CODEINE PHOSPHATE
>D> AA IVAX PHARMS 300MG;60MG N87083 001 JAN CAHN
>A> AA RANBAXY 300MG;60MG N87083 001 JAN CAHN
ACETAMINOPHEN W/ CODEINE PHOSPHATE #3
>D> AA IVAX PHARMS 300MG;30MG N85868 001 JAN CAHN
>A> AA RANBAXY 300MG;30MG N85868 001 JAN CAHN
ACETAMINOPHEN; HYDROCODONE BITARTRATE
TABLET; ORAL
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
>A> AA ABLE 650MG;7.5MG N40474 001 JAN 02, 2003 JAN NEWA
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
>A> AA MIKART 325MG;7.5MG N40432 001 JAN 22, 2003 JAN NEWA
ALPRAZOLAM
>A> TABLET, EXTENDED RELEASE; ORAL
>A> XANAX XR
>A> PHARMACIA AND UPJOHN 0.5MG N21434 001 JAN 17, 2003 JAN NEWA
>A> 1MG N21434 002 JAN 17, 2003 JAN NEWA
>A> 2MG N21434 003 JAN 17, 2003 JAN NEWA
>A> + 3MG N21434 004 JAN 17, 2003 JAN NEWA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;
DEXTROAMPHETAMINE SULFATE
CAPSULE, EXTENDED RELEASE; ORAL
ADDERALL XR 10
>A> SHIRE LABS 2.5MG;2.5MG;2.5MG;2.5MG N21303 001 OCT 11, 2001 JAN CAHN
>D> SHIRE PHARM 2.5MG;2.5MG;2.5MG;2.5MG N21303 001 OCT 11, 2001 JAN CAHN
ADDERALL XR 15
>A> SHIRE LABS 3.75MG;3.75MG;3.75MG;3.75MG N21303 006 MAY 22, 2002 JAN CAHN
>D> SHIRE PHARM 3.75MG;3.75MG;3.75MG;3.75MG N21303 006 MAY 22, 2002 JAN CAHN
ADDERALL XR 20
>A> SHIRE LABS 5MG;5MG;5MG;5MG N21303 002 OCT 11, 2001 JAN CAHN
>D> SHIRE PHARM 5MG;5MG;5MG;5MG N21303 002 OCT 11, 2001 JAN CAHN
ADDERALL XR 25
>A> SHIRE LABS 6.25MG;6.25MG;6.25MG;6.25MG N21303 004 MAY 22, 2002 JAN CAHN
>D> SHIRE PHARM 6.25MG;6.25MG;6.25MG;6.25MG N21303 004 MAY 22, 2002 JAN CAHN
ADDERALL XR 30
>A> + SHIRE LABS 7.5MG;7.5MG;7.5MG;7.5MG N21303 003 OCT 11, 2001 JAN CAHN
>D> + SHIRE PHARM 7.5MG;7.5MG;7.5MG;7.5MG N21303 003 OCT 11, 2001 JAN CAHN
ADDERALL XR 5
>A> SHIRE LABS 1.25MG;1.25MG;1.25MG;1.25MG N21303 005 MAY 22, 2002 JAN CAHN
>D> SHIRE PHARM 1.25MG;1.25MG;1.25MG;1.25MG N21303 005 MAY 22, 2002 JAN CAHN
BUSPIRONE HYDROCHLORIDE
TABLET; ORAL
BUSPIRONE HCL
>A> AB EGIS 15MG N75119 003 JAN 23, 2003 JAN NEWA
DIGOXIN
TABLET; ORAL
DIGOXIN
>A> AB CARACO 0.125MG N76363 001 JAN 31, 2003 JAN NEWA
>A> AB 0.25MG N76363 002 JAN 31, 2003 JAN NEWA
DOXAPRAM HYDROCHLORIDE
INJECTABLE; INJECTION
DOPRAM
>A> AP + BAXTER HLTHCARE CORP 20MG/ML N14879 001 JAN CAHN
>D> AP + ROBINS AH 20MG/ML N14879 001 JAN CAHN
DOXAPRAM HCL
>A> AP BEDFORD 20MG/ML N76266 001 JAN 10, 2003 JAN NEWA
ENOXAPARIN SODIUM
INJECTABLE; SUBCUTANEOUS
LOVENOX
>A> + AVENTIS 300MG/3ML N20164 009 JAN 23, 2003 JAN NEWA
ESTROGENS, ESTERIFIED
TABLET; ORAL
MENEST
>D> + MONARCH PHARMS 0.3MG N84951 001 JAN CRLD
>A> 0.3MG N84951 001 JAN CRLD
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET; ORAL-28
OVCON-35
>D> WARNER CHILCOTT 0.035MG;0.4MG N17716 001 JAN CRLD
>A> + 0.035MG;0.4MG N17716 001 JAN CRLD
OVCON-50
>D> WARNER CHILCOTT 0.05MG;1MG N17576 001 JAN CRLD
>A> + 0.05MG;1MG N17576 001 JAN CRLD
TRI-NORINYL 28-DAY
>D> WATSON LABS 0.035MG,0.035MG;0.5MG,1MG N18977 002 APR 13, 1984 JAN CRLD
>A> + 0.035MG,0.035MG;0.5MG,1MG N18977 002 APR 13, 1984 JAN CRLD
ETIDRONATE DISODIUM
TABLET; ORAL
ETIDRONATE DISODIUM
>A> AB GENPHARM 200MG N75800 001 JAN 24, 2003 JAN NEWA
>A> AB 400MG N75800 002 JAN 24, 2003 JAN NEWA
FLECAINIDE ACETATE
TABLET; ORAL
FLECAINIDE ACETATE
>A> AB ROXANE 50MG N76278 001 JAN 14, 2003 JAN NEWA
>A> AB 100MG N76278 002 JAN 14, 2003 JAN NEWA
>A> AB 150MG N76278 003 JAN 14, 2003 JAN NEWA
FLUDROCORTISONE ACETATE
TABLET; ORAL
FLUDROCORTISONE ACETATE
>A> AB BARR 0.1MG N40425 001 JAN 21, 2003 JAN NEWA
>D> FLUORESCEIN SODIUM
>D> INJECTABLE; INJECTION
>D> FUNDUSCEIN-25
>D> + NOVARTIS 25% N17869 001 JAN DISC
>A> @ 25% N17869 001 JAN DISC
GLIMEPIRIDE
TABLET; ORAL
AMARYL
>D> AVENTIS PHARMS 1MG N20496 001 NOV 30, 1995 JAN CRLD
>A> + 1MG N20496 001 NOV 30, 1995 JAN CRLD
>D> + 4MG N20496 003 NOV 30, 1995 JAN CRLD
>A> 4MG N20496 003 NOV 30, 1995 JAN CRLD
METHOCARBAMOL
TABLET; ORAL
>A> METHOCARBAMOL
>A> AA VINTAGE PHARMS 500MG N40489 001 JAN 29, 2003 JAN NEWA
>A> AA 750MG N40489 002 JAN 29, 2003 JAN NEWA
MIRTAZAPINE
TABLET; ORAL
>A> MIRTAZAPINE
>A> AB TEVA 15MG N76119 001 JAN 24, 2003 JAN NEWA
>A> AB 30MG N76119 002 JAN 24, 2003 JAN NEWA
REMERON
>D> + ORGANON 15MG N20415 001 JUN 14, 1996 JAN CFTG
>A> AB + 15MG N20415 001 JUN 14, 1996 JAN CFTG
>D> 30MG N20415 002 JUN 14, 1996 JAN CFTG
>A> AB 30MG N20415 002 JUN 14, 1996 JAN CFTG
MUPIROCIN
OINTMENT; TOPICAL
MUPIROCIN
>D> CLAY PARK LABS 2% N50788 001 DEC 04, 2002 JAN CRLD
>A> BX 2% N50788 001 DEC 04, 2002 JAN CRLD
NABUMETONE
TABLET; ORAL
NABUMETONE
>A> AB IVAX PHARMS 500MG N76009 001 JAN 24, 2003 JAN NEWA
>A> AB 750MG N76009 002 JAN 24, 2003 JAN NEWA
NIZATIDINE
CAPSULE; ORAL
NIZATIDINE
>A> AB TORPHARM 150MG N76383 001 JAN 23, 2003 JAN NEWA
>A> AB 300MG N76383 002 JAN 23, 2003 JAN NEWA
OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS; ORAL
OMEPRAZOLE
>A> AB LEK SVCS 10MG N75757 001 JAN 28, 2003 JAN NEWA
>A> AB 20MG N75757 002 JAN 28, 2003 JAN NEWA
PHENTERMINE HYDROCHLORIDE
CAPSULE; ORAL
PHENTERMINE HCL
>A> AA AMIDE PHARM 15MG N40460 001 JAN 14, 2003 JAN NEWA
>A> AA 30MG N40448 001 JAN 22, 2003 JAN NEWA
RILUZOLE
TABLET; ORAL
RILUTEK
>D> + AVENTIS 50MG N20599 001 DEC 12, 1995 JAN CFTG
>A> AB + 50MG N20599 001 DEC 12, 1995 JAN CFTG
>A> RILUZOLE
>A> AB IMPAX LABS 50MG N76173 001 JAN 29, 2003 JAN NEWA
RIMANTADINE HYDROCHLORIDE
TABLET; ORAL
RIMANTADINE HCL
>A> AB AMIDE PHARM 100MG N76375 001 JAN 14, 2003 JAN NEWA
SODIUM IODIDE, I-131
CAPSULE; ORAL
SODIUM IODIDE I 131
>A> + DRAXIMAGE 1-250mCi N21305 002 JAN 24, 2003 JAN NEWA
>A> + 1-500mCi N21305 003 JAN 24, 2003 JAN NEWA
SOLUTION; ORAL
>A> + DRAXIMAGE 1,000mCi/ML N21305 001 JAN 24, 2003 JAN NEWA
STRONTIUM CHLORIDE, SR-89
INJECTABLE; INJECTION
METASTRON
>D> + AMERSHAM HLTH 1mCi/ML N20134 001 JUN 18, 1993 JAN CFTG
>A> AP + 1mCi/ML N20134 001 JUN 18, 1993 JAN CFTG
>A> STRONTIUM CHLORIDE SR-89
>A> AP BIO NUCLEONICS 1mCi/ML N75941 001 JAN 06, 2003 JAN NEWA
THALIDOMIDE
CAPSULE; ORAL
THALOMID
>A> CELGENE 100MG N20785 002 JAN 17, 2003 JAN NEWA
>A> + 200MG N20785 003 JAN 17, 2003 JAN NEWA
GUAIFENESIN
TABLET, EXTENDED RELEASE; ORAL
MUCINEX
>D> + ADAMS LABS 600MG N21282 001 JUL 12, 2002 JAN CRLD
>A> 600MG N21282 001 JUL 12, 2002 JAN CRLD
>A> + 1.2GM N21282 002 DEC 18, 2002 JAN NEWA
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
TABLET; ORAL
IMODIUM ADVANCED
>D> MCNEIL CONS SPECLT 2MG;125MG N21140 001 NOV 30, 2000 JAN CRLD
>A> + 2MG;125MG N21140 001 NOV 30, 2000 JAN CRLD
LORATADINE
TABLET; ORAL
LORATADINE
>A> GENEVA PHARMS 10MG N75209 001 JAN 21, 2003 JAN NEWA
LORATADINE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE; ORAL
LORATADINE AND PSEUDOEPHEDRINE SULFATE
>A> IMPAX LABS 5MG;120MG N76050 001 JAN 30, 2003 JAN NEWA
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Product List Archive
FDA/Center for Drug Evaluation and Research
Last Updated: March 18, 2003
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