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
Back to Top Product List Archive
FDA/Center for Drug Evaluation and Research
Last Updated: March 18, 2003
Originator: OIT/DDMS
HTML by PKS