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; CODEINE PHOSPHATE
TABLET; ORAL
>A> CODRIX
>A> + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA
AZATHIOPRINE
TABLET; ORAL
AZASAN
>A> AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA
>A> AB 50MG N75252 001 JUN 07, 1999 FEB NEWA
>A> 75MG N75252 003 FEB 03, 2003 FEB NEWA
>A> 100MG N75252 004 FEB 03, 2003 FEB NEWA
CALCITRIOL
INJECTABLE; INJECTION
CALCITRIOL
>A> AP AAIPHARMA 0.001MG/ML N75766 001 FEB 20, 2003 FEB NEWA
>A> AP 0.002MG/ML N75766 002 FEB 20, 2003 FEB NEWA
CICLOPIROX
>A> SHAMPOO; TOPICAL
>A> LOPROX
>A> + MEDICIS 1% N21159 001 FEB 28, 2003 FEB NEWA
CYCLOSPORINE
CAPSULE; ORAL
GENGRAF
>D> AB1 ABBOTT 25MG N65003 001 MAY 12, 2000 FEB CTNA
>A> AB1 25MG N65003 001 MAY 12, 2000 FEB CTNA
>D> BX 50MG N65003 002 MAY 12, 2000 FEB CTNA
>A> BX 50MG N65003 002 MAY 12, 2000 FEB CTNA
>D> AB1 100MG N65003 003 MAY 12, 2000 FEB CTNA
>A> AB1 100MG N65003 003 MAY 12, 2000 FEB CTNA
DALFOPRISTIN; QUINUPRISTIN
INJECTABLE; IV (INFUSION)
SYNERCID
>D> + AVENTIS 350MG/VIAL;150MG/VIAL N50748 001 SEP 21, 1999 FEB CAHN
>D> @ 420MG/VIAL;180MG/VIAL N50748 002 AUG 24, 2000 FEB CAHN
>A> + KING PHARMS 350MG/VIAL;150MG/VIAL N50748 001 SEP 21, 1999 FEB CAHN
>A> @ 420MG/VIAL;180MG/VIAL N50748 002 AUG 24, 2000 FEB CAHN
DILTIAZEM HYDROCHLORIDE
TABLET, EXTENDED RELEASE; ORAL
>A> CARDIZEM LA
>A> + BIOVAIL 120MG N21392 001 FEB 06, 2003 FEB NEWA
>A> + 180MG N21392 002 FEB 06, 2003 FEB NEWA
>A> + 240MG N21392 003 FEB 06, 2003 FEB NEWA
>A> + 300MG N21392 004 FEB 06, 2003 FEB NEWA
>A> + 360MG N21392 005 FEB 06, 2003 FEB NEWA
>A> + 420MG N21392 006 FEB 06, 2003 FEB NEWA
DOXYCYCLINE HYCLATE
CAPSULE, COATED PELLETS; ORAL
DORYX
>A> FAULDING EQ 75MG BASE N50582 002 AUG 13, 2001 FEB NEWA
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET; ORAL-21
>D> TRI-NORINYL 21-DAY
>D> + WATSON LABS 0.035MG,0.035MG;0.5MG,1MG N18977 001 APR 13, 1984 FEB DISC
>A> @ 0.035MG,0.035MG;0.5MG,1MG N18977 001 APR 13, 1984 FEB DISC
TABLET; ORAL-28
ORTHO-NOVUM 7/7/7-28
>D> AB ORTHO MCNEIL PHARM 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0
.75MG N18985 002 APR 04, 1984 FEB CRLD
>A> AB + 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0
.75MG N18985 002 APR 04, 1984 FEB CRLD
ETHINYL ESTRADIOL; NORGESTREL
TABLET; ORAL-21
OGESTREL 0.5/50-21
>D> AB SCS 0.05MG;0.5MG N75406 001 DEC 15, 1999 FEB CAHN
>A> AB WATSON LABS 0.05MG;0.5MG N75406 001 DEC 15, 1999 FEB CAHN
TABLET; ORAL-28
OGESTREL 0.5/50-28
>D> AB SCS 0.05MG;0.5MG N75406 002 DEC 15, 1999 FEB CAHN
>A> AB WATSON LABS 0.05MG;0.5MG N75406 002 DEC 15, 1999 FEB CAHN
GENTAMICIN SULFATE
CREAM; TOPICAL
>D> GARAMYCIN
>D> AT + SCHERING EQ 0.1% BASE N60462 001 FEB DISC
>A> @ EQ 0.1% BASE N60462 001 FEB DISC
GENTAMICIN SULFATE
>D> AT FOUGERA EQ 0.1% BASE N62531 001 JUL 05, 1984 FEB CRLD
>A> AT + EQ 0.1% BASE N62531 001 JUL 05, 1984 FEB CRLD
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION/DROPS; OTIC
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
>D> @ ALCON 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N62423 001 AUG 25, 1983 FEB CMFD
>A> AT 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N62423 001 AUG 25, 1983 FEB CMFD
SUSPENSION/DROPS; OPHTHALMIC
>D> @ ALCON UNIVERSAL 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N62874 001 MAY 11, 1988 FEB CMFD
>A> AT 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N62874 001 MAY 11, 1988 FEB CMFD
SUSPENSION/DROPS; OTIC
>D> @ ALCON UNIVERSAL 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N62488 001 NOV 06, 1985 FEB CMFD
>A> AT 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N62488 001 NOV 06, 1985 FEB CMFD
HYDROXYZINE HYDROCHLORIDE
TABLET; ORAL
>D> ATARAX
>A> @ PFIZER 10MG N10392 001 FEB DISC
>A> @ 25MG N10392 004 FEB DISC
>A> @ 50MG N10392 006 FEB DISC
>A> @ 100MG N10392 005 FEB DISC
>D> AB + ROERIG 10MG N10392 001 FEB DISC
>D> AB + 25MG N10392 004 FEB DISC
>D> AB + 50MG N10392 006 FEB DISC
>D> AB + 100MG N10392 005 FEB DISC
HYDROXYZINE HCL
>D> AB SIDMAK LABS NJ 10MG N88617 001 JAN 10, 1986 FEB CRLD
>A> AB + 10MG N88617 001 JAN 10, 1986 FEB CRLD
>D> AB 25MG N88618 001 JAN 10, 1986 FEB CRLD
>A> AB + 25MG N88618 001 JAN 10, 1986 FEB CRLD
>D> AB 50MG N88619 001 JAN 10, 1986 FEB CRLD
>A> AB + 50MG N88619 001 JAN 10, 1986 FEB CRLD
>D> AB 100MG N81054 001 SEP 25, 1995 FEB DISC
>A> @ 100MG N81054 001 SEP 25, 1995 FEB DISC
LEUPROLIDE ACETATE
INJECTABLE; SUBCUTANEOUS
>A> ELIGARD
>A> + ATRIX 30MG/VIAL N21488 001 FEB 13, 2003 FEB NEWA
LEVORPHANOL TARTRATE
TABLET; ORAL
>D> LEVO-DROMORAN
>D> AB + ICN 2MG N08720 001 DEC 19, 1991 FEB DISC
>A> @ 2MG N08720 001 DEC 19, 1991 FEB DISC
LEVORPHANOL TARTRATE
>D> AB ROXANE 2MG N74278 001 MAR 31, 2000 FEB CRLD
>A> + 2MG N74278 001 MAR 31, 2000 FEB CRLD
LIDOCAINE HYDROCHLORIDE
JELLY; TOPICAL
LIDOCAINE HCL
>A> AT AKORN 2% N40433 001 FEB 12, 2003 FEB NEWA
LISINOPRIL
TABLET; ORAL
LISINOPRIL
>A> AB RANBAXY 30MG N75944 006 FEB 11, 2003 FEB NEWA
LITHIUM CARBONATE
CAPSULE; ORAL
LITHIUM CARBONATE
>D> ROXANE 150MG N17812 002 JAN 28, 1987 FEB CTEC
>A> AB 150MG N17812 002 JAN 28, 1987 FEB CTEC
>A> AB WEST WARD 150MG N76243 002 FEB 24, 2003 FEB NEWA
LORAZEPAM
INJECTABLE; INJECTION
ATIVAN
>A> AP + BAXTER HLTHCARE CORP 2MG/ML N18140 001 FEB CAHN
>A> AP + 4MG/ML N18140 002 FEB CAHN
>D> AP + WYETH AYERST 2MG/ML N18140 001 FEB CAHN
>D> AP + 4MG/ML N18140 002 FEB CAHN
MEPHENTERMINE SULFATE
INJECTABLE; INJECTION
WYAMINE SULFATE
>A> @ BAXTER HLTHCARE CORP EQ 15MG BASE/ML N08248 002 FEB CAHN
>A> @ EQ 30MG BASE/ML N08248 001 FEB CAHN
>D> @ WYETH AYERST EQ 15MG BASE/ML N08248 002 FEB CAHN
>D> @ EQ 30MG BASE/ML N08248 001 FEB CAHN
METFORMIN HYDROCHLORIDE
TABLET; ORAL
METFORMIN HCL
>D> AB PUREPAC PHARM 1GM N76033 003 JAN 24, 2002 FEB CMS1
>A> AB 1GM N76033 003 JAN 24, 2002 FEB CMS1
METHADONE HYDROCHLORIDE
INJECTABLE; INJECTION
DOLOPHINE HCL
>D> + ROXANE 10MG/ML N06134 006 FEB DISC
>A> @ 10MG/ML N06134 006 FEB DISC
>A> + 10MG/ML N21624 001 FEB CMS1
>D> 10MG/ML N21624 001 FEB CMS1
MYCOPHENOLATE MOFETIL
CAPSULE; ORAL
CELLCEPT
>D> + ROCHE GLOBAL DEV 250MG N50722 001 MAY 03, 1995 FEB CAHN
>A> + ROCHE PALO 250MG N50722 001 MAY 03, 1995 FEB CAHN
SUSPENSION; ORAL
>D> + ROCHE GLOBAL DEV 200MG/ML N50759 001 OCT 01, 1998 FEB CAHN
>A> + ROCHE PALO 200MG/ML N50759 001 OCT 01, 1998 FEB CAHN
TABLET; ORAL
>D> + ROCHE GLOBAL DEV 500MG N50723 001 JUN 19, 1997 FEB CAHN
>A> + ROCHE PALO 500MG N50723 001 JUN 19, 1997 FEB CAHN
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
INJECTABLE; INJECTION
>D> + ROCHE GLOBAL DEV 500MG/VIAL N50758 001 AUG 12, 1998 FEB CAHN
>A> + ROCHE PALO 500MG/VIAL N50758 001 AUG 12, 1998 FEB CAHN
>A> OXYBUTYNIN
>A> FILM, EXTENDED RELEASE; TRANSDERMAL
>A> OXYTROL
>A> + WATSON LABS (UTAH) 3.9MG/24HR N21351 002 FEB 26, 2003 FEB NEWA
PERPHENAZINE
TABLET; ORAL
PERPHENAZINE
>D> AB IVAX PHARMS 16MG N89457 001 SEP 10, 1987 FEB CRLD
>A> AB + 16MG N89457 001 SEP 10, 1987 FEB CRLD
>D> TRILAFON
>D> AB SCHERING 2MG N10775 001 FEB DISC
>A> @ 2MG N10775 001 FEB DISC
>D> AB 4MG N10775 002 FEB DISC
>A> @ 4MG N10775 002 FEB DISC
>D> AB 8MG N10775 003 FEB DISC
>A> @ 8MG N10775 003 FEB DISC
>D> AB + 16MG N10775 004 FEB DISC
>A> @ 16MG N10775 004 FEB DISC
PHENYTOIN SODIUM, EXTENDED
CAPSULE; ORAL
DILANTIN
>D> + PARKE DAVIS 30MG N84349 001 FEB CRLD
>A> 30MG N84349 001 FEB CRLD
PREDNISOLONE
SYRUP; ORAL
PREDNISOLONE
>A> AA HI TECH PHARMA 15MG/5ML N40401 001 FEB 27, 2003 FEB NEWA
PREDNISONE
TABLET; ORAL
PREDNISONE
>A> AB VINTAGE PHARMS 20MG N40392 001 FEB 12, 2003 FEB NEWA
PROMETHAZINE HYDROCHLORIDE
SUPPOSITORY; RECTAL
PHENERGAN
>D> BR + WYETH AYERST 50MG N11689 001 FEB CTEC
>A> AB + 50MG N11689 001 FEB CTEC
PROMETHAZINE HCL
>A> AB ABLE 50MG N40449 001 FEB 27, 2003 FEB NEWA
PROPRANOLOL HYDROCHLORIDE
INJECTABLE; INJECTION
PROPRANOLOL HCL
>A> AP SABEX 2002 1MG/ML N76400 001 FEB 26, 2003 FEB NEWA
PYRIDOSTIGMINE BROMIDE
TABLET; ORAL
>D> PYRIDOSTIGMINE BROMIDE
>A> @ US ARMY 30MG N20414 001 FEB 05, 2003 FEB DISC
>D> 30MG N20414 001 FEB 05, 2003 FEB DISC
SODIUM IODIDE, I-131
SOLUTION; ORAL
SODIUM IODIDE I 131, KIT
>D> + DRAXIMAGE 1-250mCi/0.25ML N21305 002 JAN 24, 2003 FEB CDFR
>D> + 1-500mCi/0.5ML N21305 003 JAN 24, 2003 FEB CDFR
>A> + 1-250mCi/0.25ML N21305 002 JAN 24, 2003 FEB CDFR
>A> + 1-500mCi/0.5ML N21305 003 JAN 24, 2003 FEB CDFR
SOMATROPIN RECOMBINANT
INJECTABLE; INJECTION
TEV-TROPIN
>D> BX + BIO TECH GEN 5MG/ML N19774 002 JAN 04, 2002 FEB CTNA
>A> BX + 5MG/ML N19774 002 JAN 04, 2002 FEB CTNA
TAMOXIFEN CITRATE
TABLET; ORAL
NOLVADEX
>D> ASTRAZENECA EQ 10MG BASE N17970 001 FEB CTEC
>A> AB EQ 10MG BASE N17970 001 FEB CTEC
>D> + EQ 20MG BASE N17970 002 MAR 21, 1994 FEB CTEC
>A> AB + EQ 20MG BASE N17970 002 MAR 21, 1994 FEB CTEC
>A> TAMOXIFEN CITRATE
>A> AB ANDRX PHARMS EQ 10MG BASE N76179 001 FEB 20, 2003 FEB NEWA
>A> AB EQ 20MG BASE N76179 002 FEB 20, 2003 FEB NEWA
>A> AB BARR EQ 10MG BASE N70929 001 FEB 20, 2003 FEB NEWA
>A> AB EQ 20MG BASE N70929 002 FEB 20, 2003 FEB NEWA
>A> AB IVAX PHARMS EQ 10MG BASE N75740 001 FEB 20, 2003 FEB NEWA
>A> AB EQ 20MG BASE N75740 002 FEB 20, 2003 FEB NEWA
>A> AB MYLAN EQ 10MG BASE N74732 002 FEB 20, 2003 FEB NEWA
>A> AB EQ 20MG BASE N74732 001 FEB 20, 2003 FEB NEWA
>A> AB PHARMACHEMIE EQ 20MG BASE N74858 001 FEB 20, 2003 FEB NEWA
>A> AB ROXANE EQ 10MG BASE N76027 001 FEB 20, 2003 FEB NEWA
>A> AB EQ 20MG BASE N76027 002 FEB 20, 2003 FEB NEWA
>A> AB TEVA EQ 10MG BASE N75797 001 FEB 20, 2003 FEB NEWA
THIOTHIXENE
CAPSULE; ORAL
NAVANE
>A> AB PFIZER 1MG N16584 001 FEB CAHN
>A> AB 2MG N16584 002 FEB CAHN
>A> AB + 5MG N16584 003 FEB CAHN
>A> AB 10MG N16584 004 FEB CAHN
>A> 20MG N16584 005 FEB CAHN
>D> AB ROERIG 1MG N16584 001 FEB CAHN
>D> AB 2MG N16584 002 FEB CAHN
>D> AB + 5MG N16584 003 FEB CAHN
>D> AB 10MG N16584 004 FEB CAHN
>D> 20MG N16584 005 FEB CAHN
THIOTHIXENE HYDROCHLORIDE
CONCENTRATE; ORAL
>A> AA + PFIZER EQ 5MG BASE/ML N16758 001 FEB CAHN
>D> AA + ROERIG EQ 5MG BASE/ML N16758 001 FEB CAHN
INJECTABLE; INJECTION
>A> @ PFIZER EQ 2MG BASE/ML N16904 001 FEB CAHN
>A> + EQ 10MG BASE/VIAL N16904 002 FEB CAHN
>D> @ ROERIG EQ 2MG BASE/ML N16904 001 FEB CAHN
>D> + EQ 10MG BASE/VIAL N16904 002 FEB CAHN
VINORELBINE TARTRATE
INJECTABLE; INJECTION
NAVELBINE
>D> + GLAXOSMITHKLINE EQ 10MG BASE/ML N20388 001 DEC 23, 1994 FEB CFTG
>A> AP + EQ 10MG BASE/ML N20388 001 DEC 23, 1994 FEB CFTG
>A> VINORELBINE TARTRATE
>A> AP GENSIA SICOR PHARMS EQ 10MG BASE/ML N76028 001 FEB 03, 2003 FEB NEWA
LORATADINE
TABLET, ORALLY DISINTEGRATING; ORAL
LORATADINE
>A> WYETH CONS 10MG N75822 001 FEB 10, 2003 FEB NEWA
LORATADINE; PSEUDOEPHEDRINE SULFATE
>A> TABLET, EXTENDED RELEASE; ORAL
>A> LORATADINE AND PSEUDOEPHEDRINE HCL
>A> + ANDRX PHARMS 10MG;240MG N75706 001 FEB 21, 2003 FEB NEWA
MINOXIDIL
SOLUTION; TOPICAL
MINOXIDIL EXTRA STRENGTH (FOR MEN)
>A> MORTON GROVE 5% N75438 001 FEB 27, 2003 FEB 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