[Skip navigation]FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 

 Prescription and Over-the-Counter Drug Product List 
23rd Edition
Cumulative Supplement Number 10: October 2003


[Prescription - OTC]

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.



ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST


        ACETAMINOPHEN; HYDROCODONE BITARTRATE
          SOLUTION; ORAL
            HYDROCODONE BITARTRATE AND ACETAMINOPHEN
>A>   AA      VINTAGE PHARMS          500MG/15ML;7.5MG/15ML                    N40520 001  OCT 30, 2003  OCT  NEWA
          TABLET; ORAL
            ANEXSIA
>D>   AA      MALLINCKRODT            750MG;10MG                               N40468 001  OCT 31, 2002  OCT  CTNA
>A>   AA                              750MG;10MG                               N40468 001  OCT 31, 2002  OCT  CTNA

        ALBUTEROL SULFATE
          TABLET, EXTENDED RELEASE; ORAL
>D>         PROVENTIL
>D>   BC      SCHERING                EQ 4MG BASE                              N19383 001  JUL 13, 1987  OCT  DISC
>A>         @                         EQ 4MG BASE                              N19383 001  JUL 13, 1987  OCT  DISC

        ALPROSTADIL
          INJECTABLE; INJECTION
            CAVERJECT
>D>           PHARMACIA AND UPJOHN    0.01MG/ML                                N20755 002  OCT 01, 1997  OCT  DISC
>A>         @                         0.01MG/ML                                N20755 002  OCT 01, 1997  OCT  DISC
>D>   AP                              0.02MG/VIAL                              N20379 002  JUL 06, 1995  OCT  CRLD
>A>   AP  +                           0.02MG/VIAL                              N20379 002  JUL 06, 1995  OCT  CRLD
>D>       +                           0.02MG/ML                                N20755 003  OCT 01, 1997  OCT  DISC
>A>         @                         0.02MG/ML                                N20755 003  OCT 01, 1997  OCT  DISC

>A>     AMLODIPINE MALEATE
>A>       TABLET; ORAL
>A>         AMVAZ
>A>           DR REDDYS LABS INC      2.5MG                                    N21435 001  OCT 31, 2003  OCT  NEWA
>A>                                   5MG                                      N21435 002  OCT 31, 2003  OCT  NEWA
>A>       +                           10MG                                     N21435 003  OCT 31, 2003  OCT  NEWA

        AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;
        DEXTROAMPHETAMINE SULFATE
          TABLET; ORAL
            DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
>A>   AB      MALLINCKRODT            1.25MG;1.25MG;1.25MG;1.25MG              N40440 001  OCT 07, 2003  OCT  NEWA
>A>   AB                              1.875MG;1.875MG;1.875MG;1.875MG          N40440 002  OCT 07, 2003  OCT  NEWA
>A>   AB                              2.5MG;2.5MG;2.5MG;2.5MG                  N40440 003  OCT 07, 2003  OCT  NEWA
>A>   AB                              3.125MG;3.125MG;3.125MG;3.125MG          N40440 004  OCT 07, 2003  OCT  NEWA
>A>   AB                              3.75MG;3.75MG;3.75MG;3.75MG              N40440 005  OCT 07, 2003  OCT  NEWA
>A>   AB                              5MG;5MG;5MG;5MG                          N40440 006  OCT 07, 2003  OCT  NEWA
>A>   AB                              7.5MG;7.5MG;7.5MG;7.5MG                  N40440 007  OCT 07, 2003  OCT  NEWA

        AMPICILLIN SODIUM
          INJECTABLE; INJECTION
            AMPICILLIN SODIUM
>D>   AP      APOTHECON               EQ 125MG BASE/VIAL                       N62860 001  FEB 05, 1988  OCT  WDGA
>A>         @                         EQ 125MG BASE/VIAL                       N62860 001  FEB 05, 1988  OCT  WDGA
>D>   AP                              EQ 250MG BASE/VIAL                       N62860 002  FEB 05, 1988  OCT  WDGA
>A>         @                         EQ 250MG BASE/VIAL                       N62860 002  FEB 05, 1988  OCT  WDGA
>D>   AP                              EQ 500MG BASE/VIAL                       N62860 003  FEB 05, 1988  OCT  WDGA
>A>         @                         EQ 500MG BASE/VIAL                       N62860 003  FEB 05, 1988  OCT  WDGA 
>D>   AP                              EQ 1GM BASE/VIAL                         N62860 004  FEB 05, 1988  OCT  WDGA
>A>         @                         EQ 1GM BASE/VIAL                         N62860 004  FEB 05, 1988  OCT  WDGA
>D>   AP                              EQ 2GM BASE/VIAL                         N62860 005  FEB 05, 1988  OCT  WDGA
>A>         @                         EQ 2GM BASE/VIAL                         N62860 005  FEB 05, 1988  OCT  WDGA

        ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
          INJECTABLE; INJECTION
            ATROPINE AND DEMEROL
>D>       +   ABBOTT                  0.4MG/ML;75MG/ML                         N87847 001  NOV 26, 1982  OCT  WDGA
>A>         @                         0.4MG/ML;75MG/ML                         N87847 001  NOV 26, 1982  OCT  WDGA
>D>       +                           0.4MG/ML;100MG/ML                        N87848 001  NOV 26, 1982  OCT  WDGA
>A>         @                         0.4MG/ML;100MG/ML                        N87848 001  NOV 26, 1982  OCT  WDGA
>D>       +                           0.4MG/ML;50MG/ML                         N87853 001  NOV 26, 1982  OCT  WDGA
>A>         @                         0.4MG/ML;50MG/ML                         N87853 001  NOV 26, 1982  OCT  WDGA

        BACLOFEN
>A>       TABLET, ORALLY DISINTEGRATING; ORAL
>A>         BACLOFEN
>A>           SCHWARZ PHARMA          10MG                                     N21589 001  OCT 30, 2003  OCT  NEWA
>A>       +                           20MG                                     N21589 002  OCT 30, 2003  OCT  NEWA

        BIVALIRUDIN
          INJECTABLE; INTRAVENOUS
            ANGIOMAX
>A>       +   MEDICINES CO            250MG/VIAL                               N20873 001  DEC 15, 2000  OCT  CAHN 
>D>       +   MEDS (TMC)              250MG/VIAL                               N20873 001  DEC 15, 2000  OCT  CAHN

        BUPROPION HYDROCHLORIDE
          TABLET, EXTENDED RELEASE; ORAL
            WELLBUTRIN SR
>D>           GLAXOSMITHKLINE         150MG                                    N20358 003  OCT 04, 1996  OCT  CRLD
>A>       +                           150MG                                    N20358 003  OCT 04, 1996  OCT  CRLD
>D>       +                           200MG                                    N20358 004  JUN 14, 2002  OCT  CRLD
>A>                                   200MG                                    N20358 004  JUN 14, 2002  OCT  CRLD


        CEFACLOR
          CAPSULE; ORAL
            CEFACLOR
>D>   AB      CEPH INTL               EQ 250MG BASE                            N62205 001                OCT  CTNA
>A>   AB                              EQ 250MG BASE                            N62205 001                OCT  CTNA
>D>   AB                              EQ 500MG BASE                            N62205 002                OCT  CTNA
>A>   AB                              EQ 500MG BASE                            N62205 002                OCT  CTNA

        CEFADROXIL/CEFADROXIL HEMIHYDRATE
          CAPSULE; ORAL
            CEFADROXIL
>D>   AB      BARR                    EQ 500MG BASE                            N65015 001  JUN 22, 1999  OCT  CAHN
>A>   AB      RANBAXY                 EQ 500MG BASE                            N65015 001  JUN 22, 1999  OCT  CAHN

        CEFAZOLIN SODIUM
          INJECTABLE; INJECTION
            CEFAZOLIN SODIUM
>A>   AP      HIKMA FARMACEUTICA      EQ 500MG BASE/VIAL                       N65047 001  SEP 18, 2001  OCT  CAHN
>A>   AP                              EQ 1GM BASE/VIAL                         N65047 002  SEP 18, 2001  OCT  CAHN
>D>   AP      WESTWARD                EQ 500MG BASE/VIAL                       N65047 001  SEP 18, 2001  OCT  CAHN
>D>   AP                              EQ 1GM BASE/VIAL                         N65047 002  SEP 18, 2001  OCT  CAHN

        CEFUROXIME AXETIL
          TABLET; ORAL
            CEFUROXIME AXETIL
>A>   AB      BIOCHEMIE US            EQ 250MG BASE                            N65126 001  OCT 28, 2003  OCT  NEWA
>A>   AB                              EQ 500MG BASE                            N65126 002  OCT 28, 2003  OCT  NEWA

        CEPHALEXIN
          CAPSULE; ORAL
            CEPHALEXIN
>D>   AB      CEPH INTL               EQ 250MG BASE                            N62118 001                OCT  CTNA
>A>   AB                              EQ 250MG BASE                            N62118 001                OCT  CTNA
>D>   AB                              EQ 500MG BASE                            N62118 002                OCT  CTNA
>A>   AB                              EQ 500MG BASE                            N62118 002                OCT  CTNA
>D>   AB      TEVA                    EQ 250MG BASE                            N62821 001  FEB 05, 1988  OCT  WDGA
>A>         @                         EQ 250MG BASE                            N62821 001  FEB 05, 1988  OCT  WDGA
          FOR SUSPENSION; ORAL
>D>       +   CEPH INTL               EQ 100MG BASE/ML                         N62117 001                OCT  CTNA
>A>       +                           EQ 100MG BASE/ML                         N62117 001                OCT  CTNA
>D>   AB                              EQ 125MG BASE/5ML                        N62117 002                OCT  CTNA
>A>   AB                              EQ 125MG BASE/5ML                        N62117 002                OCT  CTNA
>D>   AB  +                           EQ 250MG BASE/5ML                        N62117 003                OCT  CTNA
>A>   AB  +                           EQ 250MG BASE/5ML                        N62117 003                OCT  CTNA



        CHLORAMBUCIL
          TABLET; ORAL
            LEUKERAN
>D>       +   GLAXOSMITHKLINE         2MG                                      N10669 002                OCT  CAHN
>A>       +   SMITHKLINE BEECHAM      2MG                                      N10669 002                OCT  CAHN

        CHLORTHALIDONE
          TABLET; ORAL
            CHLORTHALIDONE
>D>   AB      MYLAN                   50MG                                     N86831 001                OCT  CRLD
>A>   AB  +                           50MG                                     N86831 001                OCT  CRLD

>D>         HYGROTON
>D>   AB      AVENTIS PHARMS          25MG                                     N12283 004                OCT  DISC
>A>         @                         25MG                                     N12283 004                OCT  DISC
>D>   AB  +                           50MG                                     N12283 003                OCT  DISC
>A>         @                         50MG                                     N12283 003                OCT  DISC

        CILOSTAZOL
          TABLET; ORAL
            PLETAL
>D>           OTSUKA                  50MG                                     N20863 001  JAN 15, 1999  OCT  CRLD
>A>       +                           50MG                                     N20863 001  JAN 15, 1999  OCT  CRLD

        CYCLOSPORINE
          INJECTABLE; INJECTION
            CYCLOSPORINE
>A>   AP      PHARMAFORCE             50MG/ML                                  N65151 001  OCT 07, 2003  OCT  NEWA

        DEMECLOCYCLINE HYDROCHLORIDE
          TABLET; ORAL
            DECLOMYCIN
>A>         @ ESP PHARMA              75MG                                     N50261 001                OCT  CAHN
>A>                                   150MG                                    N50261 002                OCT  CAHN
>A>       +                           300MG                                    N50261 003                OCT  CAHN
>D>         @ WYETH PHARMS INC        75MG                                     N50261 001                OCT  CAHN
>D>                                   150MG                                    N50261 002                OCT  CAHN
>D>       +                           300MG                                    N50261 003                OCT  CAHN

        DEXCHLORPHENIRAMINE MALEATE
          SYRUP; ORAL
            MYLARAMINE
>D>   AA      MORTON GROVE            2MG/5ML                                  N88251 001  MAR 23, 1984  OCT  CRLD
>A>       +                           2MG/5ML                                  N88251 001  MAR 23, 1984  OCT  CRLD
>D>         POLARAMINE
>D>   AA      SCHERING                2MG/5ML                                  N86837 001  JUL 19, 1982  OCT  DISC
>A>         @                         2MG/5ML                                  N86837 001  JUL 19, 1982  OCT  DISC
          TABLET; ORAL
            DEXCHLORPHENIRAMINE MALEATE
>D>   AA      PLIVA                   2MG                                      N88682 001  JAN 17, 1986  OCT  CRLD
>A>       +                           2MG                                      N88682 001  JAN 17, 1986  OCT  CRLD
>D>         POLARAMINE
>D>   AA  +   SCHERING                2MG                                      N86835 001                OCT  DISC
>A>         @                         2MG                                      N86835 001                OCT  DISC

        DIAZEPAM
          GEL; RECTAL
            DIASTAT
>D>       +   XCEL PHARMS             2.5MG/0.5ML                              N20648 001  JUL 29, 1997  OCT  CRLD
>A>                                   2.5MG/0.5ML                              N20648 001  JUL 29, 1997  OCT  CRLD

        DILTIAZEM HYDROCHLORIDE
          CAPSULE, EXTENDED RELEASE; ORAL
            CARDIZEM CD
>A>   BC  +   AVENTIS PHARMS          360MG                                    N20062 005  AUG 24, 1999  OCT  NEWA

        DOXYCYCLINE
          CAPSULE; ORAL
            DOXYCYCLINE
>A>       +   RANBAXY                 EQ 75MG BASE                             N65053 003  SEP 10, 2003  OCT  NEWA

>A>     EPINASTINE HYDROCHLORIDE
>A>       SOLUTION/DROPS; OPHTHALMIC
>A>         ELESTAT
>A>       +   ALLERGAN                0.05%                                    N21565 001  OCT 16, 2003  OCT  NEWA

        EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE
          INJECTABLE; INJECTION
            DURANEST
>D>       +   ASTRAZENECA             0.005MG/ML;1%                            N17751 006                OCT  WDGA
>A>         @                         0.005MG/ML;1%                            N17751 006                OCT  WDGA

        ESTRADIOL HEMIHYDRATE
>A>       EMULSION; TOPICAL
>A>         ESTRASORB
>A>       +   NOVAVAX                 0.25%                                    N21371 001  OCT 09, 2003  OCT  NEWA

        FENOFIBRATE
          CAPSULE; ORAL
>A>         FENOFIBRATE (MICRONIZED)
>A>   AB      IMPAX LABS              67MG                                     N75868 001  OCT 27, 2003  OCT  NEWA
>A>   AB                              134MG                                    N75868 002  OCT 27, 2003  OCT  NEWA
>A>   AB                              200MG                                    N75868 003  OCT 27, 2003  OCT  NEWA
>D>           TEVA                    67MG                                     N75753 001  SEP 03, 2002  OCT  CFTG
>A>   AB                              67MG                                     N75753 001  SEP 03, 2002  OCT  CFTG
>D>                                   134MG                                    N75753 002  APR 09, 2002  OCT  CFTG
>A>   AB                              134MG                                    N75753 002  APR 09, 2002  OCT  CFTG
>D>       +                           200MG                                    N75753 003  APR 09, 2002  OCT  CFTG
>A>   AB  +                           200MG                                    N75753 003  APR 09, 2002  OCT  CFTG

>A>     FERRIC HEXACYANOFERRATE(II)
>A>       CAPSULE; ORAL
>A>         RADIOGARDASE (PRUSSIAN BLUE)
>A>       +   HEYDT                   500MG                                    N21626 001  OCT 02, 2003  OCT  NEWA

        FLURANDRENOLIDE
          LOTION; TOPICAL 
            CORDRAN
>D>       +   OCLASSEN                0.05%                                    N13790 001                OCT  CAHN
>A>       +   WATSON LABS             0.05%                                    N13790 001                OCT  CAHN

>A>     FOSAMPRENAVIR CALCIUM
>A>       TABLET; ORAL
>A>         LEXIVA
>A>       +   GLAXOSMITHKLINE         EQ 700MG BASE                            N21548 001  OCT 20, 2003  OCT  NEWA

        GADOTERIDOL
          INJECTABLE; INJECTION
>A>         PROHANCE MULTIPACK
>A>       +   BRACCO                  279.3MG/ML                               N21489 001  OCT 09, 2003  OCT  NEWA

        GLYBURIDE
          TABLET; ORAL
            GLYBURIDE (MICRONIZED)
>D>   AB      AVENTIS PHARMS          1.5MG                                    N20055 001  APR 17, 1992  OCT  DISC
>A>         @                         1.5MG                                    N20055 001  APR 17, 1992  OCT  DISC
>D>   AB                              3MG                                      N20055 002  APR 17, 1992  OCT  DISC
>A>         @                         3MG                                      N20055 002  APR 17, 1992  OCT  DISC
>D>   AB                              6MG                                      N20055 003  MAR 08, 2000  OCT  DISC
>A>         @                         6MG                                      N20055 003  MAR 08, 2000  OCT  DISC

        GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
          SOLUTION/DROPS; OPHTHALMIC
            NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
>D>   AT      BAUSCH AND LOMB         0.025MG/ML;EQ 1.75MG BASE/ML;10,000
                                      UNITS/ML                                 N64047 001  JAN 31, 1996  OCT  CRLD
>A>   AT  +                           0.025MG/ML;EQ 1.75MG BASE/ML;10,000
                                      UNITS/ML                                 N64047 001  JAN 31, 1996  OCT  CRLD
        HEPARIN SODIUM
          INJECTABLE; INJECTION
>D>         SODIUM HEPARIN
>D>   AP      BAXTER HLTHCARE         1,000 UNITS/ML                           N17036 001  MAR 04, 1988  OCT  DISC
>A>         @                         1,000 UNITS/ML                           N17036 001  MAR 04, 1988  OCT  DISC

        HYDROCORTISONE; POLYMYXIN B SULFATE
          SOLUTION/DROPS; OTIC
            OTOBIOTIC
>D>       +   SCHERING                5MG/ML;EQ 10,000 UNITS BASE/ML           N62302 001                OCT  WDGA
>A>         @                         5MG/ML;EQ 10,000 UNITS BASE/ML           N62302 001                OCT  WDGA

        HYDROXYZINE PAMOATE
          SUSPENSION; ORAL
            VISTARIL
>D>           PFIZER                  EQ 25MG HCL/5ML                          N11795 001                OCT  CRLD
>A>       +                           EQ 25MG HCL/5ML                          N11795 001                OCT  CRLD

        ISOSORBIDE DINITRATE
          TABLET; ORAL
            ISORDIL
>D>   AB      BIOVAIL                 40MG                                     N12093 001  JUL 29, 1988  OCT  CRLD
>A>       +                           40MG                                     N12093 001  JUL 29, 1988  OCT  CRLD
            SORBITRATE
>D>   AB      ASTRAZENECA             20MG                                     N86405 002  AUG 21, 1990  OCT  WDGA
>A>         @                         20MG                                     N86405 002  AUG 21, 1990  OCT  WDGA
>D>   AB                              40MG                                     N88125 001  AUG 21, 1990  OCT  WDGA
>A>         @                         40MG                                     N88125 001  AUG 21, 1990  OCT  WDGA
          TABLET, CHEWABLE; ORAL
>D>       +   ASTRAZENECA             10MG                                     N16776 003  APR 01, 1996  OCT  WDGA
>A>         @                         10MG                                     N16776 003  APR 01, 1996  OCT  WDGA

        ISOSORBIDE MONONITRATE
          TABLET, EXTENDED RELEASE; ORAL
            IMDUR
>D>   AB  +   SCHERING                30MG                                     N20225 001  AUG 12, 1993  OCT  CAHN
>D>   AB  +                           60MG                                     N20225 002  AUG 12, 1993  OCT  CAHN
>D>   AB  +                           120MG                                    N20225 003  MAR 30, 1995  OCT  CAHN
>A>   AB  +   SCHERING PLOUGH         30MG                                     N20225 001  AUG 12, 1993  OCT  CAHN
>A>   AB  +                           60MG                                     N20225 002  AUG 12, 1993  OCT  CAHN
>A>   AB  +                           120MG                                    N20225 003  MAR 30, 1995  OCT  CAHN

        KETOROLAC TROMETHAMINE
          INJECTABLE; INJECTION
            KETOROLAC TROMETHAMINE
>D>   AP      ABBOTT                  15MG/ML                                  N74801 001  JUN 05, 1997  OCT  DISC
>A>         @                         15MG/ML                                  N74801 001  JUN 05, 1997  OCT  DISC
>D>   AP                              30MG/ML                                  N74801 002  JUN 05, 1997  OCT  DISC
>A>         @                         30MG/ML                                  N74801 002  JUN 05, 1997  OCT  DISC
>D>   AP      BEDFORD                 30MG/ML                                  N75228 001  APR 26, 1999  OCT  CRLD
>A>   AP  +                           30MG/ML                                  N75228 001  APR 26, 1999  OCT  CRLD

        LABETALOL HYDROCHLORIDE
          TABLET; ORAL
            LABETALOL HCL
>D>   AB      APOTHECON               100MG                                    N75223 001  NOV 20, 1998  OCT  WDGA
>A>         @                         100MG                                    N75223 001  NOV 20, 1998  OCT  WDGA
>D>   AB                              200MG                                    N75223 002  NOV 20, 1998  OCT  WDGA
>A>         @                         200MG                                    N75223 002  NOV 20, 1998  OCT  WDGA
>D>   AB                              300MG                                    N75223 003  NOV 20, 1998  OCT  WDGA
>A>         @                         300MG                                    N75223 003  NOV 20, 1998  OCT  WDGA

        LEUCOVORIN CALCIUM
          FOR SOLUTION; ORAL
            LEUCOVORIN CALCIUM
>A>         @ FAULDING                EQ 60MG BASE/VIAL                        N08107 003  JAN 30, 1987  OCT  CAHN
>D>         @ XANODYNE PHARM          EQ 60MG BASE/VIAL                        N08107 003  JAN 30, 1987  OCT  CAHN
          INJECTABLE; INJECTION
>A>         @ FAULDING                EQ 3MG BASE/ML                           N08107 001                OCT  CAHN
>A>   AP  +                           EQ 50MG BASE/VIAL                        N08107 002                OCT  CAHN
>A>   AP  +                           EQ 100MG BASE/VIAL                       N08107 004  MAY 23, 1988  OCT  CAHN
>A>   AP  +                           EQ 350MG BASE/VIAL                       N08107 005  APR 05, 1989  OCT  CAHN 
>D>         @ XANODYNE PHARM          EQ 3MG BASE/ML                           N08107 001                OCT  CAHN
>D>   AP  +                           EQ 50MG BASE/VIAL                        N08107 002                OCT  CAHN
>D>   AP  +                           EQ 100MG BASE/VIAL                       N08107 004  MAY 23, 1988  OCT  CAHN
>D>   AP  +                           EQ 350MG BASE/VIAL                       N08107 005  APR 05, 1989  OCT  CAHN

        LEVOFLOXACIN
          INJECTABLE; INJECTION
            LEVAQUIN
>D>       +   ORTHO MCNEIL PHARM      EQ 500MG /20ML(25MG/ML)                  N20635 001  DEC 20, 1996  OCT  CPOT
>A>       +                           EQ 500MG /20ML(25MG/ML)                  N20635 001  DEC 20, 1996  OCT  CPOT
>A>       +                           EQ 750MG /30ML(25MG/ML)                  N20635 004  DEC 20, 1996  OCT  NEWA
            LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
>D>       +   ORTHO MCNEIL PHARM      EQ 250MG /50ML(5MG/ML)                   N20635 002  DEC 20, 1996  OCT  CPOT
>A>       +                           EQ 250MG /50ML(5MG/ML)                   N20635 002  DEC 20, 1996  OCT  CPOT
>D>       +                           EQ 500MG 100ML/(5MG/ML)                  N20635 003  DEC 20, 1996  OCT  CPOT
>A>       +                           EQ 500MG 100ML/(5MG/ML)                  N20635 003  DEC 20, 1996  OCT  CPOT
>A>       +                           EQ 750MG /150ML(5MG/ML)                  N20635 005  DEC 20, 1996  OCT  NEWA

>A>     MEMANTINE HYDROCHLORIDE
>A>       TABLET; ORAL
>A>         NAMENDA
>A>           FOREST LABS             5MG                                      N21487 001  OCT 16, 2003  OCT  NEWA
>A>       +                           10MG                                     N21487 002  OCT 16, 2003  OCT  NEWA
>A>         @                         15MG                                     N21487 003  OCT 16, 2003  OCT  DISC
>A>         @                         20MG                                     N21487 004  OCT 16, 2003  OCT  DISC
>D>                                   15MG                                     N21487 003  OCT 16, 2003  OCT  DISC
>D>                                   20MG                                     N21487 004  OCT 16, 2003  OCT  DISC

        METHACHOLINE CHLORIDE
          FOR SOLUTION; INHALATION
            PROVOCHOLINE
>D>           METHAPHARM              100MG/VIAL                               N19193 001  OCT 31, 1986  OCT  CRLD
>A>       +                           100MG/VIAL                               N19193 001  OCT 31, 1986  OCT  CRLD

        METHOTREXATE SODIUM
          INJECTABLE; INJECTION
            METHOTREXATE LPF
>A>   AP  +   FAULDING                EQ 25MG BASE/ML                          N11719 007  MAR 31, 1982  OCT  CAHN
>D>   AP  +   WYETH PHARMS INC        EQ 25MG BASE/ML                          N11719 007  MAR 31, 1982  OCT  CAHN

            METHOTREXATE SODIUM
>A>         @ FAULDING                EQ 2.5MG BASE/ML                         N11719 004                OCT  CAHN
>A>       +                           EQ 20MG BASE/VIAL                        N11719 001                OCT  CAHN
>A>   AP  +                           EQ 25MG BASE/ML                          N11719 005                OCT  CAHN
>A>         @                         EQ 50MG BASE/VIAL                        N11719 003                OCT  CAHN
>A>         @                         EQ 100MG BASE/VIAL                       N11719 006                OCT  CAHN
>D>         @ WYETH PHARMS INC        EQ 2.5MG BASE/ML                         N11719 004                OCT  CAHN
>D>       +                           EQ 20MG BASE/VIAL                        N11719 001                OCT  CAHN
>D>   AP  +                           EQ 25MG BASE/ML                          N11719 005                OCT  CAHN
>D>         @                         EQ 50MG BASE/VIAL                        N11719 003                OCT  CAHN
>D>         @                         EQ 100MG BASE/VIAL                       N11719 006                OCT  CAHN

            METHOTREXATE SODIUM PRESERVATIVE FREE
>A>   AP  +   FAULDING                EQ 1GM BASE/VIAL                         N11719 009  APR 07, 1988  OCT  CAHN
>D>   AP  +   WYETH PHARMS INC        EQ 1GM BASE/VIAL                         N11719 009  APR 07, 1988  OCT  CAHN

        METHYLPHENIDATE HYDROCHLORIDE
          TABLET, EXTENDED RELEASE; ORAL
            CONCERTA
>D>       +   MCNEIL CONS SPECLT      18MG                                     N21121 001  AUG 01, 2000  OCT  CRLD
>A>                                   18MG                                     N21121 001  AUG 01, 2000  OCT  CRLD
>D>       +                           27MG                                     N21121 004  APR 01, 2002  OCT  CRLD
>A>                                   27MG                                     N21121 004  APR 01, 2002  OCT  CRLD
>D>       +                           36MG                                     N21121 002  AUG 01, 2000  OCT  CRLD
>A>                                   36MG                                     N21121 002  AUG 01, 2000  OCT  CRLD

        MINOCYCLINE HYDROCHLORIDE
          CAPSULE; ORAL
            VECTRIN
>D>         @ MEDICIS                 EQ 75MG BASE                             N63067 002  SEP 15, 1999  OCT  CMFD
>A>   AB                              EQ 75MG BASE                             N63067 002  SEP 15, 1999  OCT  CMFD
>D>         @                         EQ 100MG BASE                            N63067 001  JUL 31, 1990  OCT  CMFD
>A>   AB                              EQ 100MG BASE                            N63067 001  JUL 31, 1990  OCT  CMFD

        NAFTIFINE HYDROCHLORIDE
          CREAM; TOPICAL
            NAFTIN
>D>         @ ALLERGAN HERBERT        1%                                       N19599 001  FEB 29, 1988  OCT  CMFD
>A>                                   1%                                       N19599 001  FEB 29, 1988  OCT  CMFD
          GEL; TOPICAL
>D>         @ ALLERGAN HERBERT        1%                                       N19356 001  JUN 18, 1990  OCT  CMFD
>A>       +                           1%                                       N19356 001  JUN 18, 1990  OCT  CMFD

        NAPROXEN SODIUM
          TABLET; ORAL
            NAPROXEN SODIUM
>D>   AB      AL HIKMA                EQ 250MG BASE                            N74480 002  FEB 18, 1998  OCT  CAHN
>D>   AB                              EQ 500MG BASE                            N74480 001  MAY 14, 1996  OCT  CAHN
>A>   AB      HIKMA                   EQ 250MG BASE                            N74480 002  FEB 18, 1998  OCT  CAHN
>A>   AB                              EQ 500MG BASE                            N74480 001  MAY 14, 1996  OCT  CAHN

        NOREPINEPHRINE BITARTRATE
          INJECTABLE; INJECTION
            NOREPINEPHRINE BITARTRATE
>A>   AP      BEDFORD                 EQ 1MG BASE/ML                           N40462 001  OCT 31, 2003  OCT  NEWA

        OMEPRAZOLE
          CAPSULE, DELAYED REL PELLETS; ORAL 
            OMEPRAZOLE
>A>   AB      TORPHARM                10MG                                     N76048 001  OCT 06, 2003  OCT  NEWA
>A>   AB                              20MG                                     N76048 002  OCT 06, 2003  OCT  NEWA 
        OXYCODONE HYDROCHLORIDE
          TABLET; ORAL
            ROXICODONE
>D>           ELAN PHARMS             15MG                                     N21011 001  AUG 31, 2000  OCT  CRLD
>A>       +                           15MG                                     N21011 001  AUG 31, 2000  OCT  CRLD
>D>       +                           30MG                                     N21011 002  AUG 31, 2000  OCT  CRLD
>A>                                   30MG                                     N21011 002  AUG 31, 2000  OCT  CRLD

        PHENTERMINE HYDROCHLORIDE
          CAPSULE; ORAL
            PHENTERMINE HCL
>A>   AA      MUTUAL PHARM            30MG                                     N40525 001  OCT 23, 2003  OCT  NEWA
>A>   AA                              37.5MG                                   N40527 001  OCT 23, 2003  OCT  NEWA
          TABLET; ORAL
>A>   AA      MUTUAL PHARM            37.5MG                                   N40526 001  OCT 23, 2003  OCT  NEWA

        PIROXICAM
          CAPSULE; ORAL
            PIROXICAM
>D>   AB      SCS                     10MG                                     N74036 001  MAY 29, 1992  OCT  WDGA
>A>         @                         10MG                                     N74036 001  MAY 29, 1992  OCT  WDGA
>D>   AB                              20MG                                     N74036 002  MAY 29, 1992  OCT  WDGA
>A>         @                         20MG                                     N74036 002  MAY 29, 1992  OCT  WDGA

        PRAMIPEXOLE DIHYDROCHLORIDE
          TABLET; ORAL
            MIRAPEX
>D>           PHARMACIA AND UPJOHN    0.25MG                                   N20667 002  JUL 01, 1997  OCT  CRLD
>A>       +                           0.25MG                                   N20667 002  JUL 01, 1997  OCT  CRLD
>D>       +                           1.5MG                                    N20667 005  JUL 01, 1997  OCT  CRLD
>A>                                   1.5MG                                    N20667 005  JUL 01, 1997  OCT  CRLD

        PROCAINE HYDROCHLORIDE
          INJECTABLE; INJECTION
            PROCAINE HCL
>D>   AP      AM PHARM PARTNERS       1%                                       N80421 001                OCT  DISC
>A>         @                         1%                                       N80421 001                OCT  DISC
>D>   AP                              2%                                       N80421 002                OCT  DISC
>A>         @                         2%                                       N80421 002                OCT  DISC
>D>   AP      ELKINS SINN             1%                                       N83315 001                OCT  DISC
>A>         @                         1%                                       N83315 001                OCT  DISC
>D>   AP                              2%                                       N83315 002                OCT  DISC
>A>         @                         2%                                       N83315 002                OCT  DISC
>D>   AP      STERIS                  2%                                       N80658 002                OCT  DISC
>A>         @                         2%                                       N80658 002                OCT  DISC

        PYRIDOSTIGMINE BROMIDE
          INJECTABLE; INJECTION
            REGONOL
>D>         @ SABEX 2002              5MG/ML                                   N17398 001                OCT  CMFD
>A>   AP                              5MG/ML                                   N17398 001                OCT  CMFD
          TABLET; ORAL
            PYRIDOSTIGMINE BROMIDE
>A>   AB      BARR                    60MG                                     N40512 001  OCT 08, 2003  OCT  NEWA

        RANITIDINE HYDROCHLORIDE
          CAPSULE; ORAL
            RANITIDINE HCL
>A>   AB      TEVA                    EQ 150MG BASE                            N75557 001  OCT 31, 2003  OCT  NEWA
>A>   AB                              EQ 300MG BASE                            N75557 002  OCT 31, 2003  OCT  NEWA

        RISPERIDONE
>A>       INJECTABLE; INTRAMUSCULAR
>A>         RISPERDAL CONSTA
>A>           JOHNSON AND JOHNSON     25MG/VIAL                                N21346 001  OCT 29, 2003  OCT  NEWA
>A>                                   37.5MG/VIAL                              N21346 002  OCT 29, 2003  OCT  NEWA
>A>       +                           50MG/VIAL                                N21346 003  OCT 29, 2003  OCT  NEWA

        SILDENAFIL CITRATE
          TABLET; ORAL
            VIAGRA
>D>           PFIZER                  25MG                                     N20895 001  MAR 27, 1998  OCT  CAHN
>D>                                   50MG                                     N20895 002  MAR 27, 1998  OCT  CAHN
>D>       +                           100MG                                    N20895 003  MAR 27, 1998  OCT  CAHN
>A>           PFIZER IRELAND          25MG                                     N20895 001  MAR 27, 1998  OCT  CAHN
>A>                                   50MG                                     N20895 002  MAR 27, 1998  OCT  CAHN
>A>       +                           100MG                                    N20895 003  MAR 27, 1998  OCT  CAHN

        TESTOSTERONE ENANTHATE
          INJECTABLE; INJECTION
            DELATESTRYL
>D>         @ BTG                     200MG/ML                                 N09165 001                OCT  CAHN
>D>   AO  +                           200MG/ML                                 N09165 003                OCT  CAHN
>A>         @ SAVIENT PHARMS          200MG/ML                                 N09165 001                OCT  CAHN
>A>   AO  +                           200MG/ML                                 N09165 003                OCT  CAHN

        TETRACYCLINE HYDROCHLORIDE
          CAPSULE; ORAL
            TETRACYCLINE HCL
>D>   AB      ROXANE                  500MG                                    N61214 002                OCT  DISC
>A>         @                         500MG                                    N61214 002                OCT  DISC

        THALLOUS CHLORIDE, TL-201
          INJECTABLE; INTRAVENOUS
            THALLOUS CHLORIDE TL 201
>A>       +   BRISTOL MYERS SQUIBB    2mCi/ML                                  N17806 002  OCT 09, 1998  OCT  NEWA

        TIROFIBAN HYDROCHLORIDE
          INJECTABLE; INJECTION
            AGGRASTAT
>A>       +   GUILFORD PHARMS         EQ 0.05MG BASE/ML                        N20913 001  MAY 14, 1998  OCT  CAHN
>A>       +                           EQ 0.25MG BASE/ML                        N20912 001  MAY 14, 1998  OCT  CAHN
>D>       +   MERCK                   EQ 0.05MG BASE/ML                        N20913 001  MAY 14, 1998  OCT  CAHN
>D>       +                           EQ 0.25MG BASE/ML                        N20912 001  MAY 14, 1998  OCT  CAHN

        TIZANIDINE HYDROCHLORIDE
          TABLET; ORAL
            TIZANIDINE HCL
>A>   AB      AMIDE PHARM             EQ 2MG BASE                              N76281 001  OCT 20, 2003  OCT  NEWA
>A>   AB                              EQ 4MG BASE                              N76281 002  OCT 20, 2003  OCT  NEWA

        TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)
          CREAM; VAGINAL
>D>         GYNE-SULF
>D>   AT      G AND W LABS            3.7%;2.86%;3.42%                         N88607 001  JUN 09, 1986  OCT  DISC
>A>         @                         3.7%;2.86%;3.42%                         N88607 001  JUN 09, 1986  OCT  DISC
            TRIPLE SULFA
>D>   AT      ALPHARMA                3.7%;2.86%;3.42%                         N87864 001  SEP 01, 1982  OCT  WDGA
>A>         @                         3.7%;2.86%;3.42%                         N87864 001  SEP 01, 1982  OCT  WDGA
>D>   AT      CLAY PARK               3.7%;2.86%;3.42%                         N87285 001  NOV 15, 1982  OCT  DISC
>A>         @                         3.7%;2.86%;3.42%                         N87285 001  NOV 15, 1982  OCT  DISC
>D>         TRYSUL
>D>   AT      SAVAGE LABS             3.7%;2.86%;3.42%                         N87887 001  JUL 23, 1982  OCT  DISC
>A>         @                         3.7%;2.86%;3.42%                         N87887 001  JUL 23, 1982  OCT  DISC

        VINCRISTINE SULFATE
          INJECTABLE; INJECTION
            VINCRISTINE SULFATE
>A>   AP      AM PHARM                1MG/ML                                   N76401 001  OCT 28, 2003  OCT  NEWA
>D>       +   AM PHARM PARTNERS       1MG/ML                                   N76296 001  DEC 20, 2002  OCT  CTEC
>A>   AP  +                           1MG/ML                                   N76296 001  DEC 20, 2002  OCT  CTEC

        WARFARIN SODIUM
          TABLET; ORAL
>A>         JANTOVEN
>A>   AB      USL PHARMA              1MG                                      N40416 001  OCT 02, 2003  OCT  NEWA
>A>   AB                              2MG                                      N40416 002  OCT 02, 2003  OCT  NEWA
>A>   AB                              2.5MG                                    N40416 003  OCT 02, 2003  OCT  NEWA
>A>   AB                              3MG                                      N40416 004  OCT 02, 2003  OCT  NEWA
>A>   AB                              4MG                                      N40416 005  OCT 02, 2003  OCT  NEWA
>A>   AB                              5MG                                      N40416 006  OCT 02, 2003  OCT  NEWA
>A>   AB                              6MG                                      N40416 007  OCT 02, 2003  OCT  NEWA
>A>   AB                              7.5MG                                    N40416 008  OCT 02, 2003  OCT  NEWA
>A>   AB                              10MG                                     N40416 009  OCT 02, 2003  OCT  NEWA


 

ADDITIONS/DELETIONS FOR OTC DRUG PRODUCT LIST


        ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE
          TABLET, CHEWABLE; ORAL
            FOAMICON
>D>           NOVARTIS                80MG;20MG                                N72687 001  JUN 28, 1989  OCT  WDGA
>A>         @                         80MG;20MG                                N72687 001  JUN 28, 1989  OCT  WDGA
        LORATADINE; PSEUDOEPHEDRINE SULFATE
          TABLET, EXTENDED RELEASE; ORAL
            LORATADINE AND PSEUDOEPHEDRINE SULFATE
>D>           ANDRX PHARMS            10MG;240MG                               N75706 001  FEB 21, 2003  OCT  CTNA
>A>                                   10MG;240MG                               N75706 001  FEB 21, 2003  OCT  CTNA

        NICOTINE
          FILM, EXTENDED RELEASE; TRANSDERMAL
            PROSTEP
>A>       +   AVEVA                   11MG/24HR                                N19983 003  DEC 23, 1998  OCT  CAHN
>A>       +                           22MG/24HR                                N19983 004  DEC 23, 1998  OCT  CAHN
>D>       +   ELAN PHARM              11MG/24HR                                N19983 003  DEC 23, 1998  OCT  CAHN
>D>       +                           22MG/24HR                                N19983 004  DEC 23, 1998  OCT  CAHN


  

 

Back to Top     Index Page

Date updated: November 21, 2003

horizonal rule