[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 - 20th Edition
Cumulative Supplement Number 5: May 2000

[Prescription - OTC]



ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST

 
          ACETAMINOPHEN; HYDROCODONE BITARTRATE                             > ADD >   ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN;
                                                                            > ADD >    CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID;
            TABLET; ORAL                                                    > ADD >    NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN PHOSPHATE
              HYDROCODONE BITARTRATE AND ACETAMINOPHEN                      > ADD >    SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE
> ADD >  AA     VINTAGE PHARMS       325MG;10MG                N40355 001
> ADD >                                                      MAY 31, 2000   > ADD >     INJECTABLE; INJECTION
> ADD >  AA                          500MG;10MG                N40356 001   > ADD >       MULTI-12
> ADD >                                                      MAY 31, 2000   > ADD >      +  SABEX                2 IU/ML;20MG/ML;12 UGM/ML;40 IU/ML;
> ADD >  AA                          660MG;10MG                N40358 001   > ADD >                              1 UGM/ML;3MG/ML;80 UGM/ML;8MG/ML;
> ADD >                                                      MAY 31, 2000   > ADD >                              0.8MG/ML;0.72MG/ML;0.6MG/ML;
                                                                            > ADD >                              600 IU/ML                 N21163 001
                                                                            > ADD >                                                      MAY 18, 2000
          ACETOHEXAMIDE

            TABLET; ORAL                                                              AMINO ACIDS
> DLT >       DYMELOR
> DLT >  AB     LILLY                250MG                     N13378 002               INJECTABLE; INJECTION
> DLT >  AB  +                       500MG                     N13378 001                 TROPHAMINE
> ADD >       @                      250MG                     N13378 002   > DLT >         B BRAUN              6%                        N19018 001
> ADD >       @                      500MG                     N13378 001   > DLT >                                                      JUL 20, 1984
                                                                            > ADD >      +                       6%                        N19018 001
                                                                            > ADD >                                                      JUL 20, 1984
          ADAPALENE                                                                       TROPHAMINE 10%
                                                                            > DLT >         B BRAUN              10%                       N19018 003
> ADD >     CREAM; TOPICAL                                                  > DLT >                                                      SEP 07, 1988
> ADD >       DIFFERIN                                                      > ADD >      +                       10%                       N19018 003
> ADD >      +  GALDERMA LABS LP     0.1%                      N20748 001   > ADD >                                                      SEP 07, 1988
> ADD >                                                      MAY 26, 2000

                                                                                      AMRINONE LACTATE
          ALBUTEROL
                                                                                        INJECTABLE; INJECTION
            AEROSOL, METERED; INHALATION                                                  AMRINONE
              ALBUTEROL                                                     > ADD >  AP     BEDFORD              EQ 5MG BASE/ML            N75513 001
> DLT >  AB     MEDISOL              0.09MG/INH                N74072 001   > ADD >                                                      MAY 09, 2000
> DLT >                                                      AUG 01, 1996                 AMRINONE LACTATE
> ADD >  AB     SIDMAK LABS CA       0.09MG/INH                N74072 001   > ADD >  AP     BAXTER PHARM PROD    EQ 5MG BASE/ML            N75542 001
> ADD >                                                      AUG 01, 1996   > ADD >                                                      MAY 10, 2000


                                                                                      ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

                                                                                        TABLET; ORAL
                                                                                          DIPHENOXYLATE HCL AND ATROPINE SULFATE
                                                                            > ADD >  AA     PAR PHARM            0.025MG;2.5MG             N40357 001
                                                                            > ADD >                                                      MAY 02, 2000


 



          AZELASTINE HYDROCHLORIDE                                                    CISPLATIN

> ADD >     SOLUTION/DROPS; OPHTHALMIC                                                  INJECTABLE; INJECTION
> ADD >       OPTIVAR                                                                     CISPLATIN
> ADD >      +  ASTA                 0.05%                     N21127 001   > ADD >  AP     GENSIA SICOR PHARMS  1MG/ML                    N74814 001
> ADD >                                                      MAY 22, 2000   > ADD >                                                      MAY 16, 2000
                                                                            > ADD >  AP     PHARMACHEMIE         1MG/ML                    N74656 001
                                                                            > ADD >                                                      MAY 16, 2000
          BETHANECHOL CHLORIDE

            TABLET; ORAL                                                              CLINDAMYCIN PHOSPHATE
> DLT >       BETHANECHOL CHLORIDE
> DLT >  AA     DANBURY PHARMA       10MG                      N84408 001               SOLUTION; TOPICAL
> DLT >  AA                          25MG                      N84441 001                 CLINDAMYCIN PHOSPHATE
> DLT >  AA                          50MG                      N87444 001   > ADD >  AT     CLAY PARK            EQ 1% BASE                N65049 001
> ADD >       @                      10MG                      N84408 001   > ADD >                                                      MAY 25, 2000
> ADD >       @                      25MG                      N84441 001
> ADD >       @                      50MG                      N87444 001
> DLT >       DUVOID                                                                  CLOBETASOL PROPIONATE
> DLT >  AA     ROBERTS LABS         10MG                      N86262 001
> DLT >  AA                          25MG                      N86263 001   > ADD >     AEROSOL; TOPICAL
> DLT >  AA                          50MG                      N85882 003   > ADD >       OLUX FOAM
> ADD >       @                      10MG                      N86262 001   > ADD >      +  CONNETICS            0.05%                     N21142 001
> ADD >       @                      25MG                      N86263 001   > ADD >                                                      MAY 26, 2000
> ADD >       @                      50MG                      N85882 003
> DLT >       MYOTONACHOL                                                               CREAM; TOPICAL
> DLT >  AA     GLENWOOD             5MG                       N84188 001                 CLOBETASOL PROPIONATE
> DLT >  AA                          10MG                      N84188 003   > ADD >  AB2    TARO                 0.05%                     N75633 001
> DLT >  AA                          25MG                      N84188 004   > ADD >                                                      MAY 17, 2000
> ADD >       @                      5MG                       N84188 001
> ADD >       @                      10MG                      N84188 003
> ADD >       @                      25MG                      N84188 004   > ADD >   COLESEVELAM HYDROCHLORIDE
              URECHOLINE
> ADD >      +  ODYSSEY PHARMS       5MG                       N89095 001   > ADD >     CAPSULE; ORAL
> ADD >                                                      DEC 19, 1985   > ADD >       WELCHOL
> ADD >      +                       10MG                      N88440 001   > ADD >      +  GELTEX               375MG                     N21141 001
> ADD >                                                      MAY 29, 1984   > ADD >                                                      MAY 26, 2000
> ADD >      +                       25MG                      N88441 001
> ADD >                                                      MAY 29, 1984   > ADD >     TABLET; ORAL
> ADD >      +                       50MG                      N89096 001   > ADD >       WELCHOL
> ADD >                                                      DEC 19, 1985   > ADD >      +  GELTEX               625MG                     N21176 001
> DLT >  AA  +  SIDMAK LABS NJ       5MG                       N89095 001   > ADD >                                                      MAY 26, 2000
> DLT >                                                      DEC 19, 1985
> DLT >  AA  +                       10MG                      N88440 001
> DLT >                                                      MAY 29, 1984             CYCLOSPORINE
> DLT >  AA  +                       25MG                      N88441 001
> DLT >                                                      MAY 29, 1984               CAPSULE; ORAL
> DLT >  AA  +                       50MG                      N89096 001                 CYCLOSPORINE
> DLT >                                                      DEC 19, 1985   > ADD >  AB     ABBOTT               25MG                      N65003 001
                                                                            > ADD >                                                      MAY 12, 2000


 



          CYCLOSPORINE                                                      > ADD >   GEMTUZUMAB OZOGAMICIN

            CAPSULE; ORAL                                                   > ADD >     INJECTABLE; INJECTION
              CYCLOSPORINE                                                  > ADD >       MYLOTARG
> ADD >  AB     ABBOTT               50MG                      N65003 002   > ADD >      +  WYETH AYERST         5MG/VIAL                  N21174 001
> ADD                                                        MAY 12, 2000   > ADD >                                                      MAY 17, 2000
> ADD >  AB                          100MG                     N65003 003
> ADD >                                                      MAY 12, 2000
              NEORAL                                                                  HYDROCORTISONE
> ADD >  AB     NOVARTIS             50MG                      N50715 003
> ADD >                                                      JUL 14, 1995               CREAM; TOPICAL
> DLT >  BX                          50MG                      N50715 003                 NUTRACORT
> DLT >                                                      JUL 14, 1995   > DLT >  AT     GALDERMA LABS        0.5%                      N80442 002
                                                                            > DLT >  AT                          1%                        N80442 003
                                                                            > ADD >  AT     HEALTHPOINT          1%                        N80442 003
          ERGOTAMINE TARTRATE                                               > ADD >       @                      0.5%                      N80442 002

            TABLET; SUBLINGUAL                                                          GEL; TOPICAL
              ERGOMAR                                                                     NUTRACORT
> DLT >  AA     LOTUS BIOCHEM        2MG                       N87693 001   > DLT >       @ GALDERMA LABS        1%                        N84698 001
> DLT >                                                      FEB 24, 1983   > ADD >       @ HEALTHPOINT          1%                        N84698 001
> ADD >      +                       2MG                       N87693 001
> ADD >                                                      FEB 24, 1983               LOTION; TOPICAL
> DLT >       ERGOSTAT                                                                    NUTRACORT
> DLT >  AA     PARKE DAVIS          2MG                       N88337 001   > DLT >  AT     GALDERMA LABS        0.5%                      N80443 002
> DLT >                                                      JUN 08, 1984   > DLT >  AT                          1%                        N80443 003
> ADD >       @                      2MG                       N88337 001   > DLT >  AT                          2.5%                      N87644 001
> ADD >                                                      JUN 08, 1984   > DLT >                                                      AUG 24, 1982
> DLT >       WIGRETTES                                                     > ADD >  AT     HEALTHPOINT          1%                        N80443 003
> DLT >  AA  +  ORGANON              2MG                       N86750 001   > ADD >  AT                          2.5%                      N87644 001
> DLT >                                                      JUL 29, 1982   > ADD >                                                      AUG 24, 1982
> ADD >       @                      2MG                       N86750 001   > ADD >       @                      0.5%                      N80443 002
> ADD >                                                      JUL 29, 1982

                                                                                      HYDROCORTISONE BUTYRATE
          ERYTHROMYCIN
                                                                                        CREAM; TOPICAL
            SOLUTION; TOPICAL                                                             LOCOID
              SANSAC                                                        > DLT >       @ GALDERMA LABS        0.1%                      N18795 001
> DLT >  AT     GALDERMA LABS        2%                        N62522 001   > DLT >                                                      JAN 07, 1983
> DLT >                                                      JAN 24, 1985   > ADD >       @ YAMANOUCHI           0.1%                      N18795 001
> ADD >  AT     HEALTHPOINT          2%                        N62522 001   > ADD >                                                      JAN 07, 1983
> ADD >                                                      JAN 24, 1985
                                                                                        OINTMENT; TOPICAL
                                                                                          LOCOID
                                                                            > DLT >       @ GALDERMA LABS        0.1%                      N19106 001
                                                                            > DLT >                                                      JUL 03, 1984
                                                                            > ADD >       @ YAMANOUCHI           0.1%                      N19106 001
                                                                            > ADD >                                                      JUL 03, 1984


 



          HYDROCORTISONE BUTYRATE                                                     METAPROTERENOL SULFATE

            SOLUTION; TOPICAL                                                           SOLUTION; INHALATION
              LOCOID                                                                      ALUPENT
> DLT >       @ GALDERMA LABS        0.1%                      N19819 001   > DLT >  AN  +  BOEHRINGER INGELHEIM 5%                        N17659 001
> DLT >                                                      SEP 15, 1988   > ADD >      +                       5%                        N17659 001
> ADD >       @ YAMANOUCHI           0.1%                      N19819 001   > DLT >       PROMETA
> ADD >                                                      SEP 15, 1988   > DLT >  AN     MURO                 5%                        N73340 001
                                                                            > DLT >                                                      MAR 30, 1992
                                                                            > ADD >       @                      5%                        N73340 001
          HYDROCORTISONE VALERATE                                           > ADD >                                                      MAR 30, 1992

            CREAM; TOPICAL
              HYDROCORTISONE VALERATE                                                 METHYLPHENIDATE HYDROCHLORIDE
> ADD >  AB     CLAY PARK            0.2%                      N75666 001
> ADD >                                                      MAY 24, 2000               TABLET, EXTENDED RELEASE; ORAL
                                                                                          METADATE ER
                                                                            > ADD >  AB  +  MEDEVA               10MG                      N40306 001
          ISOSORBIDE DINITRATE                                              > ADD >                                                      OCT 20, 1999
                                                                            > DLT >      +                       10MG                      N40306 001
            TABLET, EXTENDED RELEASE; ORAL                                  > DLT >                                                      OCT 20, 1999
> DLT >       ISORDIL                                                       > ADD >       METHYLIN ER
> DLT >  AB  +  WYETH AYERST         40MG                      N12882 001   > ADD >  AB     MALLINCKRODT         10MG                      N75629 001
> DLT >                                                      JUL 29, 1988   > ADD >                                                      MAY 09, 2000
> ADD >       @                      40MG                      N12882 001   > ADD >  AB                          20MG                      N75629 002
> ADD >                                                      JUL 29, 1988   > ADD >                                                      MAY 09, 2000
              ISOSORBIDE DINITRATE
> DLT >  AB     INWOOD LABS          40MG                      N40009 001
> DLT >                                                      DEC 30, 1998             METHYLTESTOSTERONE
> ADD >      +                       40MG                      N40009 001
> ADD >                                                      DEC 30, 1998               TABLET; ORAL
                                                                            > DLT >       ORETON METHYL
                                                                            > DLT >  BP     SCHERING             10MG                      N03158 001
          LEVOBUPIVACAINE HYDROCHLORIDE                                     > DLT >  BP                          25MG                      N03158 002
                                                                            > ADD >       @                      10MG                      N03158 001
            INJECTABLE; INJECTION                                           > ADD >       @                      25MG                      N03158 002
              CHIROCAINE
> ADD >         DARWIN DISCOVERY     EQ 2.5MG BASE/ML          N20997 001
> ADD >                                                      AUG 05, 1999             NABUMETONE
> ADD >                              EQ 5MG BASE/ML            N20997 002
> ADD >                                                      AUG 05, 1999               TABLET; ORAL
> ADD >      +                       EQ 7.5MG BASE/ML          N20997 003   > ADD >       NABUMETONE
> ADD >                                                      AUG 05, 1999   > ADD >  AB     TEVA                 500MG                     N75189 001
> DLT >         PURDUE PHARMA        EQ 2.5MG BASE/ML          N20997 001   > ADD >                                                      MAY 26, 2000
> DLT >                                                      AUG 05, 1999                 RELAFEN
> DLT >                              EQ 5MG BASE/ML            N20997 002   > ADD >  AB     SMITHKLINE BEECHAM   500MG                     N19583 001
> DLT >                                                      AUG 05, 1999   > ADD >                                                      DEC 24, 1991
> DLT >      +                       EQ 7.5MG BASE/ML          N20997 003   > DLT >                              500MG                     N19583 001
> DLT >                                                      AUG 05, 1999   > DLT >                                                      DEC 24, 1991


 

          NAFCILLIN SODIUM                                                            PENTAMIDINE ISETHIONATE

> DLT >     TABLET; ORAL                                                                INJECTABLE; INJECTION
> DLT >       UNIPEN                                                        > DLT >       PENTACARINAT
> DLT >      +  WYETH AYERST         EQ 500MG BASE             N50462 001   > DLT >  AP     ARMOUR PHARM         300MG/VIAL                N73447 001
> ADD >       @                      EQ 500MG BASE             N50462 001   > DLT >                                                      APR 28, 1994
                                                                            > ADD >       @                      300MG/VIAL                N73447 001
                                                                            > ADD >                                                      APR 28, 1994
          NIACIN

            TABLET; ORAL                                                              PREDNISONE
> ADD >       NIACOR
> ADD >  AA     UPSHER SMITH         500MG                     N40378 001   > DLT >     SYRUP; ORAL
> ADD >                                                      MAY 03, 2000   > DLT >       LIQUID PRED
                                                                            > DLT >      +  MURO                 5MG/5ML                   N87611 002
                                                                            > DLT >                                                      SEP 07, 1982
          NITROFURAZONE                                                     > ADD >       @                      5MG/5ML                   N87611 002
                                                                            > ADD >                                                      SEP 07, 1982
            CREAM; TOPICAL
              FURACIN                                                                   TABLET; ORAL
> DLT >      +  ROBERTS LABS         0.2%                      N83789 001   > DLT >       PREDNICEN-M
> ADD >      +  SHIRE LABS           0.2%                      N83789 001   > DLT >  AB     CENT PHARMS          5MG                       N84655 001
                                                                            > ADD >       @ SCHWARZ PHARMA       5MG                       N84655 001

          NITROGLYCERIN
                                                                                      SOTALOL HYDROCHLORIDE
> ADD >     TABLET; SUBLINGUAL
> ADD >       NITROSTAT                                                                 TABLET; ORAL
> ADD >         PARKE DAVIS          0.3MG                     N21134 001                 BETAPACE
> ADD >                                                      MAY 01, 2000   > ADD >  AB     BERLEX LABS          80MG                      N19865 001
> ADD >                              0.4MG                     N21134 002   > ADD >                                                      OCT 30, 1992
> ADD >                                                      MAY 01, 2000   > ADD >  AB                          120MG                     N19865 005
> ADD >      +                       0.6MG                     N21134 003   > ADD >                                                      APR 20, 1994
> ADD >                                                      MAY 01, 2000   > ADD >  AB  +                       160MG                     N19865 002
                                                                            > ADD >                                                      OCT 30, 1992
                                                                            > ADD >  AB                          240MG                     N19865 003
          NORTRIPTYLINE HYDROCHLORIDE                                       > ADD >                                                      OCT 30, 1992
                                                                            > DLT >                              80MG                      N19865 001
            CAPSULE; ORAL                                                   > DLT >                                                      OCT 30, 1992
              NORTRIPTYLINE HCL                                             > DLT >                              120MG                     N19865 005
> ADD >  AB     TARO                 EQ 10MG BASE              N75520 004   > DLT >                                                      APR 20, 1994
> ADD >                                                      MAY 08, 2000   > DLT >      +                       160MG                     N19865 002
> ADD >  AB                          EQ 25MG BASE              N75520 003   > DLT >                                                      OCT 30, 1992
> ADD >                                                      MAY 08, 2000   > DLT >                              240MG                     N19865 003
> ADD >  AB                          EQ 50MG BASE              N75520 001   > DLT >                                                      OCT 30, 1992
> ADD >                                                      MAY 08, 2000   > ADD >       SOTALOL HCL
> ADD >  AB                          EQ 75MG BASE              N75520 002   > ADD >  AB     EON                  80MG                      N75366 001
> ADD >                                                      MAY 08, 2000   > ADD >                                                      MAY 01, 2000


 



          SOTALOL HYDROCHLORIDE                                                       THIAMINE HYDROCHLORIDE

            TABLET; ORAL                                                                INJECTABLE; INJECTION
> ADD >       SOTALOL HCL                                                                 BETALIN S
> ADD >  AB     EON                  120MG                     N75366 002   > DLT >  AP  +  LILLY                100MG/ML                  N80853 001
> ADD                                                        MAY 01, 2000   > ADD >       @                      100MG/ML                  N80853 001
> ADD >  AB                          160MG                     N75366 003                 THIAMINE HCL
> ADD >                                                      MAY 01, 2000   > DLT >  AP     AM PHARM PARTNERS    100MG/ML                  N80556 001
> ADD >  AB                          240MG                     N75366 004   > ADD >  AP  +                       100MG/ML                  N80556 001
> ADD >                                                      MAY 01, 2000
> ADD >  AB     GENPHARM             80MG                      N75237 001
> ADD >                                                      MAY 01, 2000             URSODIOL
> ADD >  AB                          120MG                     N75237 002
> ADD >                                                      MAY 01, 2000               CAPSULE; ORAL
> ADD >  AB                          160MG                     N75237 003                 URSODIOL
> ADD >                                                      MAY 01, 2000   > ADD >  AB     COPLEY PHARM         300MG                     N75592 001
> ADD >  AB                          240MG                     N75237 004   > ADD >                                                      MAY 25, 2000
> ADD >                                                      MAY 01, 2000
> ADD >  AB     TEVA                 80MG                      N75429 001
> ADD >                                                      MAY 01, 2000
> ADD >  AB                          120MG                     N75429 002
> ADD >                                                      MAY 01, 2000
> ADD >  AB                          160MG                     N75429 003
> ADD >                                                      MAY 01, 2000
> ADD >  AB                          240MG                     N75429 004
> ADD >                                                      MAY 01, 2000


          TAMOXIFEN CITRATE

            TABLET; ORAL
> ADD >       TAMOXIFEN CITRATE
> ADD >       @ PHARMACHEMIE         EQ 10MG BASE              N74539 001
> ADD >                                                      MAY 31, 2000


          TERAZOSIN HYDROCHLORIDE

            TABLET; ORAL
              TERAZOSIN HCL
> ADD >  AB     NOVOPHARM            EQ 1MG BASE               N74446 001
> ADD >                                                      MAY 18, 2000
> ADD >  AB                          EQ 2MG BASE               N74446 002
> ADD >                                                      MAY 18, 2000
> ADD >  AB                          EQ 5MG BASE               N74446 003
> ADD >                                                      MAY 18, 2000
> ADD >  AB                          EQ 10MG BASE              N74446 004
> ADD >                                                      

ADDITIONS/DELETIONS FOR OTC DRUG PRODUCT LIST





 

          RANITIDINE HYDROCHLORIDE

            TABLET; ORAL
              RANITIDINE
> ADD >         TORPHARM             EQ 75MG BASE              N75167 001
> ADD >                                                      MAY 04, 2000



 
Last update: July 15, 2005
horizonal rule