[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 
25th Edition
Cumulative Supplement Number 5: May 2006


[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

        ACEBUTOLOL HYDROCHLORIDE
          CAPSULE; ORAL
            SECTRAL
>A>   AB      DR REDDYS LABS INC         EQ 200MG BASE                           N18917 001  Dec 28, 1984    May  CAHN
>A>   AB  +                              EQ 400MG BASE                           N18917 003  Dec 28, 1984    May  CAHN
>D>   AB      ESP PHARMA                 EQ 200MG BASE                           N18917 001  Dec 28, 1984    May  CAHN
>D>   AB  +                              EQ 400MG BASE                           N18917 003  Dec 28, 1984    May  CAHN

        ACETAMINOPHEN; HYDROCODONE BITARTRATE
          TABLET; ORAL
>D>         HYDROCODONE BITARTRATE AND ACETAMINOPHEN
>D>       +   ENDO PHARMS                400MG;5MG                               N40288 001  Nov 27, 1998    May  CTNA
>D>       +                              400MG;7.5MG                             N40288 002  Nov 27, 1998    May  CTNA
>D>       +                              400MG;10MG                              N40288 003  Nov 27, 1998    May  CTNA
>A>         ZYDONE
>A>       +   ENDO PHARMS                400MG;5MG                               N40288 001  Nov 27, 1998    May  CTNA
>A>       +                              400MG;7.5MG                             N40288 002  Nov 27, 1998    May  CTNA
>A>       +                              400MG;10MG                              N40288 003  Nov 27, 1998    May  CTNA

        ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
          TABLET; ORAL
            OXYCODONE AND ACETAMINOPHEN
>A>       +   MIKART                     400MG;2.5MG                             N40679 001  May 16, 2006    May  NEWA

        ACYCLOVIR
          CAPSULE; ORAL
            ACYCLOVIR
>D>   AB      AAIPHARMA LLC              200MG                                   N74833 001  Apr 22, 1997    May  CAHN
>A>   AB      CLONMEL HLTHCARE           200MG                                   N74833 001  Apr 22, 1997    May  CAHN
          TABLET; ORAL
            ACYCLOVIR
>D>   AB      AAIPHARMA LLC              400MG                                   N74946 001  Nov 19, 1997    May  CAHN
>D>   AB                                 800MG                                   N74946 002  Nov 19, 1997    May  CAHN
>A>   AB      CLONMEL HLTHCARE           400MG                                   N74946 001  Nov 19, 1997    May  CAHN
>A>   AB                                 800MG                                   N74946 002  Nov 19, 1997    May  CAHN

        AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE;
          TABLET; ORAL
            DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
>D>   AB      ABRIKA PHARMS              1.25MG;1.25MG;1.25MG;1.25MG             N40472 001  Sep 30, 2003    May  CAHN
>D>   AB                                 2.5MG;2.5MG;2.5MG;2.5MG                 N40472 002  Sep 30, 2003    May  CAHN
>D>   AB                                 5MG;5MG;5MG;5MG                         N40472 003  Sep 30, 2003    May  CAHN
>D>   AB                                 7.5MG;7.5MG;7.5MG;7.5MG                 N40472 004  Sep 30, 2003    May  CAHN
>A>   AB      TEVA PHARMS                1.25MG;1.25MG;1.25MG;1.25MG             N40472 001  Sep 30, 2003    May  CAHN
>A>   AB                                 2.5MG;2.5MG;2.5MG;2.5MG                 N40472 002  Sep 30, 2003    May  CAHN
>A>   AB                                 5MG;5MG;5MG;5MG                         N40472 003  Sep 30, 2003    May  CAHN
>A>   AB                                 7.5MG;7.5MG;7.5MG;7.5MG                 N40472 004  Sep 30, 2003    May  CAHN

        ATOVAQUONE
>D>       TABLET; ORAL
>D>         MEPRON
>D>       +   GLAXOSMITHKLINE            250MG                                   N20259 001  Nov 25, 1992    May  DISC
>A>         @                            250MG                                   N20259 001  Nov 25, 1992    May  DISC

        BRIMONIDINE TARTRATE
          SOLUTION/DROPS; OPHTHALMIC
            ALPHAGAN P
>D>       +   ALLERGAN                   0.15%                                   N21262 001  Mar 16, 2001    May  CTEC
>A>   AT  +                              0.15%                                   N21262 001  Mar 16, 2001    May  CTEC
            BRIMONIDINE TARTRATE
>A>   AT      ALCON RES                  0.15%                                   N21764 001  May 22, 2006    May  NEWA

        CANDESARTAN CILEXETIL
          TABLET; ORAL
            ATACAND
>D>       +   ASTRAZENECA                8MG                                     N20838 002  Jun 04, 1998    May  CRLD
>A>                                      8MG                                     N20838 002  Jun 04, 1998    May  CRLD

        CASPOFUNGIN ACETATE
          INJECTABLE; IV (INFUSION)
            CANCIDAS
>A>       +   MERCK                      50MG/VIAL                               N21227 001  Jan 26, 2001    May  CAHN
>A>       +                              70MG/VIAL                               N21227 002  Jan 26, 2001    May  CAHN
>D>       +   MERCK RES                  50MG/VIAL                               N21227 001  Jan 26, 2001    May  CAHN
>D>       +                              70MG/VIAL                               N21227 002  Jan 26, 2001    May  CAHN

        CEFACLOR
          TABLET, EXTENDED RELEASE; ORAL
            CEFACLOR
>D>   AB  +   IVAX PHARMS                EQ 500MG BASE                           N65057 001  Jan 05, 2001    May  CAHN
>A>   AB  +   PAR PHARM                  EQ 500MG BASE                           N65057 001  Jan 05, 2001    May  CAHN

        CEFAZOLIN SODIUM
          INJECTABLE; INJECTION
            CEFAZOLIN AND DEXTROSE
>D>       +   B BRAUN                    EQ 500MG BASE/VIAL                      N50779 001  Jul 27, 2000    May  DISC
>A>         @                            EQ 500MG BASE/VIAL                      N50779 001  Jul 27, 2000    May  DISC

        CEFDINIR
          CAPSULE; ORAL
>A>         CEFDINIR
>A>   AB      LUPIN                      300MG                                   N65264 001  May 19, 2006    May  NEWA
            OMNICEF
>D>       +   ABBOTT                     300MG                                   N50739 001  Dec 04, 1997    May  CFTG
>A>   AB  +                              300MG                                   N50739 001  Dec 04, 1997    May  CFTG
          FOR SUSPENSION; ORAL
>A>         CEFDINIR
>A>   AB      LUPIN (USA)                125MG/5ML                               N65259 001  May 31, 2006    May  NEWA
            OMNICEF
>D>           ABBOTT                     125MG/5ML                               N50749 001  Dec 04, 1997    May  CFTG
>A>   AB                                 125MG/5ML                               N50749 001  Dec 04, 1997    May  CFTG

        CEFOTAXIME SODIUM
          INJECTABLE; INJECTION
>D>         CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
>D>       +   B BRAUN                    EQ 2GM BASE                             N50792 001  Jul 29, 2004    May  DISC
>A>         @                            EQ 2GM BASE                             N50792 001  Jul 29, 2004    May  DISC
>D>         CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
>D>       +   B BRAUN                    EQ 1GM BASE                             N50792 002  Jul 29, 2004    May  DISC
>A>         @                            EQ 1GM BASE                             N50792 002  Jul 29, 2004    May  DISC


>D>     CEFTAZIDIME (ARGININE FORMULATION)
>D>       INJECTABLE; INJECTION
>D>         CEPTAZ
>D>       +   GLAXOSMITHKLINE            1GM/VIAL                                N50646 002  Sep 27, 1990    May  DISC
>A>         @                            1GM/VIAL                                N50646 002  Sep 27, 1990    May  DISC
>D>       +                              2GM/VIAL                                N50646 003  Sep 27, 1990    May  DISC
>A>         @                            2GM/VIAL                                N50646 003  Sep 27, 1990    May  DISC
>D>       +                              10GM/VIAL                               N50646 004  Sep 27, 1990    May  DISC
>A>         @                            10GM/VIAL                               N50646 004  Sep 27, 1990    May  DISC

        CEFTRIAXONE SODIUM
          INJECTABLE; INJECTION
            CEFTRIAXONE
>A>   AP      WOCKHARDT                  EQ 1GM BASE/VIAL                        N65180 001  May 12, 2006    May  NEWA

        CEPHALEXIN
          CAPSULE; ORAL
            KEFLEX
>A>           ADVANCIS PHARM             EQ 333MG BASE                           N50405 004  May 12, 2006    May  NEWA
>D>   AB  +                              EQ 500MG BASE                           N50405 003                  May  CRLD
>A>   AB                                 EQ 500MG BASE                           N50405 003                  May  CRLD
>A>       +                              EQ 750MG BASE                           N50405 005  May 12, 2006    May  NEWA


>D>     CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL
>D>       FOR SUSPENSION; INTRATRACHEAL
>D>         EXOSURF NEONATAL
>D>       +   GLAXOSMITHKLINE            12MG/VIAL;108MG/VIAL;8MG/VIAL           N20044 001  Aug 02, 1990    May  DISC
>A>         @                            12MG/VIAL;108MG/VIAL;8MG/VIAL           N20044 001  Aug 02, 1990    May  DISC


>D>     CHLORPROMAZINE
>D>       SUPPOSITORY; RECTAL
>D>         THORAZINE
>D>       +   GLAXOSMITHKLINE            25MG                                    N09149 024                  May  DISC
>A>         @                            25MG                                    N09149 024                  May  DISC
>D>       +                              100MG                                   N09149 033                  May  DISC
>A>         @                            100MG                                   N09149 033                  May  DISC

        CHLORPROMAZINE HYDROCHLORIDE
>D>       CAPSULE, EXTENDED RELEASE; ORAL
>D>         THORAZINE
>D>       +   GLAXOSMITHKLINE            200MG                                   N11120 019                  May  DISC
>A>         @                            200MG                                   N11120 019                  May  DISC
>D>       +                              300MG                                   N11120 020                  May  DISC
>A>         @                            300MG                                   N11120 020                  May  DISC


        CITALOPRAM HYDROBROMIDE
          SOLUTION; ORAL
            CITALOPRAM HYDROBROMIDE
>A>   AA      SILARX                     EQ 10MG BASE/5ML                        N77629 001  Jun 15, 2006    May  NEWA

        CLARITHROMYCIN
          TABLET; ORAL
            CLARITHROMYCIN
>A>   AB      WOCKHARDT                  250MG                                   N65266 001  May 31, 2006    May  NEWA
>A>   AB                                 500MG                                   N65266 002  May 31, 2006    May  NEWA

        CLOBETASOL PROPIONATE
          SOLUTION; TOPICAL
            CLOBETASOL PROPIONATE
>D>   AT      ALTANA                     0.05%                                   N75391 001  Feb 08, 1999    May  DISC
>A>         @                            0.05%                                   N75391 001  Feb 08, 1999    May  DISC


        CROMOLYN SODIUM
>A>       CONCENTRATE; ORAL
>A>         GASTROCROM
>A>       +   AZUR PHARMA                100MG/5ML                               N20479 001  Feb 29, 1996    May  CDFR
>D>       SOLUTION, CONCENTRATE; ORAL
>D>         GASTROCROM
>D>       +   AZUR PHARMA                100MG/5ML                               N20479 001  Feb 29, 1996    May  CDFR

        CYPROHEPTADINE HYDROCHLORIDE
          TABLET; ORAL
            CYPROHEPTADINE HYDROCHLORIDE
>D>         @ ABC HOLDING                4MG                                     N88212 001  May 26, 1983    May  CAHN
>A>         @ TG UNITED LABS             4MG                                     N88212 001  May 26, 1983    May  CAHN
            CYPROHEPTADINE HYDROCLORIDE
>A>   AA      STASON PHARMS              4MG                                     N40644 001  May 30, 2006    May  NEWA

>A>     DECITABINE
>A>       INJECTABLE; INTRAVENOUS
>A>         DACOGEN
>A>       +   MGI PHARMA INC             50MG/VIAL                               N21790 001  May 02, 2006    May  NEWA


        DICLOFENAC SODIUM
          TABLET, DELAYED RELEASE; ORAL
            DICLOFENAC SODIUM
>D>   AB  +   SANDOZ                     75MG                                    N74394 001  Nov 30, 1995    May  CRLD
>A>   AB                                 75MG                                    N74394 001  Nov 30, 1995    May  CRLD
            VOLTAREN
>D>         @ NOVARTIS                   75MG                                    N19201 003  Jul 28, 1988    May  CMFD
>A>   AB  +                              75MG                                    N19201 003  Jul 28, 1988    May  CMFD

        DIETHYLPROPION HYDROCHLORIDE
          TABLET; ORAL
            DIETHYLPROPION HYDROCHLORIDE
>D>         @ ABC HOLDING                25MG                                    N88268 001  Aug 25, 1983    May  CAHN
>D>         @                            25MG                                    N88267 001  Aug 25, 1983    May  CAHN
>A>         @ TG UNITED LABS             25MG                                    N88268 001  Aug 25, 1983    May  CAHN
>A>         @                            25MG                                    N88267 001  Aug 25, 1983    May  CAHN


        DOXYCYCLINE
>A>       CAPSULE, DELAYED RELEASE; ORAL
>A>         ORACEA
>A>       +   COLLAGENEX PHARMS          40MG                                    N50805 001  May 26, 2006    May  NEWA
          TABLET; ORAL
            DOXYCYCLINE
>D>           PAR PHARM                  EQ 75MG BASE                            N65070 003  Dec 30, 2002    May  CFTG
>A>   AB                                 EQ 75MG BASE                            N65070 003  Dec 30, 2002    May  CFTG
>A>   AB      RANBAXY                    EQ 50MG BASE                            N65356 001  May 31, 2006    May  NEWA
>A>   AB                                 EQ 75MG BASE                            N65356 002  May 31, 2006    May  NEWA
>A>   AB                                 EQ 100MG BASE                           N65356 003  May 31, 2006    May  NEWA

        EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
>D>       PATCH; IONTOPHORESIS
>D>         LIDOSITE TOPICAL SYSTEM KIT
>D>       +   VYTERIS                    1.05MG/PATCH;100MG/PATCH                N21504 001  May 06, 2004    May  CDFR
>A>       PATCH; IONTOPHORESIS, TOPICAL
>A>         LIDOSITE TOPICAL SYSTEM KIT
>A>       +   VYTERIS                    1.05MG/PATCH;100MG/PATCH                N21504 001  May 06, 2004    May  CDFR
>D>       SOLUTION; IONTOPHORESIS
>D>         LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
>D>       +   EMPI                       0.01MG/ML;2%                            N21486 001  Oct 26, 2004    May  CDFR
>A>       SOLUTION; IONTOPHORESIS, TOPICAL
>A>         LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
>A>       +   EMPI                       0.01MG/ML;2%                            N21486 001  Oct 26, 2004    May  CDFR


        ESCITALOPRAM OXALATE
          TABLET; ORAL
>A>         ESCITALOPRAM OXALATE
>A>   AB      IVAX PHARMS                5MG                                     N76765 001  May 22, 2006    May  NEWA
>A>   AB                                 10MG                                    N76765 002  May 22, 2006    May  NEWA
>A>   AB                                 20MG                                    N76765 003  May 22, 2006    May  NEWA
            LEXAPRO
>D>           FOREST LABS                5MG                                     N21323 001  Aug 14, 2002    May  CFTG
>A>   AB                                 5MG                                     N21323 001  Aug 14, 2002    May  CFTG
>D>                                      10MG                                    N21323 002  Aug 14, 2002    May  CFTG
>A>   AB                                 10MG                                    N21323 002  Aug 14, 2002    May  CFTG
>D>       +                              20MG                                    N21323 003  Aug 14, 2002    May  CFTG
>A>   AB  +                              20MG                                    N21323 003  Aug 14, 2002    May  CFTG

        ETHINYL ESTRADIOL; LEVONORGESTREL
>A>       TABLET; ORAL
>A>         SEASONIQUE
>A>       +   DURAMED RES                0.03MG,0.01MG;0.15MG,N/A                N21840 001  May 25, 2006    May  NEWA
          TABLET; ORAL-28
            LEVONORGESTREL AND ETHINYL ESTRADIOL
>A>   AB2     WATSON LABS                0.02MG;0.1MG                            N77681 001  May 31, 2006    May  NEWA

        FENTANYL HYDROCHLORIDE
>A>       SYSTEM; IONTOPHORESIS, TRANSDERMAL
>A>         IONSYS                          .
>A>       +   ALZA                       10.8UGM                                 N21338 001  May 22, 2006    May  NEWA


        FLUORESCEIN SODIUM
          INJECTABLE; INTRAVENOUS
            FLUORESCITE
>A>       +   ALCON                      EQ 500MG BASE/5ML (EQ 100MG             N21980 001  Mar 28, 2006    May  CAHN
>D>       +   ALCON RES                  EQ 500MG BASE/5ML (EQ 100MG             N21980 001  Mar 28, 2006    May  CAHN

        FLUOXETINE HYDROCHLORIDE
          TABLET; ORAL
>A>         SARAFEM
>A>           WARNER CHILCOTT            EQ 10MG BASE                            N21860 001  May 19, 2006    May  NEWA
>A>                                      EQ 15MG BASE                            N21860 002  May 19, 2006    May  NEWA
>A>       +                              EQ 20MG BASE                            N21860 003  May 19, 2006    May  NEWA

        FLUTAMIDE
          CAPSULE; ORAL
>D>         EULEXIN
>D>   AB  +   SCHERING                   125MG                                   N18554 001  Jan 27, 1989    May  DISC
>A>         @                            125MG                                   N18554 001  Jan 27, 1989    May  DISC
            FLUTAMIDE
>D>   AB      SANDOZ                     125MG                                   N75818 001  Sep 18, 2001    May  CRLD
>A>   AB  +                              125MG                                   N75818 001  Sep 18, 2001    May  CRLD


        GALANTAMINE HYDROBROMIDE
          CAPSULE, EXTENDED RELEASE; ORAL
            RAZADYNE ER
>D>       +   JANSSEN                    EQ 8MG BASE                             N21615 001  Dec 22, 2004    May  CMS2
>A>       +                              EQ 8MG BASE                             N21615 001  Apr 01, 2005    May  CMS2
>D>                                      EQ 16MG BASE                            N21615 002  Dec 22, 2004    May  CMS2
>A>                                      EQ 16MG BASE                            N21615 002  Apr 01, 2005    May  CMS2
>D>                                      EQ 24MG BASE                            N21615 003  Dec 22, 2004    May  CMS2
>A>                                      EQ 24MG BASE                            N21615 003  Apr 01, 2005    May  CMS2

        GATIFLOXACIN
>D>       INJECTABLE; INJECTION
>D>         TEQUIN
>D>       +   BRISTOL MYERS              400MG/40ML(10MG/ML)                     N21062 004  Dec 17, 1999    May  DISC
>A>         @                            400MG/40ML(10MG/ML)                     N21062 004  Dec 17, 1999    May  DISC
>D>         TEQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
>D>       +   BRISTOL MYERS              200MG/100ML(2MG/ML)                     N21062 001  Dec 17, 1999    May  DISC
>A>         @                            200MG/100ML(2MG/ML)                     N21062 001  Dec 17, 1999    May  DISC
>D>       +                              400MG/200ML(2MG/ML)                     N21062 002  Dec 17, 1999    May  DISC
>A>         @                            400MG/200ML(2MG/ML)                     N21062 002  Dec 17, 1999    May  DISC
>D>       TABLET; ORAL
>D>         TEQUIN
>D>           BRISTOL MYERS              200MG                                   N21061 001  Dec 17, 1999    May  DISC
>A>         @                            200MG                                   N21061 001  Dec 17, 1999    May  DISC
>D>       +                              400MG                                   N21061 002  Dec 17, 1999    May  DISC
>A>         @                            400MG                                   N21061 002  Dec 17, 1999    May  DISC


        GUANFACINE HYDROCHLORIDE
          TABLET; ORAL
            TENEX
>A>   AB      DR REDDYS LABS INC         EQ 1MG BASE                             N19032 001  Oct 27, 1986    May  CAHN
>A>   AB  +                              EQ 2MG BASE                             N19032 002  Nov 07, 1988    May  CAHN
>A>         @                            EQ 3MG BASE                             N19032 003  Nov 07, 1988    May  CAHN
>D>   AB      ESP PHARMA                 EQ 1MG BASE                             N19032 001  Oct 27, 1986    May  CAHN
>D>   AB  +                              EQ 2MG BASE                             N19032 002  Nov 07, 1988    May  CAHN
>D>         @                            EQ 3MG BASE                             N19032 003  Nov 07, 1988    May  CAHN

        HYDRALAZINE HYDROCHLORIDE
          TABLET; ORAL
            HYDRALAZINE HYDROCHLORIDE
>D>         @ ABC HOLDING                10MG                                    N88846 001  Feb 26, 1985    May  CAHN
>D>         @                            25MG                                    N88847 001  Feb 26, 1985    May  CAHN
>D>         @                            50MG                                    N88848 001  Feb 26, 1985    May  CAHN
>D>         @                            100MG                                   N88849 001  Feb 26, 1985    May  CAHN
>A>         @ TG UNITED LABS             10MG                                    N88846 001  Feb 26, 1985    May  CAHN
>A>         @                            25MG                                    N88847 001  Feb 26, 1985    May  CAHN
>A>         @                            50MG                                    N88848 001  Feb 26, 1985    May  CAHN
>A>         @                            100MG                                   N88849 001  Feb 26, 1985    May  CAHN

        HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
          TABLET; ORAL
            CAM-AP-ES
>D>         @ ABC HOLDING                25MG;15MG;0.1MG                         N84897 001                  May  CAHN
>A>         @ TG UNITED LABS             25MG;15MG;0.1MG                         N84897 001                  May  CAHN


        HYDROCHLOROTHIAZIDE
          TABLET; ORAL
            HYDROCHLOROTHIAZIDE
>D>         @ ABC HOLDING                25MG                                    N85683 001                  May  CAHN
>D>         @                            50MG                                    N83965 001                  May  CAHN
>A>         @ TG UNITED LABS             25MG                                    N85683 001                  May  CAHN
>A>         @                            50MG                                    N83965 001                  May  CAHN


        IPRATROPIUM BROMIDE
          AEROSOL, METERED; INHALATION
>D>         ATROVENT
>D>       +   BOEHRINGER                 0.018MG/INH                             N19085 001  Dec 29, 1986    May  DISC
>A>         @                            0.018MG/INH                             N19085 001  Dec 29, 1986    May  DISC
          SOLUTION; INHALATION
>D>         ATROVENT
>D>   AN  +   BOEHRINGER                 0.02%                                   N20228 001  Sep 29, 1993    May  DISC
>A>         @                            0.02%                                   N20228 001  Sep 29, 1993    May  DISC
            IPRATROPIUM BROMIDE
>D>   AN      DEY                        0.02%                                   N74755 001  Jan 10, 1997    May  CRLD
>A>   AN  +                              0.02%                                   N74755 001  Jan 10, 1997    May  CRLD
>D>   AN      ROXANE                     0.02%                                   N75867 001  Jul 22, 2002    May  DISC
>A>         @                            0.02%                                   N75867 001  Jul 22, 2002    May  DISC

        ISOSORBIDE MONONITRATE
          TABLET; ORAL
            ISMO
>A>   AB      DR REDDYS LABS INC         20MG                                    N19091 001  Dec 30, 1991    May  CAHN
>D>   AB      ESP PHARMA                 20MG                                    N19091 001  Dec 30, 1991    May  CAHN


        ISOTRETINOIN
          CAPSULE; ORAL
            CLARAVIS
>A>   AB      BARR                       30MG                                    N76135 003  May 11, 2006    May  NEWA
            SOTRET
>D>           RANBAXY                    30MG                                    N76503 001  Jun 20, 2003    May  CTEC
>A>   AB                                 30MG                                    N76503 001  Jun 20, 2003    May  CTEC

        ISRADIPINE
          CAPSULE; ORAL
>D>         DYNACIRC
>D>   AB  +   RELIANT PHARMS             2.5MG                                   N19546 001  Dec 20, 1990    May  DISC
>A>         @                            2.5MG                                   N19546 001  Dec 20, 1990    May  DISC

>D>     LEVOCABASTINE HYDROCHLORIDE
>D>       SUSPENSION/DROPS; OPHTHALMIC
>D>         LIVOSTIN
>D>       +   NOVARTIS                   EQ 0.05% BASE                           N20219 001  Nov 10, 1993    May  DISC
>A>         @                            EQ 0.05% BASE                           N20219 001  Nov 10, 1993    May  DISC

        MESALAMINE
          SUPPOSITORY; RECTAL
            CANASA
>D>           AXCAN                      500MG                                   N21252 001  Jan 05, 2001    May  DISC
>A>         @                            500MG                                   N21252 001  Jan 05, 2001    May  DISC

        METFORMIN HYDROCHLORIDE
          TABLET; ORAL
            METFORMIN HYDROCHLORIDE
>A>   AB      INTERPHARM                 500MG                                   N77880 001  Jun 05, 2006    May  NEWA
>A>   AB                                 850MG                                   N77880 002  Jun 05, 2006    May  NEWA
>A>   AB                                 1GM                                     N77880 003  Jun 05, 2006    May  NEWA

        METHIMAZOLE
          TABLET; ORAL
            METHIMAZOLE
>D>           CEDAR PHARMS               20MG                                    N40547 004  Feb 18, 2005    May  CRLD
>A>       +                              20MG                                    N40547 004  Feb 18, 2005    May  CRLD
>D>   AB      JONES PHARMA               5MG                                     N40320 001  Mar 31, 2000    May  CTNA
>D>   AB                                 10MG                                    N40320 002  Mar 31, 2000    May  CTNA
>A>         TAPAZOLE
>A>   AB      JONES PHARMA               5MG                                     N40320 001  Mar 31, 2000    May  CTNA
>A>   AB                                 10MG                                    N40320 002  Mar 31, 2000    May  CTNA

        METOCLOPRAMIDE HYDROCHLORIDE
          TABLET, ORALLY DISINTEGRATING; ORAL
>D>         REGLAN ODT
>D>           SCHWARZ PHARMA             EQ 5MG BASE                             N21793 001  Jun 10, 2005    May  DISC
>A>         @                            EQ 5MG BASE                             N21793 001  Jun 10, 2005    May  DISC
>D>       +                              EQ 10MG BASE                            N21793 002  Jun 10, 2005    May  DISC
>A>         @                            EQ 10MG BASE                            N21793 002  Jun 10, 2005    May  DISC

        METRONIDAZOLE
          GEL; TOPICAL
            METROGEL
>D>       +   GALDERMA LABS LP           0.75%                                   N19737 001  Nov 22, 1988    May  CFTG
>A>   AB  +                              0.75%                                   N19737 001  Nov 22, 1988    May  CFTG
>A>         METRONIDAZOLE
>A>   AB      ALTANA                     0.75%                                   N77018 001  Jun 06, 2006    May  NEWA
          LOTION; TOPICAL
            METROLOTION
>D>       +   GALDERMA LABS LP           0.75%                                   N20901 001  Nov 24, 1998    May  CFTG
>A>   AB  +                              0.75%                                   N20901 001  Nov 24, 1998    May  CFTG
            METRONIDAZOLE
>A>   AB      ALTANA                     0.75%                                   N77197 001  May 24, 2006    May  NEWA

        MINOCYCLINE HYDROCHLORIDE
>A>       TABLET, EXTENDED RELEASE; ORAL
>A>         SOLODYN
>A>           MEDICIS                    EQ 45MG BASE                            N50808 001  May 08, 2006    May  NEWA
>A>                                      EQ 90MG BASE                            N50808 002  May 08, 2006    May  NEWA
>A>       +                              EQ 135MG BASE                           N50808 003  May 08, 2006    May  NEWA

        MOMETASONE FUROATE
          CREAM; TOPICAL
            MOMETASONE FUROATE
>A>   AB      G AND W LABS               0.1%                                    N77447 001  May 22, 2006    May  NEWA

        NABILONE
          CAPSULE; ORAL
            CESAMET
>D>         @ VALEANT                    1MG                                     N18677 001  Dec 26, 1985    May  CMFD
>A>       +                              1MG                                     N18677 001  Dec 26, 1985    May  CMFD

        NOREPINEPHRINE BITARTRATE
          INJECTABLE; INJECTION
            NOREPINEPHRINE BITARTRATE
>A>   AP      METRICS PHARM              EQ 1MG BASE/ML                          N40522 001  Sep 30, 2004    May  CAHN
>D>   AP      PHARMAFORCE                EQ 1MG BASE/ML                          N40522 001  Sep 30, 2004    May  CAHN

        NYSTATIN
          CREAM; TOPICAL
            NYSTATIN
>D>   AT      TARO                       100,000 UNITS/GM                        N62457 001  Jul 28, 1983    May  DISC
>A>         @                            100,000 UNITS/GM                        N62457 001  Jul 28, 1983    May  DISC
>A>   AT      VINTAGE                    100,000 UNITS/GM                        N65315 001  May 31, 2006    May  NEWA
          SUSPENSION; ORAL
            NYSTATIN
>D>         @ TARO                       100,000 UNITS/ML                        N62876 001  Feb 29, 1988    May  CMFD
>A>   AA                                 100,000 UNITS/ML                        N62876 001  Feb 29, 1988    May  CMFD

        ORPHENADRINE CITRATE
          INJECTABLE; INJECTION
            ORPHENADRINE CITRATE
>A>   AP      AKORN                      30MG/ML                                 N40484 001  May 24, 2006    May  NEWA

        PEGAPTANIB SODIUM
          INJECTABLE; INTRAVITREAL
            MACUGEN
>D>       +   EYETECH PHARMS             EQ 0.3MG ACID/0.09ML                    N21756 001  Dec 17, 2004    May  CAHN
>A>       +   OSI EYETECH                EQ 0.3MG ACID/0.09ML                    N21756 001  Dec 17, 2004    May  CAHN

        PHENDIMETRAZINE TARTRATE
          TABLET; ORAL
            CAM-METRAZINE
>D>         @ ABC HOLDING                35MG                                    N85321 001                  May  CAHN
>D>         @                            35MG                                    N85320 001                  May  CAHN
>D>         @                            35MG                                    N85318 001                  May  CAHN
>D>         @                            35MG                                    N83922 001                  May  CAHN
>A>         @ TG UNITED LABS             35MG                                    N85321 001                  May  CAHN
>A>         @                            35MG                                    N85320 001                  May  CAHN
>A>         @                            35MG                                    N85318 001                  May  CAHN
>A>         @                            35MG                                    N83922 001                  May  CAHN
            PHENDIMETRAZINE TARTRATE
>D>         @ ABC HOLDING                35MG                                    N85941 001  Jun 27, 1983    May  CAHN
>D>         @                            35MG                                    N85761 001                  May  CAHN
>A>         @ TG UNITED LABS             35MG                                    N85941 001  Jun 27, 1983    May  CAHN
>A>         @                            35MG                                    N85761 001                  May  CAHN

        PHENTERMINE HYDROCHLORIDE
          CAPSULE; ORAL
            PHENTERMINE HYDROCHLORIDE
>D>         @ ABC HOLDING                18.75MG                                 N88576 001  May 23, 1984    May  CAHN
>D>         @                            30MG                                    N87215 001                  May  CAHN
>D>         @                            30MG                                    N86732 002                  May  CAHN
>D>         @                            30MG                                    N85417 001                  May  CAHN
>D>         @                            37.5MG                                  N88625 001  Aug 23, 1984    May  CAHN
>D>         @                            37.5MG                                  N88611 001  Jun 04, 1984    May  CAHN
>D>         @                            37.5MG                                  N88610 001  Jun 04, 1984    May  CAHN
>D>         @                            37.5MG                                  N87930 001  Oct 14, 1983    May  CAHN
>D>         @                            37.5MG                                  N87918 001  Dec 22, 1983    May  CAHN
>D>         @                            37.5MG                                  N87915 001  Dec 22, 1983    May  CAHN
>A>         @ TG UNITED LABS             18.75MG                                 N88576 001  May 23, 1984    May  CAHN
>A>         @                            30MG                                    N87215 001                  May  CAHN
>A>         @                            30MG                                    N86732 002                  May  CAHN
>A>         @                            30MG                                    N85417 001                  May  CAHN
>A>         @                            37.5MG                                  N88625 001  Aug 23, 1984    May  CAHN
>A>         @                            37.5MG                                  N88611 001  Jun 04, 1984    May  CAHN
>A>         @                            37.5MG                                  N88610 001  Jun 04, 1984    May  CAHN
>A>         @                            37.5MG                                  N87930 001  Oct 14, 1983    May  CAHN
>A>         @                            37.5MG                                  N87918 001  Dec 22, 1983    May  CAHN
>A>         @                            37.5MG                                  N87915 001  Dec 22, 1983    May  CAHN
          TABLET; ORAL
            PHENTERMINE HYDROCHLORIDE
>D>         @ ABC HOLDING                8MG                                     N85319 001                  May  CAHN
>D>         @                            8MG                                     N83923 001                  May  CAHN
>D>         @                            37.5MG                                  N88596 001  Apr 04, 1984    May  CAHN
>D>         @                            37.5MG                                  N87805 001  Dec 06, 1982    May  CAHN
>A>         @ TG UNITED LABS             8MG                                     N85319 001                  May  CAHN
>A>         @                            8MG                                     N83923 001                  May  CAHN
>A>         @                            37.5MG                                  N88596 001  Apr 04, 1984    May  CAHN
>A>         @                            37.5MG                                  N87805 001  Dec 06, 1982    May  CAHN


        POLYETHYLENE GLYCOL 3350
          FOR SOLUTION; ORAL
            POLYETHYLENE GLYCOL 3350
>A>   AA      COASTAL PHARMS             17GM/SCOOPFUL                           N77893 001  May 26, 2006    May  NEWA
>A>   AA      KALI LABS                  17GM/SCOOPFUL                           N77736 001  May 26, 2006    May  NEWA

        POTASSIUM CITRATE
          TABLET, EXTENDED RELEASE; ORAL
>A>         POTASSIUM CITRATE
>A>   AB      COREPHARMA                 5MEQ                                    N77440 001  Jun 09, 2006    May  NEWA
>A>   AB                                 10MEQ                                   N77440 002  Jun 09, 2006    May  NEWA
            UROCIT-K
>D>           MISSION PHARMA             5MEQ                                    N19071 001  Aug 30, 1985    May  CFTG
>A>   AB                                 5MEQ                                    N19071 001  Aug 30, 1985    May  CFTG
>D>       +                              10MEQ                                   N19071 002  Aug 31, 1992    May  CFTG
>A>   AB  +                              10MEQ                                   N19071 002  Aug 31, 1992    May  CFTG

        PREDNISOLONE ACETATE
          SUSPENSION/DROPS; OPHTHALMIC
>D>         ECONOPRED PLUS
>D>   AB      FALCON PHARMS              1%                                      N17469 001                  May  CTNA
>A>         OMNIPRED
>A>   AB      ALCON                      1%                                      N17469 001                  May  CTNA


        PROCHLORPERAZINE
          SUPPOSITORY; RECTAL
            COMPAZINE
>D>           GLAXOSMITHKLINE            2.5MG                                   N11127 003                  May  DISC
>A>         @                            2.5MG                                   N11127 003                  May  DISC
>D>                                      5MG                                     N11127 001                  May  DISC
>A>         @                            5MG                                     N11127 001                  May  DISC

        PROCHLORPERAZINE EDISYLATE
>D>       SYRUP; ORAL
>D>         COMPAZINE
>D>           GLAXOSMITHKLINE            EQ 5MG BASE/5ML                         N11188 001                  May  DISC
>A>         @                            EQ 5MG BASE/5ML                         N11188 001                  May  DISC


        PROCHLORPERAZINE MALEATE
          CAPSULE, EXTENDED RELEASE; ORAL
            COMPAZINE
>D>       +   GLAXOSMITHKLINE            EQ 10MG BASE                            N21019 001  Oct 06, 1999    May  DISC
>A>         @                            EQ 10MG BASE                            N21019 001  Oct 06, 1999    May  DISC

        PROGESTERONE
          GEL; VAGINAL
            CRINONE
>A>           COLUMBIA LABS              4%                                      N20701 001  Jul 31, 1997    May  CAHN
>A>       +                              8%                                      N20701 002  Jul 31, 1997    May  CAHN
>D>           COLUMBIA RES LABS          4%                                      N20701 001  Jul 31, 1997    May  CAHN
>D>       +                              8%                                      N20701 002  Jul 31, 1997    May  CAHN

        QUAZEPAM
          TABLET; ORAL
            DORAL
>D>         @ MEDPOINTE PHARM            7.5MG                                   N18708 003  Feb 26, 1987    May  CAHN
>D>       +                              15MG                                    N18708 001  Dec 27, 1985    May  CAHN
>A>         @ QUESTCOR PHARMS            7.5MG                                   N18708 003  Feb 26, 1987    May  CAHN
>A>       +                              15MG                                    N18708 001  Dec 27, 1985    May  CAHN


>A>     RASAGILINE MESYLATE
>A>       TABLET; ORAL
>A>         AZILECT
>A>           TEVA                       EQ 0.5MG BASE                           N21641 001  May 16, 2006    May  NEWA
>A>       +                              EQ 1MG BASE                             N21641 002  May 16, 2006    May  NEWA

        SECRETIN SYNTHETIC PORCINE
          FOR SOLUTION; INTRAVENOUS
>A>         SECREFLO
>A>       +   CHIRHOCLIN                 16UGM/VIAL                              N21136 001  Apr 04, 2002    May  CTNA
>D>         SECREMAX
>D>       +   CHIRHOCLIN                 16UGM/VIAL                              N21136 001  Apr 04, 2002    May  CTNA

        SODIUM CHLORIDE
          INJECTABLE; INJECTION
            SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
>D>   AP      B BRAUN                    900MG/100ML                             N19635 002  Mar 09, 1988    May  CRLD
>A>   AP  +                              900MG/100ML                             N19635 002  Mar 09, 1988    May  CRLD
>D>   AP                                 900MG/100ML                             N17464 001                  May  CRLD
>A>   AP  +                              900MG/100ML                             N17464 001                  May  CRLD
>D>   AP      BAXTER HLTHCARE            900MG/100ML                             N20178 001  Dec 07, 1992    May  CRLD
>A>   AP  +                              900MG/100ML                             N20178 001  Dec 07, 1992    May  CRLD
>D>   AP                                 900MG/100ML                             N16677 001                  May  CRLD
>A>   AP  +                              900MG/100ML                             N16677 001                  May  CRLD
>D>   AP      HOSPIRA                    900MG/100ML                             N19480 001  Sep 17, 1985    May  CRLD
>A>   AP  +                              900MG/100ML                             N19480 001  Sep 17, 1985    May  CRLD
>D>   AP                                 900MG/100ML                             N19465 001  Jul 15, 1985    May  CRLD
>A>   AP  +                              900MG/100ML                             N19465 001  Jul 15, 1985    May  CRLD
>D>   AP                                 900MG/100ML                             N16366 001                  May  CRLD
>A>   AP  +                              900MG/100ML                             N16366 001                  May  CRLD

        SOMATROPIN RECOMBINANT
          INJECTABLE; INJECTION
            GENOTROPIN
>D>       +   PHARMACIA AND              5.8MG/VIAL                              N20280 006  Aug 24, 1995    May  CTEC
>A>   BX  +                              5.8MG/VIAL                              N20280 006  Aug 24, 1995    May  CTEC
            GENOTROPIN PRESERVATIVE FREE
>D>           PHARMACIA AND              1.5MG/VIAL                              N20280 004  Aug 24, 1995    May  CTEC
>A>   BX                                 1.5MG/VIAL                              N20280 004  Aug 24, 1995    May  CTEC
>A>         OMNITROPE
>A>   BX      SANDOZ                     1.5MG/VIAL                              N21426 002  May 30, 2006    May  NEWA
>A>   BX                                 5.8MG/VIAL                              N21426 001  May 30, 2006    May  NEWA

>D>     TECHNETIUM TC-99M APCITIDE
>D>       INJECTABLE; INJECTION
>D>         ACUTECT
>D>           CIS BIO INTL SA            N/A                                     N20887 001  Sep 14, 1998    May  DISC
>A>         @                            N/A                                     N20887 001  Sep 14, 1998    May  DISC


>D>     TECHNETIUM TC-99M DEPREOTIDE
>D>       INJECTABLE; INJECTION
>D>         NEO TECT KIT
>D>       +   CIS BIO INTL SA            N/A                                     N21012 001  Aug 03, 1999    May  DISC
>A>         @                            N/A                                     N21012 001  Aug 03, 1999    May  DISC

        TECHNETIUM TC-99M TETROFOSMIN KIT
          INJECTABLE; INJECTION
>D>         MYOVIEW 30ML
>D>       +   GE HEALTHCARE              N/A                                     N20372 002  Jul 07, 2005    May  DISC
>A>         @                            N/A                                     N20372 002  Jul 07, 2005    May  DISC

        TESTOSTERONE ENANTHATE
          INJECTABLE; INJECTION
            TESTOSTERONE ETHANATE
>A>   AO      PADDOCK                    200MG/ML                                N40575 001  Jun 14, 2006    May  NEWA


        TETRACYCLINE HYDROCHLORIDE
          CAPSULE; ORAL
            ACHROMYCIN V
>A>         @ RADIUS PHARMS              250MG                                   N50278 003                  May  CAHN
>A>         @                            500MG                                   N50278 001                  May  CAHN
>D>         @ SCIREG INTL INC            250MG                                   N50278 003                  May  CAHN
>D>         @                            500MG                                   N50278 001                  May  CAHN

>D>     TICARCILLIN DISODIUM
>D>       INJECTABLE; INJECTION
>D>         TICAR
>D>       +   GLAXOSMITHKLINE            EQ 1GM BASE/VIAL                        N50497 001                  May  DISC
>A>         @                            EQ 1GM BASE/VIAL                        N50497 001                  May  DISC
>D>       +                              EQ 3GM BASE/VIAL                        N50497 002                  May  DISC
>A>         @                            EQ 3GM BASE/VIAL                        N50497 002                  May  DISC
>D>       +                              EQ 20GM BASE/VIAL                       N50497 004                  May  DISC
>A>         @                            EQ 20GM BASE/VIAL                       N50497 004                  May  DISC
>D>       +                              EQ 30GM BASE/VIAL                       N50497 005  Apr 04, 1984    May  DISC
>A>         @                            EQ 30GM BASE/VIAL                       N50497 005  Apr 04, 1984    May  DISC

        TRIAMCINOLONE ACETONIDE
          CREAM; TOPICAL
            TRIAMCINOLONE ACETONIDE
>A>   AT      VINTAGE                    0.025%                                  N40671 001  Jun 09, 2006    May  NEWA
>A>   AT                                 0.1%                                    N40671 002  Jun 09, 2006    May  NEWA


        TRICHLORMETHIAZIDE
          TABLET; ORAL
            TRICHLORMETHIAZIDE
>D>         @ ABC HOLDING                4MG                                     N85568 001                  May  CAHN
>A>         @ TG UNITED LABS             4MG                                     N85568 001                  May  CAHN

        TRIFLUOPERAZINE HYDROCHLORIDE
>D>       INJECTABLE; INJECTION
>D>         STELAZINE
>D>       +   GLAXOSMITHKLINE            EQ 2MG BASE/ML                          N11552 005                  May  DISC
>A>         @                            EQ 2MG BASE/ML                          N11552 005                  May  DISC


>A>     VARENICLINE TARTRATE
>A>       TABLET; ORAL
>A>         CHANTIX
>A>           PFIZER                     EQ 0.5MG BASE                           N21928 001  May 10, 2006    May  NEWA
>A>       +                              EQ 1MG BASE                             N21928 002  May 10, 2006    May  NEWA

        WARFARIN SODIUM
          TABLET; ORAL
            WARFARIN SODIUM
>A>   AB      ZYDUS PHARMS USA           1MG                                     N40663 001  May 30, 2006    May  NEWA
>A>   AB                                 2MG                                     N40663 002  May 30, 2006    May  NEWA
>A>   AB                                 2.5MG                                   N40663 003  May 30, 2006    May  NEWA
>A>   AB                                 3MG                                     N40663 004  May 30, 2006    May  NEWA
>A>   AB                                 4MG                                     N40663 005  May 30, 2006    May  NEWA
>A>   AB                                 5MG                                     N40663 006  May 30, 2006    May  NEWA
>A>   AB                                 6MG                                     N40663 007  May 30, 2006    May  NEWA
>A>   AB                                 7.5MG                                   N40663 008  May 30, 2006    May  NEWA
>A>   AB                                 10MG                                    N40663 009  May 30, 2006    May  NEWA


        ZONISAMIDE
          CAPSULE; ORAL
            ZONISAMIDE
>A>   AB      INVAGEN PHARMS             25MG                                    N77869 001  May 31, 2006    May  NEWA
>A>   AB                                 50MG                                    N77869 002  May 31, 2006    May  NEWA
>A>   AB                                 100MG                                   N77869 003  May 31, 2006    May  NEWA

ADDITIONS/DELETIONS FOR OTC DRUG PRODUCT LIST

 

       DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
          TABLET, EXTENDED RELEASE; ORAL
            MUCINEX DM
>D>           ADAMS LABS INC             30MG;600MG                              N21620 002  Apr 29, 2004    May  CAHN
>D>       +                              60MG;1.2GM                              N21620 001  Apr 29, 2004    May  CAHN
>A>           ADAMS RESP THERAP          30MG;600MG                              N21620 002  Apr 29, 2004    May  CAHN
>A>       +                              60MG;1.2GM                              N21620 001  Apr 29, 2004    May  CAHN

        GUAIFENESIN
          TABLET, EXTENDED RELEASE; ORAL
            MUCINEX
>D>           ADAMS LABS INC             600MG                                   N21282 001  Jul 12, 2002    May  CAHN
>D>       +                              1.2GM                                   N21282 002  Dec 18, 2002    May  CAHN
>A>           ADAMS RESP THERAP          600MG                                   N21282 001  Jul 12, 2002    May  CAHN
>A>       +                              1.2GM                                   N21282 002  Dec 18, 2002    May  CAHN

        GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
          TABLET, EXTENDED RELEASE; ORAL
            MUCINEX D
>D>           ADAMS LABS INC             600MG;60MG                              N21585 001  Jun 22, 2004    May  CAHN
>D>       +                              1.2GM;120MG                             N21585 002  Jun 22, 2004    May  CAHN
>A>           ADAMS RESP THERAP          600MG;60MG                              N21585 001  Jun 22, 2004    May  CAHN
>A>       +                              1.2GM;120MG                             N21585 002  Jun 22, 2004    May  CAHN

Date created: June 16, 2006

horizonal rule