[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 3: March 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

      ACETAMINOPHEN; HYDROCODONE BITARTRATE
          TABLET; ORAL
            HYDROCODONE BITARTRATE AND ACETAMINOPHEN
>A>       +   MIKART                     300MG;7.5MG                             N40556 002  Mar 24, 2006    Mar  NEWA
>D>         HY-PHEN
>D>   AA      ASCHER                     500MG;5MG                               N87677 001  May 03, 1982    Mar  DISC
>A>         @                            500MG;5MG                               N87677 001  May 03, 1982    Mar  DISC

        ACETAZOLAMIDE
          TABLET; ORAL
            ACETAZOLAMIDE
>D>   AB      TARO                       250MG                                   N40195 002  May 28, 1997    Mar  CRLD
>A>   AB  +                              250MG                                   N40195 002  May 28, 1997    Mar  CRLD
>D>         DIAMOX
>D>   AB      DURAMED PHARMS             125MG                                   N08943 001                  Mar  DISC
>A>         @                            125MG                                   N08943 001                  Mar  DISC
>D>   AB  +                              250MG                                   N08943 002                  Mar  DISC
>A>         @                            250MG                                   N08943 002                  Mar  DISC

        ALBUTEROL SULFATE
          SOLUTION; INHALATION
            ALBUTEROL SULFATE
>A>   AN      RXELITE                    EQ 0.083% BASE                          N77569 001  Apr 04, 2006    Mar  NEWA

        AMOXICILLIN
          TABLET; ORAL
            AMOXICILLIN
>A>   AB      HIKMA                      875MG                                   N65255 001  Mar 29, 2006    Mar  NEWA

        ARTICAINE HYDROCHLORIDE; EPINEPHRINE
          INJECTABLE; INJECTION
>A>         SEPTOCAINE
>A>           DEPROCO                    4%;EQ 0.005MG BASE/ML                   N22010 001  Mar 30, 2006    Mar  NEWA
>D>       +                              4%;EQ 0.01MG BASE/ML                    N20971 001  Apr 03, 2000    Mar  CPOT
>A>       +                              4%; EQ 0.017MG BASE/1.7ML (4%; EQ       N20971 001  Apr 03, 2000    Mar  CPOT

>D>     BENZQUINAMIDE HYDROCHLORIDE
>D>       INJECTABLE; INJECTION
>D>         EMETE-CON
>D>       +   PFIZER                     EQ 50MG BASE/VIAL                       N16820 001                  Mar  DISC
>A>         @                            EQ 50MG BASE/VIAL                       N16820 001                  Mar  DISC

        BUDESONIDE
          SPRAY, METERED; NASAL
            RHINOCORT
>D>           ASTRAZENECA                0.032MG/INH                             N20746 001  Oct 01, 1999    Mar  CRLD
>A>       +                              0.032MG/INH                             N20746 001  Oct 01, 1999    Mar  CRLD
>D>       +                              0.064MG/INH                             N20746 002  Oct 01, 1999    Mar  DISC
>A>         @                            0.064MG/INH                             N20746 002  Oct 01, 1999    Mar  DISC

        CALCITRIOL
          CAPSULE; ORAL
            CALCITRIOL
>A>   AB      ROXANE                     0.25UGM                                 N76917 001  Mar 27, 2006    Mar  NEWA


        CEFADROXIL/CEFADROXIL HEMIHYDRATE
          CAPSULE; ORAL
            CEFADROXIL
>D>   AB      IVAX PHARMS                EQ 500MG BASE                           N62766 001  Mar 03, 1987    Mar  CRLD
>A>   AB  +                              EQ 500MG BASE                           N62766 001  Mar 03, 1987    Mar  CRLD
          TABLET; ORAL
            CEFADROXIL
>A>   AB      HIKMA                      EQ 1GM BASE                             N65260 001  Mar 30, 2006    Mar  NEWA


        CEFUROXIME AXETIL
          TABLET; ORAL
            CEFUROXIME AXETIL
>A>   AB      AUROBINDO PHARMA           EQ 125MG BASE                           N65308 001  Mar 29, 2006    Mar  NEWA
>A>   AB                                 EQ 250MG BASE                           N65308 002  Mar 29, 2006    Mar  NEWA
>A>   AB                                 EQ 500MG BASE                           N65308 003  Mar 29, 2006    Mar  NEWA

        CEPHRADINE
          CAPSULE; ORAL
            ANSPOR
>D>   AB      GLAXOSMITHKLINE            250MG                                   N61859 001                  Mar  DISC
>A>         @                            250MG                                   N61859 001                  Mar  DISC
>D>   AB                                 500MG                                   N61859 002                  Mar  DISC
>A>         @                            500MG                                   N61859 002                  Mar  DISC

        CICLOPIROX
          CREAM; TOPICAL
            CICLOPIROX
>A>   AB      PERRIGO                    0.77%                                   N77364 001  Mar 03, 2006    Mar  CAHN
>D>   AB      PERRIGO NEW YORK           0.77%                                   N77364 001  Mar 03, 2006    Mar  CAHN

        CILOSTAZOL
          TABLET; ORAL
            CILOSTAZOL
>A>   AB      MUTUAL PHARM               50MG                                    N77208 002  Mar 29, 2006    Mar  NEWA
>A>   AB                                 100MG                                   N77208 001  Mar 29, 2006    Mar  NEWA

        CITALOPRAM HYDROBROMIDE
          TABLET; ORAL
            CITALOPRAM HYDROBROMIDE
>A>   AB      TARO                       EQ 10MG BASE                            N77278 001  Mar 22, 2006    Mar  NEWA
>A>   AB                                 EQ 20MG BASE                            N77278 002  Mar 22, 2006    Mar  NEWA
>A>   AB                                 EQ 40MG BASE                            N77278 003  Mar 22, 2006    Mar  NEWA
>A>   AB      TEVA PHARMS                EQ 10MG BASE                            N77213 001  Mar 31, 2006    Mar  NEWA
>A>   AB                                 EQ 20MG BASE                            N77213 002  Mar 31, 2006    Mar  NEWA
>A>   AB                                 EQ 40MG BASE                            N77213 003  Mar 31, 2006    Mar  NEWA

        CYANOCOBALAMIN
>D>       GEL, METERED; NASAL
>D>         NASCOBAL
>D>       +   QOL MEDCL                  0.5MG/INH                               N19722 001  Nov 05, 1996    Mar  DISC
>A>         @                            0.5MG/INH                               N19722 001  Nov 05, 1996    Mar  DISC

        CYCLOBENZAPRINE HYDROCHLORIDE
          TABLET; ORAL
            CYCLOBENZAPRINE HYDROCHLORIDE
>A>   AB      MUTUAL PHARM               5MG                                     N73541 002  Apr 06, 2006    Mar  NEWA

        DEFEROXAMINE MESYLATE
          INJECTABLE; INJECTION
            DEFEROXAMINE MESYLATE
>A>   AP      SICOR PHARMS               500MG/VIAL                              N76806 001  Mar 31, 2006    Mar  NEWA
>A>   AP                                 2GM/VIAL                                N76806 002  Mar 31, 2006    Mar  NEWA

        DEMECLOCYCLINE HYDROCHLORIDE
          TABLET; ORAL
            DECLOMYCIN
>A>         @ GLADES PHARMS LLC          75MG                                    N50261 001                  Mar  CAHN
>A>   AB                                 150MG                                   N50261 002                  Mar  CAHN
>A>   AB  +                              300MG                                   N50261 003                  Mar  CAHN
>D>         @ PROTEIN DESIGN             75MG                                    N50261 001                  Mar  CAHN
>D>   AB                                 150MG                                   N50261 002                  Mar  CAHN
>D>   AB  +                              300MG                                   N50261 003                  Mar  CAHN

        DEXAMETHASONE SODIUM PHOSPHATE
          INJECTABLE; INJECTION
            DEXAMETHASONE
>A>   AP      BAXTER HLTHCARE            EQ 10MG PHOSPHATE/ML                    N87702 001  Sep 07, 1982    Mar  CAHN
>D>   AP      ELKINS SINN                EQ 10MG PHOSPHATE/ML                    N87702 001  Sep 07, 1982    Mar  CAHN


        DIAZEPAM
          TABLET; ORAL
            DIAZEPAM
>A>   AB      VINTAGE PHARMS             2MG                                     N77749 001  Mar 31, 2006    Mar  NEWA
>A>   AB                                 5MG                                     N77749 002  Mar 31, 2006    Mar  NEWA
>A>   AB                                 10MG                                    N77749 003  Mar 31, 2006    Mar  NEWA

>A>     DOLASETRON MESYLATE
>A>       INJECTABLE; INJECTION
>A>         ANZEMET
>A>       +   SANOFI AVENTIS US          EQ 12.5MG BASE/0.625ML (EQ 20MG         N20624 002  Sep 11, 1997    Mar  CAIN
>A>       +                              EQ 100MG BASE/5ML (EQ 20MG BASE/ML)     N20624 001  Sep 11, 1997    Mar  CAIN
>A>       +                              EQ 500MG BASE/25ML (EQ 20MG             N20624 003  Dec 11, 2001    Mar  CAIN
>A>       TABLET; ORAL
>A>         ANZEMET
>A>           SANOFI AVENTIS US          EQ 50MG BASE                            N20623 001  Sep 11, 1997    Mar  CAIN
>A>       +                              EQ 100MG BASE                           N20623 002  Sep 11, 1997    Mar  CAIN


>D>     DOLASETRON MESYLATE MONOHYDRATE
>D>       INJECTABLE; INJECTION
>D>         ANZEMET
>D>           SANOFI AVENTIS US          EQ 12.5MG BASE/0.625ML                  N20624 002  Sep 11, 1997    Mar  CAIN
>D>       +                              EQ 100MG BASE/5ML                       N20624 001  Sep 11, 1997    Mar  CAIN
>D>       +                              EQ 500MG BASE/25ML                      N20624 003  Dec 11, 2001    Mar  CAIN
>D>       TABLET; ORAL
>D>         ANZEMET
>D>           SANOFI AVENTIS US          EQ 50MG BASE                            N20623 001  Sep 11, 1997    Mar  CAIN
>D>       +                              EQ 100MG BASE                           N20623 002  Sep 11, 1997    Mar  CAIN

        DOXYCYCLINE
          CAPSULE; ORAL
            DOXYCYCLINE
>D>   AB      PAR PHARM                  EQ 75MG BASE                            N65055 004  Apr 18, 2005    Mar  DISC
>A>         @                            EQ 75MG BASE                            N65055 004  Apr 18, 2005    Mar  DISC
>D>                                      EQ 150MG BASE                           N65055 003  Jul 15, 2005    Mar  DISC
>A>         @                            EQ 150MG BASE                           N65055 003  Jul 15, 2005    Mar  DISC
>D>   AB      RANBAXY                    EQ 75MG BASE                            N65053 003  Sep 10, 2003    Mar  CTEC
>A>                                      EQ 75MG BASE                            N65053 003  Sep 10, 2003    Mar  CTEC
          TABLET; ORAL
            DOXYCYCLINE
>D>         @ PAR PHARM                  EQ 75MG BASE                            N65070 003  Dec 30, 2002    Mar  CMFD
>A>                                      EQ 75MG BASE                            N65070 003  Dec 30, 2002    Mar  CMFD

        DROSPIRENONE; ETHINYL ESTRADIOL
          TABLET; ORAL
>A>         YAZ
>A>       +   BERLEX LABS                3MG;0.02MG                              N21676 001  Mar 16, 2006    Mar  NEWA


        EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
          INJECTABLE; INJECTION
            XYLOCAINE W/ EPINEPHRINE
>D>           DENTSPLY PHARM             0.02MG/ML;2%                            N21381 002                  Mar  CRLD
>A>       +                              0.02MG/ML;2%                            N21381 002                  Mar  CRLD

        ESTROGENS, CONJUGATED SYNTHETIC B
          TABLET; ORAL
            ENJUVIA
>D>         @ DURAMED                    0.3MG                                   N21443 001  Dec 20, 2004    Mar  CMFD
>A>                                      0.3MG                                   N21443 001  Dec 20, 2004    Mar  CMFD
>D>         @                            0.45MG                                  N21443 002  Dec 20, 2004    Mar  CMFD
>A>                                      0.45MG                                  N21443 002  Dec 20, 2004    Mar  CMFD
>D>         @                            0.625MG                                 N21443 003  May 10, 2004    Mar  CMFD
>A>                                      0.625MG                                 N21443 003  May 10, 2004    Mar  CMFD
>D>         @                            1.25MG                                  N21443 004  May 10, 2004    Mar  CMFD
>A>       +                              1.25MG                                  N21443 004  May 10, 2004    Mar  CMFD


        ETHINYL ESTRADIOL; NORETHINDRONE
          TABLET; ORAL-21
            BALZIVA-21
>D>       +   BARR                       0.035MG;0.4MG                           N76198 001  Apr 22, 2004    Mar  CRLD
>A>                                      0.035MG;0.4MG                           N76198 001  Apr 22, 2004    Mar  CRLD
          TABLET; ORAL-28
            OVCON-35
>D>   AB      WARNER CHILCOTT            0.035MG;0.4MG                           N17716 001                  Mar  CRLD
>A>   AB  +                              0.035MG;0.4MG                           N17716 001                  Mar  CRLD

        ETODOLAC
          CAPSULE; ORAL
            ETODOLAC
>D>   AB      TARO                       300MG                                   N75078 002  Apr 30, 1998    Mar  CRLD
>A>   AB  +                              300MG                                   N75078 002  Apr 30, 1998    Mar  CRLD
>D>         LODINE
>D>   AB  +   WYETH PHARMS INC           300MG                                   N18922 003  Jan 31, 1991    Mar  DISC
>A>         @                            300MG                                   N18922 003  Jan 31, 1991    Mar  DISC

        FENTANYL CITRATE
          TROCHE/LOZENGE; TRANSMUCOSAL
>D>         ACTIQ
>D>           CEPHALON                   EQ 0.2MG BASE                           N20747 001  Nov 04, 1998    Mar  CTNA
>D>       +                              EQ 0.4MG BASE                           N20747 002  Nov 04, 1998    Mar  CTNA
>D>                                      EQ 0.6MG BASE                           N20747 003  Nov 04, 1998    Mar  CTNA
>D>                                      EQ 0.8MG BASE                           N20747 004  Nov 04, 1998    Mar  CTNA
>D>                                      EQ 1.2MG BASE                           N20747 005  Nov 04, 1998    Mar  CTNA
>D>                                      EQ 1.6MG BASE                           N20747 006  Nov 04, 1998    Mar  CTNA
>A>         ACTIQ (SUGAR-FREE)
>A>           CEPHALON                   EQ 0.2MG BASE                           N20747 001  Nov 04, 1998    Mar  CTNA
>A>       +                              EQ 0.4MG BASE                           N20747 002  Nov 04, 1998    Mar  CTNA
>A>                                      EQ 0.6MG BASE                           N20747 003  Nov 04, 1998    Mar  CTNA
>A>                                      EQ 0.8MG BASE                           N20747 004  Nov 04, 1998    Mar  CTNA
>A>                                      EQ 1.2MG BASE                           N20747 005  Nov 04, 1998    Mar  CTNA
>A>                                      EQ 1.6MG BASE                           N20747 006  Nov 04, 1998    Mar  CTNA

        FEXOFENADINE HYDROCHLORIDE
          TABLET; ORAL
            FEXOFENADINE HYDROCHLORIDE
>A>   AB      DR REDDYS LABS             30MG                                    N76502 001  Apr 11, 2006    Mar  NEWA
>A>   AB                                 60MG                                    N76502 002  Apr 11, 2006    Mar  NEWA
>A>   AB                                 180MG                                   N76502 003  Apr 11, 2006    Mar  NEWA

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


        FLUOROURACIL
          INJECTABLE; INJECTION
            ADRUCIL
>D>   AP      SICOR PHARMS               50MG/ML                                 N40023 001  Oct 18, 1991    Mar  CRLD
>A>   AP  +                              50MG/ML                                 N40023 001  Oct 18, 1991    Mar  CRLD
            FLUOROURACIL
>D>   AP      AM PHARM                   50MG/ML                                 N40291 001  Mar 24, 1999    Mar  CRLD
>D>   AP      AM PHARM                   50MG/ML                                 N40379 001  Nov 15, 2000    Mar  CRLD
>A>   AP  +                              50MG/ML                                 N40379 001  Nov 15, 2000    Mar  CRLD
>A>   AP  +                              50MG/ML                                 N40291 001  Mar 24, 1999    Mar  CRLD
>D>   AP                                 50MG/ML                                 N40279 001  Sep 30, 1998    Mar  CRLD
>A>   AP  +                              50MG/ML                                 N40279 001  Sep 30, 1998    Mar  CRLD
>D>   AP                                 50MG/ML                                 N40278 001  Sep 30, 1998    Mar  CRLD
>A>   AP  +                              50MG/ML                                 N40278 001  Sep 30, 1998    Mar  CRLD
>D>   AP      BEDFORD                    50MG/ML                                 N89508 001  Jan 26, 1988    Mar  CRLD
>A>   AP  +                              50MG/ML                                 N89508 001  Jan 26, 1988    Mar  CRLD
>D>   AP      SICOR PHARMS               50MG/ML                                 N40334 001  Feb 25, 2000    Mar  CRLD
>A>   AP  +                              50MG/ML                                 N40334 001  Feb 25, 2000    Mar  CRLD
>D>   AP                                 50MG/ML                                 N40333 001  Jan 27, 2000    Mar  CRLD
>A>   AP  +                              50MG/ML                                 N40333 001  Jan 27, 2000    Mar  CRLD
>D>   AP      STERIS                     50MG/ML                                 N87792 001  Oct 13, 1982    Mar  CRLD
>A>   AP  +                              50MG/ML                                 N87792 001  Oct 13, 1982    Mar  CRLD

        FLUVOXAMINE MALEATE
          TABLET; ORAL
            FLUVOXAMINE MALEATE
>A>   AB      LEINER                     25MG                                    N75888 001  Nov 29, 2000    Mar  CAHN
>A>   AB                                 50MG                                    N75888 002  Nov 29, 2000    Mar  CAHN
>A>   AB  +                              100MG                                   N75888 003  Nov 29, 2000    Mar  CAHN
>D>   AB      SANDOZ                     25MG                                    N75888 001  Nov 29, 2000    Mar  CAHN
>D>   AB                                 50MG                                    N75888 002  Nov 29, 2000    Mar  CAHN
>D>   AB  +                              100MG                                   N75888 003  Nov 29, 2000    Mar  CAHN

        GLIPIZIDE
          TABLET, EXTENDED RELEASE; ORAL
            GLIPIZIDE
>A>   AB      WATSON LABS                2.5MG                                   N76467 003  Mar 27, 2006    Mar  NEWA
            GLUCOTROL XL
>D>           PFIZER                     2.5MG                                   N20329 003  Aug 10, 1999    Mar  CFTG
>A>   AB                                 2.5MG                                   N20329 003  Aug 10, 1999    Mar  CFTG

        HALOBETASOL PROPIONATE
          OINTMENT; TOPICAL
            HALOBETASOL PROPIONATE
>D>   AB      AGIS INDS                  0.05%                                   N76872 001  Dec 16, 2004    Mar  CAHN
>A>   AB      PERRIGO                    0.05%                                   N76872 001  Dec 16, 2004    Mar  CAHN

        HYDROCORTISONE SODIUM SUCCINATE
          INJECTABLE; INJECTION
            A-HYDROCORT
>A>   AP      HOSPIRA                    EQ 100MG BASE/VIAL                      N40666 001  Apr 06, 2006    Mar  NEWA

        HYDROXYZINE PAMOATE
          CAPSULE; ORAL
            HYDROXYZINE PAMOATE
>D>   AB      BARR                       EQ 100MG HCL                            N88488 001  Jun 15, 1984    Mar  CTEC
>A>                                      EQ 100MG HCL                            N88488 001  Jun 15, 1984    Mar  CTEC
            VISTARIL
>D>   AB      PFIZER                     EQ 100MG HCL                            N11459 006                  Mar  DISC
>A>         @                            EQ 100MG HCL                            N11459 006                  Mar  DISC


        INSULIN GLULISINE RECOMBINANT
          INJECTABLE; SUBCUTANEOUS
            APIDRA
>D>         @ SANOFI AVENTIS US          1000 UNITS/10ML (100 UNITS/ML)          N21629 001  Apr 16, 2004    Mar  CMFD
>A>       +                              1000 UNITS/10ML (100 UNITS/ML)          N21629 001  Apr 16, 2004    Mar  CMFD
>D>         @                            300 UNITS/3ML (100 UNITS/ML)            N21629 002  Dec 20, 2005    Mar  CMFD
>A>       +                              300 UNITS/3ML (100 UNITS/ML)            N21629 002  Dec 20, 2005    Mar  CMFD

        ISOSORBIDE MONONITRATE
          TABLET, EXTENDED RELEASE; ORAL
            ISOSORBIDE MONONITRATE
>A>   AB      WEST WARD                  30MG                                    N76813 002  Mar 30, 2006    Mar  NEWA

        LEVETIRACETAM
          TABLET; ORAL
            KEPPRA
>D>       +   UCB INC                    750MG                                   N21035 003  Nov 30, 1999    Mar  CRLD
>A>                                      750MG                                   N21035 003  Nov 30, 1999    Mar  CRLD
>A>       +                              1GM                                     N21035 004  Jan 06, 2006    Mar  NEWA


        LORAZEPAM
          TABLET; ORAL
            LORAZEPAM
>A>   AB      MYLAN                      0.5MG                                   N77657 001  Mar 16, 2006    Mar  NEWA
>A>   AB                                 1MG                                     N77657 002  Mar 16, 2006    Mar  NEWA
>A>   AB                                 2MG                                     N77657 003  Mar 16, 2006    Mar  NEWA

>A>     MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE
>A>       TABLET, CHEWABLE; ORAL
>A>         ZEGERID
>A>           SANTARUS                   700MG;20MG;600MG                        N21850 001  Mar 24, 2006    Mar  NEWA
>A>       +                              700MG;40MG;600MG                        N21850 002  Mar 24, 2006    Mar  NEWA


        MIDAZOLAM HYDROCHLORIDE
          INJECTABLE; INJECTION
            MIDAZOLAM HYDROCHLORIDE
>D>   AP      HOSPIRA                    EQ 5MG BASE/ML                          N75293 002  Jun 20, 2000    Mar  CRLD
>A>   AP  +                              EQ 5MG BASE/ML                          N75293 002  Jun 20, 2000    Mar  CRLD

        MITOXANTRONE HYDROCHLORIDE
          INJECTABLE; INJECTION
>A>         MITOXANTRONE
>A>   AP      AM PHARM                   EQ 20MG BASE/10ML (2MG/ML)              N77496 001  Apr 11, 2006    Mar  NEWA
>A>   AP                                 EQ 25MG BASE/12.5ML (2MG/ML)            N77496 002  Apr 11, 2006    Mar  NEWA
>A>   AP                                 EQ 30MG BASE/15ML (2MG/ML)              N77496 003  Apr 11, 2006    Mar  NEWA
>A>   AP      BEDFORD                    EQ 20MG BASE/10ML (2MG/ML)              N76611 001  Apr 11, 2006    Mar  NEWA
>A>   AP                                 EQ 25MG BASE/12.5ML (2MG/ML)            N76611 002  Apr 11, 2006    Mar  NEWA
>A>   AP                                 EQ 30MG BASE/15ML (2MG/ML)              N76611 003  Apr 11, 2006    Mar  NEWA
>A>   AP      MAYNE PHARMA USA           EQ 20MG BASE/10ML (2MG/ML)              N76871 001  Apr 11, 2006    Mar  NEWA
>A>   AP                                 EQ 25MG BASE/12.5ML (2MG/ML)            N76871 002  Apr 11, 2006    Mar  NEWA
>A>   AP                                 EQ 30MG BASE/15ML (2MG/ML)              N76871 003  Apr 11, 2006    Mar  NEWA
>A>   AP      SICOR PHARMS               EQ 20MG BASE/10ML (2MG/ML)              N77356 001  Apr 11, 2006    Mar  NEWA
>A>   AP                                 EQ 25MG BASE/12.5ML (2MG/ML)            N77356 002  Apr 11, 2006    Mar  NEWA
>A>   AP                                 EQ 30MG BASE/15ML (2MG/ML)              N77356 003  Apr 11, 2006    Mar  NEWA
            NOVANTRONE
>D>       +   SERONO INC                 EQ 20MG BASE/10 MG (2MG/ML)             N19297 001  Dec 23, 1987    Mar  CFTG
>A>   AP  +                              EQ 20MG BASE/10ML(2MG/ML)               N19297 001  Dec 23, 1987    Mar  CFTG
>D>       +                              EQ 25MG BASE/12.5ML (2MG/ML)            N19297 002  Dec 23, 1987    Mar  CFTG
>A>   AP  +                              EQ 25MG BASE/12.5ML (2MG/ML)            N19297 002  Dec 23, 1987    Mar  CFTG
>D>       +                              EQ 30MG BASE/15ML (2MG/ML)              N19297 003  Dec 23, 1987    Mar  CFTG
>A>   AP  +                              EQ 30MG BASE/15ML (2MG/ML)              N19297 003  Dec 23, 1987    Mar  CFTG


        MOMETASONE FUROATE
          LOTION; TOPICAL
            MOMETASONE FUROATE
>D>   AB      AGIS INDS                  0.1%                                    N77180 001  Apr 06, 2005    Mar  CAHN
>A>   AB      PERRIGO                    0.1%                                    N77180 001  Apr 06, 2005    Mar  CAHN

        MORPHINE SULFATE
          INJECTABLE; INJECTION
            MORPHINE SULFATE
>A>           HOSPIRA                    5MG/ML                                  N19916 002  Mar 30, 2006    Mar  NEWA

        PILOCARPINE HYDROCHLORIDE
          TABLET; ORAL
            PILOCARPINE HYDROCHLORIDE
>A>   AB      IMPAX LABS                 5MG                                     N77248 001  Mar 31, 2006    Mar  NEWA
>A>   AB                                 7.5MG                                   N77248 002  Mar 31, 2006    Mar  NEWA
            SALAGEN
>D>       +   MGI PHARMA INC             7.5MG                                   N20237 002  Apr 18, 2003    Mar  CFTG
>A>   AB  +                              7.5MG                                   N20237 002  Apr 18, 2003    Mar  CFTG


        PREDNISOLONE ACETATE
>D>       INJECTABLE; INJECTION
>D>         PREDNISOLONE ACETATE
>D>       +   STERIS                     25MG/ML                                 N83398 001                  Mar  DISC
>A>         @                            25MG/ML                                 N83398 001                  Mar  DISC
>D>       +                              50MG/ML                                 N83764 001                  Mar  DISC
>A>         @                            50MG/ML                                 N83764 001                  Mar  DISC

        PROMETHAZINE HYDROCHLORIDE
          SUPPOSITORY; RECTAL
>D>         PHENERGAN
>D>   AB      WYETH PHARMS INC           12.5MG                                  N10926 002                  Mar  DISC
>A>         @                            12.5MG                                  N10926 002                  Mar  DISC
>D>   AB  +                              25MG                                    N10926 001                  Mar  DISC
>A>         @                            25MG                                    N10926 001                  Mar  DISC
            PROMETHAZINE HYDROCHLORIDE
>D>   AB      G AND W LABS               25MG                                    N40428 001  Feb 05, 2002    Mar  CRLD
>A>   AB  +                              25MG                                    N40428 001  Feb 05, 2002    Mar  CRLD

        PROPOFOL
          INJECTABLE; INJECTION
            PROPOFOL
>A>   AB      HOSPIRA                    10MG/ML                                 N77908 001  Mar 17, 2006    Mar  NEWA


        PROPOXYPHENE HYDROCHLORIDE
          CAPSULE; ORAL
            PROPOXYPHENE HYDROCHLORIDE
>D>   AA      IVAX PHARMS                65MG                                    N80269 001                  Mar  CAHN
>A>   AA      PAR PHARM                  65MG                                    N80269 001                  Mar  CAHN

        RISPERIDONE
          TABLET, ORALLY DISINTEGRATING; ORAL
            RISPERDAL
>D>         @ JANSSEN PHARMA             3MG                                     N21444 004  Dec 23, 2004    Mar  CMFD
>A>                                      3MG                                     N21444 004  Dec 23, 2004    Mar  CMFD
>D>         @                            4MG                                     N21444 005  Dec 23, 2004    Mar  CMFD
>A>                                      4MG                                     N21444 005  Dec 23, 2004    Mar  CMFD

>A>     SELEGILINE
>A>       FILM, EXTENDED RELEASE; TRANSDERMAL
>A>         EMSAM
>A>           SOMERSET                   6MG/24HR                                N21336 001  Feb 27, 2006    Mar  CAIN
>A>                                      9MG/24HR                                N21336 002  Feb 27, 2006    Mar  CAIN
>A>       +                              12MG/24HR                               N21336 003  Feb 27, 2006    Mar  CAIN

>D>     SELEGILINE HYDROCHLORIDE
>D>       FILM, EXTENDED RELEASE; TRANSDERMAL
>D>         EMSAM
>D>           SOMERSET                   6MG/24HR                                N21336 001  Feb 27, 2006    Mar  CAIN
>D>                                      9MG/24HR                                N21336 002  Feb 27, 2006    Mar  CAIN
>D>       +                              12MG/24HR                               N21336 003  Feb 27, 2006    Mar  CAIN

        SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
          TABLET; ORAL
>A>         OSMOPREP
>A>       +   SALIX PHARMS               0.398GM;1.102GM                         N21892 001  Mar 16, 2006    Mar  NEWA

        TERCONAZOLE
          SUPPOSITORY; VAGINAL
            TERAZOL 3
>D>       +   ORTHO MCNEIL               80MG                                    N19641 001  May 24, 1988    Mar  CFTG
>A>   AB  +                              80MG                                    N19641 001  May 24, 1988    Mar  CFTG
>A>         TERCONAZOLE
>A>   AB      PERRIGO NEW YORK           80MG                                    N77149 001  Mar 17, 2006    Mar  NEWA

>D>     TROLEANDOMYCIN
>D>       CAPSULE; ORAL
>D>         TAO
>D>       +   PFIZER                     EQ 250MG BASE                           N50336 002                  Mar  DISC
>A>         @                            EQ 250MG BASE                           N50336 002                  Mar  DISC

        ZIDOVUDINE
          CAPSULE; ORAL
            RETROVIR
>D>       +   GLAXOSMITHKLINE            100MG                                   N19655 001  Mar 19, 1987    Mar  CFTG
>A>   AB  +                              100MG                                   N19655 001  Mar 19, 1987    Mar  CFTG
>A>         ZIDOVUDINE
>A>   AB      AUROBINDO PHARMA           100MG                                   N78128 001  Mar 27, 2006    Mar  NEWA


        ZIPRASIDONE HYDROCHLORIDE
>A>       SUSPENSION; ORAL
>A>         GEODON
>A>       +   PFIZER INC                 EQ 10MG BASE/ML                         N21483 001  Mar 29, 2006    Mar  NEWA

        ZONISAMIDE
          CAPSULE; ORAL
            ZONISAMIDE
>A>   AB      SUN PHARM INDS (IN)        25MG                                    N77634 001  Mar 17, 2006    Mar  NEWA
>A>   AB                                 50MG                                    N77634 002  Mar 17, 2006    Mar  NEWA
>A>   AB                                 100MG                                   N77634 003  Mar 17, 2006    Mar  NEWA


ADDITIONS/DELETIONS FOR OTC DRUG PRODUCT LIST

 

        LOPERAMIDE HYDROCHLORIDE
>D>       SOLUTION; ORAL
>D>         IMODIUM A-D
>D>       +   MCNEIL                     1MG/7.5ML                               N19487 002  Jul 08, 2004    Mar  CDFR
>A>       SUSPENSION; ORAL
>A>         IMODIUM A-D
>A>       +   MCNEIL                     1MG/7.5ML                               N19487 002  Jul 08, 2004    Mar  CDFR

        NICOTINE POLACRILEX
          GUM, CHEWING; BUCCAL
            NICORETTE
>A>           GLAXOSMITHKLINE            EQ 2MG BASE                             N18612 003  Dec 23, 1998    Mar  CRLD
>A>                                      EQ 2MG BASE                             N18612 004  Sep 25, 2000    Mar  CRLD
>A>                                      EQ 4MG BASE                             N20066 003  Dec 23, 1998    Mar  CRLD
>A>                                      EQ 4MG BASE                             N20066 004  Sep 25, 2000    Mar  CRLD
            NICORETTE (MINT)
>D>       +   GLAXOSMITHKLINE            EQ 2MG BASE                             N18612 003  Dec 23, 1998    Mar  CRLD
>D>       +                              EQ 4MG BASE                             N20066 003  Dec 23, 1998    Mar  CRLD
            NICORETTE (ORANGE)
>D>       +   GLAXOSMITHKLINE            EQ 2MG BASE                             N18612 004  Sep 25, 2000    Mar  CRLD
>D>       +                              EQ 4MG BASE                             N20066 004  Sep 25, 2000    Mar  CRLD

Date created: April 14, 2006

horizonal rule