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U.S. Department of Health and Human Services

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December 2007: Additions and Deletions to the Drug Product List

27th Edition: Cumulative Supplement Number 12

Prescription     OTC

NOTE: The format for the Monthly Additions/Deletions Drug Product List changed as of the July Cumulative Supplement (CS) of the 21st Edition to mirror the CS. Refer to the CS Preface section 1.6 Cumulative Supplement Legend.


ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST
 
        ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
          SOLUTION; INHALATION
            ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
>A>   AN      APOTEX CORP                EQ 0.083% BASE;0.017%                   N77117 001  Dec 31, 2007    Dec  NEWA
>A>   AN      BREATH LTD                 EQ 0.083% BASE;0.017%                   N77063 001  Dec 31, 2007    Dec  NEWA
>A>   AN      IVAX PHARMS INC            EQ 0.083% BASE;0.017%                   N76724 001  Dec 31, 2007    Dec  NEWA
>A>   AN      NEPHRON                    EQ 0.083% BASE;0.017%                   N76749 001  Dec 31, 2007    Dec  NEWA
>A>   AN      WATSON LABS                EQ 0.083% BASE;0.017%                   N77559 001  Dec 31, 2007    Dec  NEWA

        BALSALAZIDE DISODIUM
          CAPSULE; ORAL
>A>         BALSALAZIDE DISODIUM
>A>   AB      APOTEX INC                 750MG                                   N77883 001  Dec 28, 2007    Dec  NEWA
>A>   AB      MYLAN                      750MG                                   N77807 001  Dec 28, 2007    Dec  NEWA
>A>   AB      ROXANE                     750MG                                   N77806 001  Dec 28, 2007    Dec  NEWA
            COLAZAL
>D>       +   SALIX PHARMS               750MG                                   N20610 001  Jul 18, 2000    Dec  CFTG
>A>   AB  +                              750MG                                   N20610 001  Jul 18, 2000    Dec  CFTG


        BLEOMYCIN SULFATE
          INJECTABLE; INJECTION
            BLEOMYCIN
>A>   AP      PHARMACHEMIE BV            EQ 15 UNITS BASE/VIAL                   N65201 001  Dec 13, 2007    Dec  NEWA

        BUPIVACAINE HYDROCHLORIDE
          INJECTABLE; INJECTION
            SENSORCAINE
>D>   AP      ABRAXIS                    0.25%                                   N18304 001                  Dec  CAHN
>D>   AP                                 0.5%                                    N18304 002                  Dec  CAHN
>D>   AP                                 0.75%                                   N18304 003                  Dec  CAHN
>A>   AP      APP PHARMS                 0.25%                                   N18304 001                  Dec  CAHN
>A>   AP                                 0.5%                                    N18304 002                  Dec  CAHN
>A>   AP                                 0.75%                                   N18304 003                  Dec  CAHN

        BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
          INJECTABLE; INJECTION
            SENSORCAINE
>D>   AP      ABRAXIS                    0.5%;0.0091MG/ML                        N18304 004  Sep 02, 1983    Dec  CAHN
>D>   AP                                 0.75%;0.0091MG/ML                       N18304 005  Sep 02, 1983    Dec  CAHN
>A>   AP      APP PHARMS                 0.5%;0.0091MG/ML                        N18304 004  Sep 02, 1983    Dec  CAHN
>A>   AP                                 0.75%;0.0091MG/ML                       N18304 005  Sep 02, 1983    Dec  CAHN


        BUSPIRONE HYDROCHLORIDE
          TABLET; ORAL
            BUSPIRONE HYDROCHLORIDE
>A>   AB      ACTAVIS TOTOWA             30MG                                    N78302 001  Dec 17, 2007    Dec  NEWA

        CARBOPLATIN
          INJECTABLE; IV (INFUSION)
            CARBOPLATIN
>A>   AP  +   PHARMACHEMIE               EQ 600MG/60ML (10MG/ML)                 N77269 004  Dec 28, 2007    Dec  CRLD

        CEFDINIR
          CAPSULE; ORAL
            CEFDINIR
>A>   AB      AUROBINDO                  300MG                                   N65434 001  Jan 07, 2008    Dec  NEWA
          FOR SUSPENSION; ORAL
            CEFDINIR
>A>   AB      AUROBINDO                  125MG/5ML                               N65473 001  Dec 14, 2007    Dec  NEWA
>A>   AB                                 250MG/5ML                               N65473 002  Dec 14, 2007    Dec  NEWA

        CEFTRIAXONE
          INJECTABLE; IM-IV
            CEFTRIAXONE
>A>   AP      HIKMA                      EQ 250MG BASE/VIAL                      N65342 001  Jan 10, 2008    Dec  NEWA
>A>   AP                                 EQ 500MG BASE/VIAL                      N65342 002  Jan 10, 2008    Dec  NEWA
>A>   AP                                 EQ 1GM BASE/VIAL                        N65342 003  Jan 10, 2008    Dec  NEWA
>A>   AP                                 EQ 2GM BASE/VIAL                        N65342 004  Jan 10, 2008    Dec  NEWA

        CEPHALEXIN
          CAPSULE; ORAL
            CEPHALEXIN
>D>   AB      APOTHECON                  EQ 250MG BASE                           N63063 001  Sep 29, 1989    Dec  DISC
>A>         @                            EQ 250MG BASE                           N63063 001  Sep 29, 1989    Dec  DISC
>D>   AB                                 EQ 500MG BASE                           N63063 002  Sep 29, 1989    Dec  DISC
>A>         @                            EQ 500MG BASE                           N63063 002  Sep 29, 1989    Dec  DISC


        CHLOROPROCAINE HYDROCHLORIDE
          INJECTABLE; INJECTION
            NESACAINE
>D>       +   ABRAXIS                    1%                                      N09435 001                  Dec  CAHN
>D>   AP                                 2%                                      N09435 002                  Dec  CAHN
>A>       +   APP PHARMS                 1%                                      N09435 001                  Dec  CAHN
>A>   AP                                 2%                                      N09435 002                  Dec  CAHN
            NESACAINE-MPF
>D>         @ ABRAXIS                    2%                                      N09435 003                  Dec  CAHN
>D>   AP  +                              2%                                      N09435 006  May 02, 1996    Dec  CAHN
>D>         @                            3%                                      N09435 004                  Dec  CAHN
>D>   AP  +                              3%                                      N09435 007  May 02, 1996    Dec  CAHN
>A>         @ APP PHARMS                 2%                                      N09435 003                  Dec  CAHN
>A>   AP  +                              2%                                      N09435 006  May 02, 1996    Dec  CAHN
>A>         @                            3%                                      N09435 004                  Dec  CAHN
>A>   AP  +                              3%                                      N09435 007  May 02, 1996    Dec  CAHN

        CICLESONIDE
          SPRAY, METERED; NASAL
            OMNARIS
>D>       +   ALTANA PHARMA              0.05MG/INH                              N22004 001  Oct 20, 2006    Dec  CAHN
>A>       +   NYCOMED US                 0.05MG/INH                              N22004 001  Oct 20, 2006    Dec  CAHN

        CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
          TABLET, EXTENDED RELEASE; ORAL
            CIPROFLOXACIN EXTENDED RELEASE
>A>   AB      SANDOZ                     212.6MG;EQ 287.5MG BASE                 N78712 001  Dec 11, 2007    Dec  NEWA


        DICLOFENAC SODIUM
          SOLUTION/DROPS; OPHTHALMIC
>A>         DICLOFENAC SODIUM
>A>   AT      BAUSCH AND LOMB            0.1%                                    N78792 001  Dec 28, 2007    Dec  NEWA
>A>   AT      NEXUS PHARMS               0.1%                                    N78553 001  Dec 28, 2007    Dec  NEWA
            VOLTAREN
>D>       +   NOVARTIS                   0.1%                                    N20037 001  Mar 28, 1991    Dec  CFTG
>A>   AT  +                              0.1%                                    N20037 001  Mar 28, 1991    Dec  CFTG

        DILTIAZEM HYDROCHLORIDE
          CAPSULE, EXTENDED RELEASE; ORAL
            CARDIZEM CD
>D>   AB3     BIOVAIL                    120MG                                   N20062 001  Aug 10, 1992    Dec  CAHN
>A>   AB3                                120MG                                   N20062 001  Aug 10, 1992    Dec  CAHN
>D>   AB3                                180MG                                   N20062 002  Dec 27, 1991    Dec  CAHN
>A>   AB3                                180MG                                   N20062 002  Dec 27, 1991    Dec  CAHN
>D>   AB3                                240MG                                   N20062 003  Dec 27, 1991    Dec  CAHN
>A>   AB3                                240MG                                   N20062 003  Dec 27, 1991    Dec  CAHN
>D>   AB3                                300MG                                   N20062 004  Dec 27, 1991    Dec  CRLD
>A>   AB3 +                              300MG                                   N20062 004  Dec 27, 1991    Dec  CRLD
>D>   BC  +                              360MG                                   N20062 005  Aug 24, 1999    Dec  CAHN
>A>   BC  +                              360MG                                   N20062 005  Aug 24, 1999    Dec  CAHN
            DILTIAZEM HYDROCHLORIDE
>D>   AB3     BIOVAIL                    120MG                                   N20939 001  Jan 28, 2000    Dec  DISC
>A>         @                            120MG                                   N20939 001  Jan 28, 2000    Dec  DISC
>D>   AB3                                180MG                                   N20939 002  Jan 28, 2000    Dec  DISC
>A>         @                            180MG                                   N20939 002  Jan 28, 2000    Dec  DISC
>D>   AB3                                240MG                                   N20939 003  Jan 28, 2000    Dec  DISC
>A>         @                            240MG                                   N20939 003  Jan 28, 2000    Dec  DISC
>D>   AB3                                300MG                                   N20939 004  Jan 28, 2000    Dec  DISC
>A>         @                            300MG                                   N20939 004  Jan 28, 2000    Dec  DISC
>A>         @                            360MG                                   N20939 005  Sep 14, 2001    Dec  DISC
>A>         @                            420MG                                   N20939 006  Sep 14, 2001    Dec  DISC
          INJECTABLE; INJECTION
>D>         CARDIZEM
>D>   AP  +   BIOVAIL                    100MG/VIAL                              N20792 001  Sep 05, 1997    Dec  DISC
>A>         @                            100MG/VIAL                              N20792 001  Sep 05, 1997    Dec  DISC
            DILTIAZEM HYDROCHLORIDE
>D>   AP      HOSPIRA                    100MG/VIAL                              N75853 001  Dec 17, 2002    Dec  CRLD
>A>       +                              100MG/VIAL                              N75853 001  Dec 17, 2002    Dec  CRLD

        EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
          INJECTABLE; INJECTION
            XYLOCAINE W/ EPINEPHRINE
>D>   AP  +   ABRAXIS                    0.005MG/ML;0.5%                         N06488 012                  Dec  CAHN
>D>   AP  +                              0.005MG/ML;1%                           N06488 018  Nov 13, 1986    Dec  CAHN
>D>   AP  +                              0.005MG/ML;1.5%                         N06488 017                  Dec  CAHN
>D>   AP  +                              0.005MG/ML;2%                           N06488 019  Nov 13, 1986    Dec  CAHN
>D>   AP  +                              0.01MG/ML;1%                            N06488 004                  Dec  CAHN
>D>         @                            0.01MG/ML;2%                            N06488 003                  Dec  CAHN
>D>         @                            0.02MG/ML;2%                            N06488 005                  Dec  CAHN
>A>   AP  +   APP PHARMS                 0.005MG/ML;0.5%                         N06488 012                  Dec  CAHN
>A>   AP  +                              0.005MG/ML;1%                           N06488 018  Nov 13, 1986    Dec  CAHN
>A>   AP  +                              0.005MG/ML;1.5%                         N06488 017                  Dec  CAHN
>A>   AP  +                              0.005MG/ML;2%                           N06488 019  Nov 13, 1986    Dec  CAHN
>A>   AP  +                              0.01MG/ML;1%                            N06488 004                  Dec  CAHN
>A>         @                            0.01MG/ML;2%                            N06488 003                  Dec  CAHN
>A>         @                            0.02MG/ML;2%                            N06488 005                  Dec  CAHN


        ETOPOSIDE
          INJECTABLE; INJECTION
            ETOPOSIDE
>A>   AP      ACCORD HLTHCARE            20MG/ML                                 N74513 001  Mar 14, 1996    Dec  CAHN
>D>   AP      SUPERGEN                   20MG/ML                                 N74513 001  Mar 14, 1996    Dec  CAHN

        FENOFIBRATE
          TABLET; ORAL
            TRIGLIDE
>D>   BX      SKYEPHARMA AG              160MG                                   N21350 002  May 07, 2005    Dec  CRLD
>A>   BX  +                              160MG                                   N21350 002  May 07, 2005    Dec  CRLD

        FLUVOXAMINE MALEATE
          TABLET; ORAL
>A>         LUVOX
>A>   AB      SOLVAY                     25MG                                    N21519 001  Dec 20, 2007    Dec  NEWA
>A>   AB                                 50MG                                    N21519 002  Dec 20, 2007    Dec  NEWA
>A>   AB                                 100MG                                   N21519 003  Dec 20, 2007    Dec  NEWA


        FOMEPIZOLE
          INJECTABLE; INJECTION
            ANTIZOL
>D>       +   JAZZ                       1GM/ML                                  N20696 001  Dec 04, 1997    Dec  CFTG
>A>   AP  +                              1.5GM/1.5ML (1GM/ML)                    N20696 001  Dec 04, 1997    Dec  CFTG
>A>         FOMEPIZOLE
>A>   AP      PHARMAFORCE                1.5GM/1.5ML (1GM/ML)                    N78368 001  Dec 14, 2007    Dec  NEWA

        GLIMEPIRIDE; ROSIGLITAZONE MALEATE
          TABLET; ORAL
            AVANDARYL
>A>           SB PHARMCO                 2MG;8MG                                 N21700 004  Mar 30, 2007    Dec  NEWA
>A>                                      4MG;8MG                                 N21700 005  Mar 30, 2007    Dec  NEWA


        GONADOTROPIN, CHORIONIC
          INJECTABLE; INJECTION
            CHORIONIC GONADOTROPIN
>D>         @ ABRAXIS PHARM              5,000 UNITS/VIAL                        N17067 001                  Dec  CAHN
>D>   AP  +                              10,000 UNITS/VIAL                       N17067 002                  Dec  CAHN
>D>         @                            15,000 UNITS/VIAL                       N17067 004                  Dec  CAHN
>D>         @                            20,000 UNITS/VIAL                       N17067 003                  Dec  CAHN
>A>         @ APP PHARMS                 5,000 UNITS/VIAL                        N17067 001                  Dec  CAHN
>A>   AP  +                              10,000 UNITS/VIAL                       N17067 002                  Dec  CAHN
>A>         @                            15,000 UNITS/VIAL                       N17067 004                  Dec  CAHN
>A>         @                            20,000 UNITS/VIAL                       N17067 003                  Dec  CAHN

        GRANISETRON HYDROCHLORIDE
          INJECTABLE; INJECTION
>A>         GRANISETRON HYDROCHLORIDE
>A>   AP      APOTEX CORP                EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)     N78197 001  Dec 31, 2007    Dec  NEWA
>A>   AP      APP PHARMS                 EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)     N78522 001  Dec 31, 2007    Dec  NEWA
>A>   AP      BAXTER HLTHCARE            EQ 4MG BASE/4ML (EQ 1MG BASE/ML)        N77177 001  Dec 31, 2007    Dec  NEWA
>A>   AP      TEVA PARENTERAL            EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)     N78392 001  Dec 31, 2007    Dec  NEWA
>A>   AP                                 EQ 1MG BASE/ML (EQ 1MG BASE/ML)         N77963 001  Jan 03, 2008    Dec  NEWA
>A>   AP      WATSON LABS                EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)     N78262 001  Dec 31, 2007    Dec  NEWA
>A>         GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
>A>   AP      TEVA PARENTERAL            EQ 1MG BASE/ML (EQ 1MG BASE/ML)         N77165 001  Dec 31, 2007    Dec  NEWA
            KYTRIL
>D>       +   ROCHE                      EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)     N20239 003  Sep 17, 2004    Dec  CFTG
>A>   AP  +                              EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)     N20239 003  Sep 17, 2004    Dec  CFTG
>D>       +                              EQ 1MG BASE/ML (EQ 1MG BASE/ML)         N20239 004  Mar 11, 1994    Dec  CFTG
>A>   AP  +                              EQ 1MG BASE/ML (EQ 1MG BASE/ML)         N20239 004  Mar 11, 1994    Dec  CFTG
>D>       +                              EQ 4MG BASE/4ML (EQ 1MG BASE/ML)        N20239 002  Mar 11, 1994    Dec  CFTG
>A>   AP  +                              EQ 4MG BASE/4ML (EQ 1MG BASE/ML)        N20239 002  Mar 11, 1994    Dec  CFTG
          TABLET; ORAL
>A>         GRANISETRON HYDROCHLORIDE
>A>   AB      BARR                       EQ 1MG BASE                             N78221 001  Dec 31, 2007    Dec  NEWA
>A>   AB      COREPHARMA                 EQ 1MG BASE                             N78260 001  Dec 31, 2007    Dec  NEWA
>A>   AB      ROXANE                     EQ 1MG BASE                             N77842 001  Dec 31, 2007    Dec  NEWA
>A>   AB      TEVA PHARMS                EQ 1MG BASE                             N78080 001  Dec 31, 2007    Dec  NEWA
            KYTRIL
>D>       +   ROCHE                      EQ 1MG BASE                             N20305 001  Mar 16, 1995    Dec  CFTG
>A>   AB  +                              EQ 1MG BASE                             N20305 001  Mar 16, 1995    Dec  CFTG


        HEPARIN SODIUM
          INJECTABLE; INJECTION
            HEPARIN SODIUM
>D>         @ ABRAXIS PHARM              1,000 UNITS/ML                          N17651 005                  Dec  CAHN
>D>   AP                                 1,000 UNITS/ML                          N17029 001                  Dec  CAHN
>D>   AP                                 5,000 UNITS/ML                          N17651 006                  Dec  CAHN
>D>         @                            5,000 UNITS/ML                          N17029 002                  Dec  CAHN
>D>         @                            10,000 UNITS/ML                         N17651 003                  Dec  CAHN
>D>   AP                                 10,000 UNITS/ML                         N17029 003                  Dec  CAHN
>D>         @                            20,000 UNITS/ML                         N17651 008                  Dec  CAHN
>D>   AP  +                              20,000 UNITS/ML                         N17029 004                  Dec  CAHN
>A>         @ APP PHARMS                 1,000 UNITS/ML                          N17651 005                  Dec  CAHN
>A>   AP                                 1,000 UNITS/ML                          N17029 001                  Dec  CAHN
>A>   AP                                 5,000 UNITS/ML                          N17651 006                  Dec  CAHN
>A>         @                            5,000 UNITS/ML                          N17029 002                  Dec  CAHN
>A>         @                            10,000 UNITS/ML                         N17651 003                  Dec  CAHN
>A>   AP                                 10,000 UNITS/ML                         N17029 003                  Dec  CAHN
>A>         @                            20,000 UNITS/ML                         N17651 008                  Dec  CAHN
>A>   AP  +                              20,000 UNITS/ML                         N17029 004                  Dec  CAHN
>D>   AP  +   BAXTER HLTHCARE            5,000 UNITS/0.5ML                       N17037 013  Apr 07, 1986    Dec  DISC
>A>         @                            5,000 UNITS/0.5ML                       N17037 013  Apr 07, 1986    Dec  DISC
            HEPARIN SODIUM IN PLASTIC CONTAINER
>D>   AP      ABRAXIS PHARM              1,000 UNITS/ML                          N17029 013  Dec 05, 1985    Dec  CAHN
>D>   AP                                 5,000 UNITS/ML                          N17029 014  Dec 05, 1985    Dec  CAHN
>D>   AP                                 10,000 UNITS/ML                         N17029 015  Dec 05, 1985    Dec  CAHN
>D>   AP                                 20,000 UNITS/ML                         N17029 016  Dec 05, 1985    Dec  CAHN
>A>   AP      APP PHARMS                 1,000 UNITS/ML                          N17029 013  Dec 05, 1985    Dec  CAHN
>A>   AP                                 5,000 UNITS/ML                          N17029 014  Dec 05, 1985    Dec  CAHN
>A>   AP                                 10,000 UNITS/ML                         N17029 015  Dec 05, 1985    Dec  CAHN
>A>   AP                                 20,000 UNITS/ML                         N17029 016  Dec 05, 1985    Dec  CAHN
            HEPARIN SODIUM PRESERVATIVE FREE
>D>   AP  +   ABRAXIS PHARM              1,000 UNITS/ML                          N17029 010  Apr 28, 1986    Dec  CAHN
>A>   AP  +   APP PHARMS                 1,000 UNITS/ML                          N17029 010  Apr 28, 1986    Dec  CAHN

        IBUPROFEN; OXYCODONE HYDROCHLORIDE
          TABLET; ORAL
            OXYCODONE HYDROCHLORIDE AND IBUPROFEN
>A>   AB      ACTAVIS ELIZABETH          400MG;5MG                               N78769 001  Jan 04, 2008    Dec  NEWA


        IRINOTECAN HYDROCHLORIDE
          INJECTABLE; INJECTION
            CAMPTOSAR
>A>       +   PFIZER INC                 20MG/ML                                 N20571 001  Jun 14, 1996    Dec  CAHN
>D>       +   PHARMACIA AND              20MG/ML                                 N20571 001  Jun 14, 1996    Dec  CAHN

        ISOSORBIDE DINITRATE
          TABLET; SUBLINGUAL
>D>         ISORDIL
>D>   AB      BIOVAIL                    2.5MG                                   N12940 004  Jul 29, 1988    Dec  DISC
>A>         @                            2.5MG                                   N12940 004  Jul 29, 1988    Dec  DISC
>D>   AB                                 5MG                                     N12940 003  Jul 29, 1988    Dec  DISC
>A>         @                            5MG                                     N12940 003  Jul 29, 1988    Dec  DISC
>D>       +                              10MG                                    N12940 005  Jul 29, 1988    Dec  DISC
>A>         @                            10MG                                    N12940 005  Jul 29, 1988    Dec  DISC

        LABETALOL HYDROCHLORIDE
          INJECTABLE; INJECTION
            LABETALOL HYDROCHLORIDE
>D>   AP      HOSPIRA                    5MG/ML                                  N75240 001  Nov 29, 1999    Dec  CRLD
>A>   AP  +                              5MG/ML                                  N75240 001  Nov 29, 1999    Dec  CRLD
>D>   AP                                 5MG/ML                                  N75239 001  Nov 29, 1999    Dec  CRLD
>A>   AP  +                              5MG/ML                                  N75239 001  Nov 29, 1999    Dec  CRLD


        LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE
          INJECTABLE; INJECTION
>D>         CARBOCAINE W/ NEO-COBEFRIN
>D>   AP  +   EASTMAN KODAK              0.05MG/ML;2%                            N12125 002                  Dec  DISC
>A>         @                            0.05MG/ML;2%                            N12125 002                  Dec  DISC

        LEVONORGESTREL
          TABLET; ORAL
            PLAN B
>D>       +   DURAMED                    0.75MG                                  N21045 001  Jul 28, 1999    Dec  DISC
>A>         @                            0.75MG                                  N21045 001  Jul 28, 1999    Dec  DISC


        LIDOCAINE HYDROCHLORIDE
          INJECTABLE; INJECTION
            XYLOCAINE
>D>   AP  +   ABRAXIS                    0.5%                                    N06488 008                  Dec  CAHN
>D>   AP  +                              1%                                      N06488 007                  Dec  CAHN
>D>   AP  +                              1.5%                                    N06488 010                  Dec  CAHN
>D>         @                            2%                                      N06488 002                  Dec  CAHN
>A>   AP  +   APP PHARMS                 0.5%                                    N06488 008                  Dec  CAHN
>A>   AP  +                              1%                                      N06488 007                  Dec  CAHN
>A>   AP  +                              1.5%                                    N06488 010                  Dec  CAHN
>A>         @                            2%                                      N06488 002                  Dec  CAHN
            XYLOCAINE 4% PRESERVATIVE FREE
>D>   AP  +   ABRAXIS                    4%                                      N10417 001                  Dec  CAHN
>A>   AP  +   APP PHARMS                 4%                                      N10417 001                  Dec  CAHN
          INJECTABLE; SPINAL
            XYLOCAINE 1.5% W/ DEXTROSE 7.5%
>D>         @ ABRAXIS                    1.5%                                    N16297 001                  Dec  CAHN
>A>         @ APP PHARMS                 1.5%                                    N16297 001                  Dec  CAHN
          JELLY; TOPICAL
            XYLOCAINE
>D>   AT  +   ABRAXIS                    2%                                      N08816 001                  Dec  CAHN
>A>   AT  +   APP PHARMS                 2%                                      N08816 001                  Dec  CAHN
          SOLUTION; ORAL
            XYLOCAINE VISCOUS
>D>   AT  +   ABRAXIS                    2%                                      N09470 001                  Dec  CAHN
>A>   AT  +   APP PHARMS                 2%                                      N09470 001                  Dec  CAHN
          SOLUTION; TOPICAL
            XYLOCAINE 4% PRESERVATIVE FREE
>D>   AT  +   ABRAXIS                    4%                                      N10417 002                  Dec  CAHN
>A>   AT  +   APP PHARMS                 4%                                      N10417 002                  Dec  CAHN

        LIDOCAINE; PRILOCAINE
          CREAM; TOPICAL
            EMLA
>D>   AB  +   ABRAXIS                    2.5%;2.5%                               N19941 001  Dec 30, 1992    Dec  CAHN
>A>   AB  +   APP PHARMS                 2.5%;2.5%                               N19941 001  Dec 30, 1992    Dec  CAHN


        LISDEXAMFETAMINE DIMESYLATE
          CAPSULE; ORAL
            VYVANSE
>A>           NEW RIVER PHARMS           20MG                                    N21977 004  Dec 10, 2007    Dec  NEWA
>A>                                      30MG                                    N21977 001  Feb 23, 2007    Dec  CAHN
>A>                                      40MG                                    N21977 005  Dec 10, 2007    Dec  NEWA
>A>                                      50MG                                    N21977 002  Feb 23, 2007    Dec  CAHN
>A>                                      60MG                                    N21977 006  Dec 10, 2007    Dec  NEWA
>A>       +                              70MG                                    N21977 003  Feb 23, 2007    Dec  CAHN
>D>           SHIRE                      30MG                                    N21977 001  Feb 23, 2007    Dec  CAHN
>D>                                      50MG                                    N21977 002  Feb 23, 2007    Dec  CAHN
>D>       +                              70MG                                    N21977 003  Feb 23, 2007    Dec  CAHN

        MEPIVACAINE HYDROCHLORIDE
          INJECTABLE; INJECTION
            CARBOCAINE
>D>   AP  +   EASTMAN KODAK              3%                                      N12125 003                  Dec  DISC
>A>         @                            3%                                      N12125 003                  Dec  DISC
            ISOCAINE HYDROCHLORIDE
>D>   AP      NOVOCOL                    3%                                      N80925 001                  Dec  CRLD
>A>   AP  +                              3%                                      N80925 001                  Dec  CRLD
            SCANDONEST PLAIN
>D>   AP      DEPROCO                    3%                                      N88387 001  Oct 10, 1984    Dec  CRLD
>A>   AP  +                              3%                                      N88387 001  Oct 10, 1984    Dec  CRLD

        METFORMIN HYDROCHLORIDE
          TABLET, EXTENDED RELEASE; ORAL
            METFORMIN HYDROCHLORIDE
>A>   AB      INTERPHARM                 500MG                                   N78596 001  Jan 03, 2008    Dec  NEWA
>A>   AB                                 750MG                                   N78596 002  Jan 03, 2008    Dec  NEWA


        METHIMAZOLE
          TABLET; ORAL
            METHIMAZOLE
>A>   AB      ACTAVIS TOTOWA             5MG                                     N40734 001  Dec 14, 2007    Dec  NEWA
>A>   AB                                 10MG                                    N40734 002  Dec 14, 2007    Dec  NEWA


        METRONIDAZOLE
          CREAM; TOPICAL
            METRONIDAZOLE
>A>   AB      G AND W LABS               0.75%                                   N77549 001  Dec 19, 2007    Dec  NEWA

        MINOCYCLINE HYDROCHLORIDE
          TABLET; ORAL
            MINOCYCLINE HYDROCHLORIDE
>A>   AB      INDICUS PHARMA             EQ 50MG BASE                            N65436 001  Dec 26, 2007    Dec  NEWA
>A>   AB                                 EQ 75MG BASE                            N65436 002  Dec 26, 2007    Dec  NEWA
>A>   AB                                 EQ 100MG BASE                           N65436 003  Dec 26, 2007    Dec  NEWA


>A>     NEBIVOLOL HYDROCHLORIDE
>A>       TABLET; ORAL
>A>         BYSTOLIC
>A>           MYLAN BERTEK               EQ 2.5MG BASE                           N21742 002  Dec 17, 2007    Dec  NEWA
>A>                                      EQ 5MG BASE                             N21742 003  Dec 17, 2007    Dec  NEWA
>A>       +                              EQ 10MG BASE                            N21742 004  Dec 17, 2007    Dec  NEWA

        NYSTATIN
          CREAM; TOPICAL
            MYCOSTATIN
>A>   AT  +   BRISTOL MYERS              100,000 UNITS/GM                        N60575 001                  Dec  CAHN
>D>   AT  +   RANBAXY                    100,000 UNITS/GM                        N60575 001                  Dec  CAHN
          POWDER; TOPICAL
            MYCOSTATIN
>A>   AT  +   BRISTOL MYERS              100,000 UNITS/GM                        N60578 001                  Dec  CAHN
>D>   AT  +   RANBAXY                    100,000 UNITS/GM                        N60578 001                  Dec  CAHN
          TABLET; ORAL
>D>         MYCOSTATIN
>D>   AA  +   APOTHECON                  500,000 UNITS                           N60574 001                  Dec  DISC
>A>         @ BRISTOL MYERS              500,000 UNITS                           N60574 001                  Dec  DISC

        OCTREOTIDE ACETATE
          INJECTABLE; INJECTION
            OCTREOTIDE ACETATE (PRESERVATIVE FREE)
>D>   AP      BEDFORD                    EQ 0.05MG BASE/ML                       N76313 001  Mar 28, 2005    Dec  CRLD
>A>   AP  +                              EQ 0.05MG BASE/ML                       N76313 001  Mar 28, 2005    Dec  CRLD
>D>   AP                                 EQ 0.1MG BASE/ML                        N76313 003  Mar 28, 2005    Dec  CRLD
>A>   AP  +                              EQ 0.1MG BASE/ML                        N76313 003  Mar 28, 2005    Dec  CRLD
>D>   AP                                 EQ 0.5MG BASE/ML                        N76313 002  Mar 28, 2005    Dec  CRLD
>A>   AP  +                              EQ 0.5MG BASE/ML                        N76313 002  Mar 28, 2005    Dec  CRLD


        OXCARBAZEPINE
          TABLET; ORAL
            OXCARBAZEPINE
>A>   AB      BRECKENRIDGE               150MG                                   N78069 001  Jan 11, 2008    Dec  NEWA
>A>   AB                                 300MG                                   N78069 002  Jan 11, 2008    Dec  NEWA
>A>   AB                                 600MG                                   N78069 003  Jan 11, 2008    Dec  NEWA
>A>   AB      TEVA PHARMS                150MG                                   N78005 001  Dec 11, 2007    Dec  NEWA
>A>   AB                                 300MG                                   N78005 002  Dec 11, 2007    Dec  NEWA
>A>   AB                                 600MG                                   N78005 003  Dec 11, 2007    Dec  NEWA

        OXYTOCIN
          INJECTABLE; INJECTION
            OXYTOCIN
>D>   AP  +   ABRAXIS PHARM              10USP UNITS/ML (10USP UNITS/ML)         N18248 001                  Dec  CAHN
>D>       +                              100USP UNITS/10 ML (10USP UNITS/ML)     N18248 002                  Dec  CAHN
>D>       +                              300USP UNITS/30 ML (10USP UNITS/ML)     N18248 003  Jul 27, 2007    Dec  CAHN
>A>   AP  +   APP PHARMS                 10USP UNITS/ML (10USP UNITS/ML)         N18248 001                  Dec  CAHN
>A>       +                              100USP UNITS/10 ML (10USP UNITS/ML)     N18248 002                  Dec  CAHN
>A>       +                              300USP UNITS/30 ML (10USP UNITS/ML)     N18248 003  Jul 27, 2007    Dec  CAHN
>D>         @ BAXTER HLTHCARE            10USP UNITS/ML                          N18243 001                  Dec  CMFD
>A>   AP  +                              10USP UNITS/ML (10USP UNITS/ML)         N18243 001                  Dec  CMFD

        PACLITAXEL
          INJECTABLE; INJECTION
            PACLITAXEL
>A>   AP      EBEWE PHARMA               6MG/ML                                  N78167 001  Dec 26, 2007    Dec  NEWA


        PAROMOMYCIN SULFATE
          CAPSULE; ORAL
            PAROMOMYCIN SULFATE
>A>   AA      X-GEN PHARMS               EQ 250MG BASE                           N65173 001  Dec 14, 2007    Dec  NEWA


        PENTAMIDINE ISETHIONATE
          FOR SOLUTION; INHALATION
            NEBUPENT
>D>       +   ABRAXIS PHARM              300MG/VIAL                              N19887 001  Jun 15, 1989    Dec  CAHN
>D>                                      600MG/VIAL                              N19887 002  Mar 22, 1996    Dec  CAHN
>A>       +   APP PHARMS                 300MG/VIAL                              N19887 001  Jun 15, 1989    Dec  CAHN
>A>                                      600MG/VIAL                              N19887 002  Mar 22, 1996    Dec  CAHN
          INJECTABLE; INJECTION
            PENTAM
>D>   AP  +   ABRAXIS PHARM              300MG/VIAL                              N19264 001  Oct 16, 1984    Dec  CAHN
>A>   AP  +   APP PHARMS                 300MG/VIAL                              N19264 001  Oct 16, 1984    Dec  CAHN

        PHENTERMINE HYDROCHLORIDE
          CAPSULE; ORAL
            PHENTERMINE HYDROCHLORIDE
>D>         @ LANNETT                    30MG                                    N87022 001  Feb 03, 1983    Dec  CMFD
>A>   AA                                 30MG                                    N87022 001  Feb 03, 1983    Dec  CMFD


        PHENYTOIN SODIUM
          CAPSULE; ORAL
            DILANTIN
>D>       +   PARKE DAVIS                30MG EXTENDED                           N84349 001                  Dec  CTEC
>A>   AB  +                              30MG EXTENDED                           N84349 001                  Dec  CTEC
            EXTENDED PHENYTOIN SODIUM
>A>   AB      WOCKHARDT                  30MG EXTENDED                           N40759 001  Dec 18, 2007    Dec  NEWA

        POLYMYXIN B SULFATE
          INJECTABLE; INJECTION
            POLYMXIN B SULFATE
>A>   AP      ABRAXIS PHARM              EQ 500,000 U BASE/VIAL                  N65372 001  Jan 10, 2008    Dec  NEWA

        PRAVASTATIN SODIUM
          TABLET; ORAL
            PRAVASTATIN SODIUM
>A>   AB      APOTEX                     80MG                                    N76341 004  Dec 28, 2007    Dec  NEWA
>D>   AB      COBALT                     10MG                                    N76939 004  Oct 23, 2006    Dec  CAHN
>D>   AB                                 20MG                                    N76939 003  Oct 23, 2006    Dec  CAHN
>D>   AB                                 40MG                                    N76939 002  Oct 23, 2006    Dec  CAHN
>A>   AB      COBALT LABS INC            10MG                                    N76939 004  Oct 23, 2006    Dec  CAHN
>A>   AB                                 20MG                                    N76939 003  Oct 23, 2006    Dec  CAHN
>A>   AB                                 40MG                                    N76939 002  Oct 23, 2006    Dec  CAHN
>A>   AB                                 80MG                                    N76939 001  Dec 28, 2007    Dec  NEWA
>A>   AB      DR REDDYS LABS INC         80MG                                    N76714 004  Dec 28, 2007    Dec  NEWA
>A>   AB      GENPHARM                   80MG                                    N77013 004  Dec 28, 2007    Dec  NEWA
>A>   AB      GLENMARK PHARMS            80MG                                    N77987 004  Dec 28, 2007    Dec  NEWA
>A>   AB      LUPIN PHARMS               10MG                                    N77917 001  Jan 08, 2008    Dec  NEWA
>A>   AB                                 20MG                                    N77917 002  Jan 08, 2008    Dec  NEWA
>A>   AB                                 40MG                                    N77917 003  Jan 08, 2008    Dec  NEWA
>A>   AB                                 80MG                                    N77917 004  Jan 08, 2008    Dec  NEWA


        PROPRANOLOL HYDROCHLORIDE
          TABLET; ORAL
            PROPRANOLOL HYDROCHLORIDE
>A>   AB      NORTHSTAR                  10MG                                    N78213 001  Jan 10, 2008    Dec  NEWA
>A>   AB                                 20MG                                    N78213 002  Jan 10, 2008    Dec  NEWA
>A>   AB                                 40MG                                    N78213 003  Jan 10, 2008    Dec  NEWA
>A>   AB                                 60MG                                    N78213 004  Jan 10, 2008    Dec  NEWA
>A>   AB                                 80MG                                    N78213 005  Jan 10, 2008    Dec  NEWA


        RAMIPRIL
          CAPSULE; ORAL
            ALTACE
>D>           KING PHARMS                1.25MG                                  N19901 001  Jan 28, 1991    Dec  CTEC
>A>   AB                                 1.25MG                                  N19901 001  Jan 28, 1991    Dec  CTEC
>D>                                      2.5MG                                   N19901 002  Jan 28, 1991    Dec  CTEC
>A>   AB                                 2.5MG                                   N19901 002  Jan 28, 1991    Dec  CTEC
>D>                                      5MG                                     N19901 003  Jan 28, 1991    Dec  CTEC
>A>   AB                                 5MG                                     N19901 003  Jan 28, 1991    Dec  CTEC
>D>       +                              10MG                                    N19901 004  Jan 28, 1991    Dec  CTEC
>A>   AB  +                              10MG                                    N19901 004  Jan 28, 1991    Dec  CTEC
            RAMIPRIL
>D>         @ COBALT                     1.25MG                                  N76549 001  Oct 24, 2005    Dec  CMFD
>A>   AB                                 1.25MG                                  N76549 001  Oct 24, 2005    Dec  CMFD
>D>         @                            2.5MG                                   N76549 002  Oct 24, 2005    Dec  CMFD
>A>   AB                                 2.5MG                                   N76549 002  Oct 24, 2005    Dec  CMFD
>D>         @                            5MG                                     N76549 003  Oct 24, 2005    Dec  CMFD
>A>   AB                                 5MG                                     N76549 003  Oct 24, 2005    Dec  CMFD
>D>         @                            10MG                                    N76549 004  Oct 24, 2005    Dec  CMFD
>A>   AB                                 10MG                                    N76549 004  Oct 24, 2005    Dec  CMFD

        RANITIDINE HYDROCHLORIDE
          SYRUP; ORAL
            RANITIDINE HYDROCHLORIDE
>A>   AA      RANBAXY                    EQ 15MG BASE/ML                         N78448 001  Dec 13, 2007    Dec  NEWA


        RIVASTIGMINE TARTRATE
          CAPSULE; ORAL
            RIVASTIGMINE TARTRATE
>A>   AB      WATSON LABS                EQ 1.5MG BASE                           N77129 001  Jan 08, 2008    Dec  NEWA
>A>   AB                                 EQ 3MG BASE                             N77129 002  Jan 08, 2008    Dec  NEWA
>A>   AB                                 EQ 4.5MG BASE                           N77129 003  Jan 08, 2008    Dec  NEWA
>A>   AB                                 EQ 6MG BASE                             N77129 004  Jan 08, 2008    Dec  NEWA

>A>     SAPROPTERIN DIHYDROCHLORIDE
>A>       TABLET; ORAL
>A>         KUVAN
>A>       +   BIOMARIN PHARM             100MG                                   N22181 001  Dec 13, 2007    Dec  NEWA

        SERTRALINE HYDROCHLORIDE
          TABLET; ORAL
            SERTRALINE HYDROCHLORIDE
>A>   AB      WOCKHARDT                  EQ 25MG BASE                            N78403 001  Jan 08, 2008    Dec  NEWA
>A>   AB                                 EQ 50MG BASE                            N78403 002  Jan 08, 2008    Dec  NEWA
>A>   AB                                 EQ 100MG BASE                           N78403 003  Jan 08, 2008    Dec  NEWA


        TERBUTALINE SULFATE
          INJECTABLE; INJECTION
            TERBUTALINE SULFATE
>A>   AP      AKORN                      1MG/ML                                  N78151 001  Jan 07, 2008    Dec  NEWA

        TIROFIBAN HYDROCHLORIDE
          INJECTABLE; INJECTION
            AGGRASTAT
>A>           MEDICURE                   EQ 5MG BASE/100ML (EQ 0.05MG            N20913 002  May 17, 2002    Dec  NEWA
>A>       +                              EQ 12.5MG BASE/250ML (EQ 0.05MG         N20913 003  Apr 20, 2000    Dec  NEWA
>D>       +                              EQ 0.25MG BASE/ML                       N20912 001  May 14, 1998    Dec  CPOT
>A>       +                              EQ 12.5MG BASE/50ML (EQ 0.25MG          N20912 001  May 14, 1998    Dec  CPOT
>D>       +                              EQ 0.05MG BASE/ML                       N20913 001  May 14, 1998    Dec  DISC
>A>         @                            EQ 25MG BASE/500ML (EQ 0.05MG           N20913 001  May 14, 1998    Dec  DISC

        TIZANIDINE HYDROCHLORIDE
          TABLET; ORAL
            ZANAFLEX
>D>   AB      ACORDA                     EQ 2MG BASE                             N20397 002  Feb 04, 2000    Dec  DISC
>A>         @                            EQ 2MG BASE                             N20397 002  Feb 04, 2000    Dec  DISC


        TOBRAMYCIN SULFATE
          INJECTABLE; INJECTION
            TOBRAMYCIN
>D>           ABRAXIS PHARM              EQ 1.2GM BASE/VIAL                      N50789 001  Jul 13, 2004    Dec  CAHN
>A>           APP PHARMS                 EQ 1.2GM BASE/VIAL                      N50789 001  Jul 13, 2004    Dec  CAHN





    
    

ADDITIONS/DELETIONS FOR OTC DRUG PRODUCT LIST

 




        CETIRIZINE HYDROCHLORIDE
          TABLET; ORAL
            CETIRIZINE HYDROCHLORIDE
>A>           CARACO                     5MG                                     N77631 001  Jan 11, 2008    Dec  NEWA
>A>                                      10MG                                    N77631 002  Jan 11, 2008    Dec  NEWA
            CETIRIZINE HYDROCHLORIDE ALLERGY
>A>           ACTAVIS ELIZABETH          5MG                                     N78615 003  Dec 28, 2007    Dec  NEWA
>A>                                      10MG                                    N78615 004  Dec 28, 2007    Dec  NEWA
>A>           APOTEX INC                 5MG                                     N78317 001  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N78317 002  Dec 27, 2007    Dec  NEWA
>A>           CARACO                     5MG                                     N77499 001  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N77499 002  Dec 27, 2007    Dec  NEWA
>A>           MYLAN                      5MG                                     N76677 001  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N76677 002  Dec 27, 2007    Dec  NEWA
>A>           PAR PHARM                  5MG                                     N76047 001  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N76047 002  Dec 27, 2007    Dec  NEWA
>A>           PERRIGO R AND D            5MG                                     N78336 001  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N78336 002  Dec 27, 2007    Dec  NEWA
>A>           RANBAXY                    5MG                                     N77498 001  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N77498 002  Dec 27, 2007    Dec  NEWA
>A>           SANDOZ                     5MG                                     N77946 001  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N77946 002  Dec 27, 2007    Dec  NEWA
>A>           WOCKHARDT                  5MG                                     N78427 003  Dec 28, 2007    Dec  NEWA
>A>                                      10MG                                    N78427 004  Dec 28, 2007    Dec  NEWA
            CETIRIZINE HYDROCHLORIDE HIVES
>A>           ACTAVIS ELIZABETH          5MG                                     N78615 001  Dec 28, 2007    Dec  NEWA
>A>                                      10MG                                    N78615 002  Dec 28, 2007    Dec  NEWA
>A>           APOTEX INC                 5MG                                     N78317 003  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N78317 004  Dec 27, 2007    Dec  NEWA
>A>           CARACO                     5MG                                     N77499 003  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N77499 004  Dec 27, 2007    Dec  NEWA
>A>           MYLAN                      5MG                                     N76677 004  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N76677 003  Dec 27, 2007    Dec  NEWA
>A>           PAR PHARM                  5MG                                     N76047 003  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N76047 004  Dec 27, 2007    Dec  NEWA
>A>           PERRIGO R AND D            5MG                                     N78336 003  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N78336 004  Dec 27, 2007    Dec  NEWA
>A>           RANBAXY                    5MG                                     N77498 003  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N77498 004  Dec 27, 2007    Dec  NEWA
>A>           SANDOZ                     5MG                                     N77946 003  Dec 27, 2007    Dec  NEWA
>A>                                      10MG                                    N77946 004  Dec 27, 2007    Dec  NEWA
>A>           WOCKHARDT                  5MG                                     N78427 001  Dec 28, 2007    Dec  NEWA
>A>                                      10MG                                    N78427 002  Dec 28, 2007    Dec  NEWA

        FAMOTIDINE
          TABLET, CHEWABLE; ORAL
            PEPCID AC
>A>           MERCK                      20MG                                    N20801 002  Dec 17, 2007    Dec  NEWA


>A>     OMEPRAZOLE
>A>       TABLET, DELAYED RELEASE; ORAL
>A>         OMEPRAZOLE
>A>       +   DEXCEL PHARMA              20MG                                    N22032 001  Dec 04, 2007    Dec  NEWA

 

 
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