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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Novartis Pharmaceuticals Corporation

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    Novartis Pharmaceuticals Corporation
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    Switzerland
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    Klybeckstrasse 141, CH-4057, Basel
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    +41 61 324 11 11
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    Pentetreotide

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    USDMF

    Found USDMF

    9906
    Active
    PENTETREOTIDE
    1992-10-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10097
    Pentetreotide at Lichtstrasse 35, C...
    2015-04-09
    Written Confirmation

    Close WC

    Application Number
    9906
    227MF10097
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PENTETREOTIDE
    Pentetreotide at Lichtstrasse 35, C...
    Issue/Submission Date
    1992-10-09
    2015-04-09
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    Valsartan

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    USDMF

    Found USDMF

    23902
    Active
    VALSARTAN DRUG SUBSTANCE
    2010-07-02
    CEP/COS

    Found CEP/COS

    CEP 2016-290 - Rev 02
    Valid
    Valsartan
    2023-11-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23902
    CEP 2016-290 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    VALSARTAN DRUG SUBSTANCE
    Valsartan
    Issue/Submission Date
    2010-07-02
    2023-11-08
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    Amlodipine Besylate

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2008-122 - Rev 02
    Valid
    Amlodipine besilate, Process II
    2023-12-14
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    CEP 2008-122 - Rev 02
    Status
    Valid
     
    Filing Details
    Amlodipine besilate, Process II
    Issue/Submission Date
    2023-12-14
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    Baclofen

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    USDMF

    Found USDMF

    9643
    Active
    LIORESAL INTRATHECAL AMPULS/BACLOFE...
    1992-04-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    9643
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LIORESAL INTRATHECAL AMPULS/BACLOFE...
    Issue/Submission Date
    1992-04-15
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    Benzathine Benzylpenicilline

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10136
    Benzylpenicillin benzathine (1% Lec...
    2008-05-29
    Written Confirmation

    Close WC

    Application Number
    220MF10136
    Status
     
    Filing Details
    Benzylpenicillin benzathine (1% Lec...
    Issue/Submission Date
    2008-05-29
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    Cefepime Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10223
    Cefepime hydrochloride hydrate at I...
    2008-11-10
    Written Confirmation

    Close WC

    Application Number
    220MF10223
    Status
     
    Filing Details
    Cefepime hydrochloride hydrate at I...
    Issue/Submission Date
    2008-11-10
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    Ceftriaxone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10116
    Ceftriaxone Sodium hydrate (sterile...
    2011-07-25
    Written Confirmation

    Close WC

    Application Number
    223MF10116
    Status
     
    Filing Details
    Ceftriaxone Sodium hydrate (sterile...
    Issue/Submission Date
    2011-07-25
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    Cyclosporine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10083
    Japanese Pharmacopoeia cyclosporine...
    2010-03-09
    Written Confirmation

    Close WC

    Application Number
    222MF10083
    Status
     
    Filing Details
    Japanese Pharmacopoeia cyclosporine...
    Issue/Submission Date
    2010-03-09
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    Fluvastatin

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    USDMF

    Found USDMF

    23901
    Active
    FLUVASTATIN DRUG SUBSTANCE
    2010-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    23901
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLUVASTATIN DRUG SUBSTANCE
    Issue/Submission Date
    2010-06-30
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    Glycolide - lactide copolymer

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    USDMF

    Found USDMF

    6895
    Active
    POLY (DL-LACTIDE-CO-GLYCOLIDE)
    1987-03-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    6895
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    POLY (DL-LACTIDE-CO-GLYCOLIDE)
    Issue/Submission Date
    1987-03-26
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    Letrozole

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-149 - Rev 00
    Valid
    Letrozole
    2020-09-03
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-149 - Rev 00
    Status
    Valid
     
    Filing Details
    Letrozole
    Issue/Submission Date
    2020-09-03
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      Lutetium Chloride Lu-177

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      USDMF

      Found USDMF

      31705
      Active
      LUTETIUM [177 LU] TRICHLORIDE
      2017-05-02
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

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      Application Number
      31705
      Status
      Active
      Fees Unpaid
      N/A
       
      Filing Details
      LUTETIUM [177 LU] TRICHLORIDE
      Issue/Submission Date
      2017-05-02
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      NAFTIFINE HCL

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      USDMF

      Found USDMF

      16772
      Active
      NAFTIFINE HYDROCHLORIDE
      2003-08-19
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

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      Application Number
      16772
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      NAFTIFINE HYDROCHLORIDE
      Issue/Submission Date
      2003-08-19
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      Terbinafine

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      USDMF

      Found USDMF

      27059
      Active
      TERBINAFINE
      2013-06-07
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

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      Application Number
      27059
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      TERBINAFINE
      Issue/Submission Date
      2013-06-07
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      Topotecan Hydrochloride

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      USDMF

      Found USDMF

      24458
      Active
      TOPOTECAN HYDROCHLORIDE
      2011-02-02
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      24458
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      TOPOTECAN HYDROCHLORIDE
      Issue/Submission Date
      2011-02-02
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      Benzonatate

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      USDMF

      Caution USDMF

      12421
      Inactive
      TESSALON DRUG SUBSTANCE, (BENZONATA...
      1997-03-14
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      12421
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      TESSALON DRUG SUBSTANCE, (BENZONATA...
      Issue/Submission Date
      1997-03-14
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      Bisoctrizole

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      USDMF

      Caution USDMF

      17025
      Inactive
      TINOSORB(TM) MBBT
      2003-12-15
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      17025
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      TINOSORB(TM) MBBT
      Issue/Submission Date
      2003-12-15
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      • FDA
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      Chlorhexidine Gluconate

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      USDMF

      Caution USDMF

      6987
      Inactive
      CHLORHEXIDINE GLUCONATE
      1987-05-19
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      6987
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      CHLORHEXIDINE GLUCONATE
      Issue/Submission Date
      1987-05-19
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      Chlorthalidone

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      USDMF

      Caution USDMF

      6910
      Inactive
      CHLORTHALIDONE USP
      1987-03-26
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      6910
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      CHLORTHALIDONE USP
      Issue/Submission Date
      1987-03-26
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      Clofazimine

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      USDMF

      Caution USDMF

      3527
      Inactive
      LAMPRENE (CLOFAZIMINE) AS PRODUCED ...
      1979-05-04
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      3527
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      LAMPRENE (CLOFAZIMINE) AS PRODUCED ...
      Issue/Submission Date
      1979-05-04
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      Clomipramine Hydrochloride

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      USDMF

      Caution USDMF

      4583
      Inactive
      ANAFRANIL INJECTABLE (CLOMIPRAMINE ...
      1982-06-15
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      4583
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      ANAFRANIL INJECTABLE (CLOMIPRAMINE ...
      Issue/Submission Date
      1982-06-15
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      Dodecyl Sulfate

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      USDMF

      Caution USDMF

      2059
      Inactive
      SIPON (MLS) MAGNESIUM LAURYL SULFAT...
      1973-01-12
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      2059
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      SIPON (MLS) MAGNESIUM LAURYL SULFAT...
      Issue/Submission Date
      1973-01-12
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      Edotreotide

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      USDMF

      Caution USDMF

      21869
      Inactive
      SMT487 ACETATE (EDOTREOTIDE)
      2008-08-08
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      21869
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      SMT487 ACETATE (EDOTREOTIDE)
      Issue/Submission Date
      2008-08-08
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      Eudragit Rs

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      USDMF

      Caution USDMF

      7810
      Inactive
      EUDRAGITr RL/RS
      1988-12-20
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      7810
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      EUDRAGITr RL/RS
      Issue/Submission Date
      1988-12-20
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        L-Lysine Hydrochloride

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        USDMF

        Caution USDMF

        31023
        Inactive
        LYSINE HYDROCHLORIDE (HCI)-ARGININE...
        2016-09-26
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        31023
        Status
        Inactive
        Fees Unpaid
        N/A
         
        Filing Details
        LYSINE HYDROCHLORIDE (HCI)-ARGININE...
        Issue/Submission Date
        2016-09-26
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        Methylphenidate Hydrochloride

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        USDMF

        Caution USDMF

        4599
        Inactive
        RITALIN
        1982-06-16
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        4599
        Status
        Inactive
        Fees Paid
        N/A
         
        Filing Details
        RITALIN
        Issue/Submission Date
        1982-06-16
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          Nevirapine

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          USDMF

          Caution USDMF

          25221
          Inactive
          NEVIRAPINE ANHYDROUS USP
          2011-08-22
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          25221
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          NEVIRAPINE ANHYDROUS USP
          Issue/Submission Date
          2011-08-22
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          Pyrilamine

          PDF Supplier PDF
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          USDMF

          Caution USDMF

          6601
          Inactive
          PYRILAMINE BASE
          1986-09-24
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          6601
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          PYRILAMINE BASE
          Issue/Submission Date
          1986-09-24
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          Pyrilamine Maleate

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          USDMF

          Caution USDMF

          6604
          Inactive
          PYRILAMINE MALEATE
          1986-09-24
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          6604
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          PYRILAMINE MALEATE
          Issue/Submission Date
          1986-09-24
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          Rifampicin

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          USDMF

          Caution USDMF

          13398
          Inactive
          RIFAMPIN
          1998-09-01
          CEP/COS

          Close CEP/COS

          Japanese DMF

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          Application Number
          13398
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          RIFAMPIN
          Issue/Submission Date
          1998-09-01
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          Thurfyl Nicotinate

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          USDMF

          Caution USDMF

          4096
          Inactive
          TRAFURIL(THURFYL NICOTINATE)MNFG BY...
          1981-02-20
          CEP/COS

          Close CEP/COS

          Japanese DMF

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          Application Number
          4096
          Status
          Inactive
          Fees Paid
          N/A
           
          Filing Details
          TRAFURIL(THURFYL NICOTINATE)MNFG BY...
          Issue/Submission Date
          1981-02-20
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            Zidovudine

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            USDMF

            Caution USDMF

            25082
            Inactive
            ZIDOVUDINE USP
            2011-06-17
            CEP/COS

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            Japanese DMF

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            Application Number
            25082
            Status
            Inactive
            Fees Unpaid
            N/A
             
            Filing Details
            ZIDOVUDINE USP
            Issue/Submission Date
            2011-06-17
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              AL-721

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              USDMF

              Caution USDMF

              6088
              Inactive
              AL-721
              1985-11-08
              CEP/COS

              Close CEP/COS

              Japanese DMF

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              Written Confirmation

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              Application Number
              6088
              Status
              Inactive
              Fees Unpaid
              N/A
               
              Filing Details
              AL-721
              Issue/Submission Date
              1985-11-08
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                5-FU THERAPEUTIC IMPLANT

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                USDMF

                Caution USDMF

                8992
                Inactive
                5-FU THERAPEUTIC IMPLANT
                1991-02-28
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                8992
                Status
                Inactive
                Fees Unpaid
                N/A
                 
                Filing Details
                5-FU THERAPEUTIC IMPLANT
                Issue/Submission Date
                1991-02-28
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                DAROIL INVESTIGATORS

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                USDMF

                Caution USDMF

                761
                Inactive
                DAROIL INVESTIGATORS
                1964-01-09
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                761
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                DAROIL INVESTIGATORS
                Issue/Submission Date
                1964-01-09
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                STEROID/ANTI-INFECTIVE OPHTH.COMBINATIONS;SAFETY/EFFICA...

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                USDMF

                Caution USDMF

                2336
                Inactive
                STEROID/ANTI-INFECTIVE OPHTH.COMBIN...
                1974-10-24
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                2336
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                STEROID/ANTI-INFECTIVE OPHTH.COMBIN...
                Issue/Submission Date
                1974-10-24
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                2(2'-HYDROXY-5-METHYLPHENYL) BENZOTRIAZOLE

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                USDMF

                Caution USDMF

                1800
                Inactive
                2(2'-HYDROXY-5-METHYLPHENYL) BENZOT...
                1971-09-20
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                1800
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                2(2'-HYDROXY-5-METHYLPHENYL) BENZOT...
                Issue/Submission Date
                1971-09-20
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                PERSONNEL, FACILS & GEN OPERATING PROCEDURES AT EAST HA...

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                USDMF

                Caution USDMF

                3843
                Inactive
                PERSONNEL, FACILS & GEN OPERATING P...
                1980-06-16
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

                Close WC

                Application Number
                3843
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                PERSONNEL, FACILS & GEN OPERATING P...
                Issue/Submission Date
                1980-06-16
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                CGP LL637 ADJUVANT--CHEMISTRY & GMP

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                USDMF

                Caution USDMF

                5244
                Inactive
                CGP LL637 ADJUVANT--CHEMISTRY & GMP
                1984-02-09
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

                Close WC

                Application Number
                5244
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                CGP LL637 ADJUVANT--CHEMISTRY & GMP
                Issue/Submission Date
                1984-02-09
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                ADJUVANT CGP 11637:TOXICITY STUDIES & RESULTS CONDUCTED...

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                USDMF

                Caution USDMF

                5251
                Inactive
                ADJUVANT CGP 11637:TOXICITY STUDIES...
                1984-02-09
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

                Close WC

                Application Number
                5251
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                ADJUVANT CGP 11637:TOXICITY STUDIES...
                Issue/Submission Date
                1984-02-09
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                CGP 17,582B

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                USDMF

                Caution USDMF

                5889
                Inactive
                CGP 17,582B
                1984-05-21
                CEP/COS

                Close CEP/COS

                Japanese DMF

                Close JDMF

                Written Confirmation

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                Application Number
                5889
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                CGP 17,582B
                Issue/Submission Date
                1984-05-21
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                STARTING MATERIALS 1 & 3, IN NEW JERSEY AND SWITZERLAND

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                USDMF

                Caution USDMF

                7513
                Inactive
                STARTING MATERIALS 1 & 3, IN NEW JE...
                1988-06-07
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

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                Application Number
                7513
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                STARTING MATERIALS 1 & 3, IN NEW JE...
                Issue/Submission Date
                1988-06-07
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                MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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                USDMF

                Caution USDMF

                7740
                Inactive
                MANUFACTURING SITE, FACILITIES, PER...
                1988-11-01
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

                Close WC

                Application Number
                7740
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                MANUFACTURING SITE, FACILITIES, PER...
                Issue/Submission Date
                1988-11-01
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                FACILITY AND OPERATING PROCEDURES IN DORVAL, QUEBEC, CA...

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                USDMF

                Caution USDMF

                10525
                Inactive
                FACILITY AND OPERATING PROCEDURES I...
                1993-10-14
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

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                Application Number
                10525
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                FACILITY AND OPERATING PROCEDURES I...
                Issue/Submission Date
                1993-10-14
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                MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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                USDMF

                Caution USDMF

                11721
                Inactive
                MANUFACTURING SITE, FACILITIES, PER...
                1995-10-20
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Application Number
                11721
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                MANUFACTURING SITE, FACILITIES, PER...
                Issue/Submission Date
                1995-10-20
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                MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING...

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                USDMF

                Caution USDMF

                12804
                Inactive
                MANUFACTURING SITE, FACILITIES, PER...
                1997-12-16
                CEP/COS

                Close CEP/COS

                Japanese DMF

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                Written Confirmation

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                Application Number
                12804
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                MANUFACTURING SITE, FACILITIES, PER...
                Issue/Submission Date
                1997-12-16
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                TINUVIN 326

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                USDMF

                Caution USDMF

                17885
                Inactive
                TINUVIN 326
                2004-10-05
                CEP/COS

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                Application Number
                17885
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                TINUVIN 326
                Issue/Submission Date
                2004-10-05
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                PULMOSPHERE(R) PLACEBO INHALATION POWDER

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                USDMF

                Caution USDMF

                18725
                Inactive
                PULMOSPHERE(R) PLACEBO INHALATION P...
                2005-09-02
                CEP/COS

                Close CEP/COS

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                Application Number
                18725
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                PULMOSPHERE(R) PLACEBO INHALATION P...
                Issue/Submission Date
                2005-09-02
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                PULMONARY DRUG DELIVERY SYSTEM (PDDS) CLINICAL

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                USDMF

                Caution USDMF

                20988
                Inactive
                PULMONARY DRUG DELIVERY SYSTEM (PDD...
                2007-10-31
                CEP/COS

                Close CEP/COS

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                Written Confirmation

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                Application Number
                20988
                Status
                Inactive
                Fees Paid
                N/A
                 
                Filing Details
                PULMONARY DRUG DELIVERY SYSTEM (PDD...
                Issue/Submission Date
                2007-10-31
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                  KIT FOR PREPARATION OF 99M TC-RHANNEXIN V-128

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                  USDMF

                  Caution USDMF

                  29151
                  Inactive
                  KIT FOR PREPARATION OF 99M TC-RHANN...
                  2015-03-10
                  CEP/COS

                  Close CEP/COS

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                  Application Number
                  29151
                  Status
                  Inactive
                  Fees Unpaid
                  N/A
                   
                  Filing Details
                  KIT FOR PREPARATION OF 99M TC-RHANN...
                  Issue/Submission Date
                  2015-03-10
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