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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Gilead Sciences

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    Amphotericin B

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    USDMF

    Found USDMF

    9564
    Active
    AMBISOME, LIPOSOMAL AMPHOTERICIN B
    1992-03-06
    CEP/COS

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    Application Number
    9564
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    AMBISOME, LIPOSOMAL AMPHOTERICIN B
    Issue/Submission Date
    1992-03-06
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    Cobicistat

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    USDMF

    Found USDMF

    25188
    Active
    COBICISTAT ON SILICON DIOXIDE
    2011-10-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    25188
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    COBICISTAT ON SILICON DIOXIDE
    Issue/Submission Date
    2011-10-24
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    Elvitegravir

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    USDMF

    Found USDMF

    25187
    Active
    ELVITEGRAVIR
    2011-10-21
    CEP/COS

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    Application Number
    25187
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    ELVITEGRAVIR
    Issue/Submission Date
    2011-10-21
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    Emtricitabine

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    USDMF

    Close USDMF

    CEP/COS

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    Japanese DMF

    Found JDMF

    229MF10061
    Emtricitabine at 1021 Hayter Road E...
    2017-03-07
    Written Confirmation

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    Application Number
    229MF10061
    Status
     
    Filing Details
    Emtricitabine at 1021 Hayter Road E...
    Issue/Submission Date
    2017-03-07
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    Tenofovir

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10232
    Tenofovir Ara Fe Nami de fumarate a...
    2015-09-24
    Written Confirmation

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    Application Number
    227MF10232
    Status
     
    Filing Details
    Tenofovir Ara Fe Nami de fumarate a...
    Issue/Submission Date
    2015-09-24
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    2-Phosphonomethyl-Pentanedioic Acid

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    USDMF

    Caution USDMF

    12688
    Inactive
    PMPA GEL
    1997-10-07
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    12688
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PMPA GEL
    Issue/Submission Date
    1997-10-07
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    Aconiazide

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    USDMF

    Caution USDMF

    8724
    Inactive
    ACONIAZIDE
    1990-09-07
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    8724
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ACONIAZIDE
    Issue/Submission Date
    1990-09-07
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    Didanosine

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    USDMF

    Caution USDMF

    7680
    Inactive
    2',3'-DIDEOXYINOSINE
    1988-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    7680
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    2',3'-DIDEOXYINOSINE
    Issue/Submission Date
    1988-09-23
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    Dobutamine Hydrochloride

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    USDMF

    Caution USDMF

    9024
    Inactive
    DOBUTAMINE HYDROCHLORIDE
    1991-03-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    9024
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    DOBUTAMINE HYDROCHLORIDE
    Issue/Submission Date
    1991-03-13
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    Lurtotecan

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    USDMF

    Caution USDMF

    16237
    Inactive
    LIPOSOMAL LURTOTECAN FOR INJECTION ...
    2002-11-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16237
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    LIPOSOMAL LURTOTECAN FOR INJECTION ...
    Issue/Submission Date
    2002-11-06
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    • FDA
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    Triacetyluridine

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    USDMF

    Caution USDMF

    9517
    Inactive
    2',3',5'-TRI-O-ACETYLURIDINE
    1992-01-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9517
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    2',3',5'-TRI-O-ACETYLURIDINE
    Issue/Submission Date
    1992-01-31
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    Zalcitabine

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    USDMF

    Caution USDMF

    6805
    Inactive
    2',3'-DIDEOXYCYTIDINE
    1987-01-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6805
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    2',3'-DIDEOXYCYTIDINE
    Issue/Submission Date
    1987-01-28
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      MURINE MONOCLONAL ANTIBODY AND F(AB)2 FRAGMENT (IMMU-14...

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      USDMF

      Caution USDMF

      18589
      Inactive
      MURINE MONOCLONAL ANTIBODY AND F(AB...
      1990-09-14
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      18589
      Status
      Inactive
      Fees Unpaid
      N/A
       
      Filing Details
      MURINE MONOCLONAL ANTIBODY AND F(AB...
      Issue/Submission Date
      1990-09-14
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        MURINE MONOCLONAL ANTIBODY (IMMU-31) TO ALPHA-FETOPROTE...

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        USDMF

        Caution USDMF

        18600
        Inactive
        MURINE MONOCLONAL ANTIBODY (IMMU-31...
        1989-04-28
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        18600
        Status
        Inactive
        Fees Unpaid
        N/A
         
        Filing Details
        MURINE MONOCLONAL ANTIBODY (IMMU-31...
        Issue/Submission Date
        1989-04-28
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          MURINE MONOCLONAL ANTIBODY (IMM-LL-2) TO B-CELL LYMPHOM...

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          USDMF

          Caution USDMF

          18603
          Inactive
          MURINE MONOCLONAL ANTIBODY (IMM-LL-...
          1989-11-02
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          18603
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          MURINE MONOCLONAL ANTIBODY (IMM-LL-...
          Issue/Submission Date
          1989-11-02
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          • FDA
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          G. METHODS AND PROPERTIES OF 2'-3'-DIDEOXYADENOSINE

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          USDMF

          Caution USDMF

          7192
          Inactive
          G. METHODS AND PROPERTIES OF 2'-3'-...
          1987-10-19
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          7192
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          G. METHODS AND PROPERTIES OF 2'-3'-...
          Issue/Submission Date
          1987-10-19
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          • FDA
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          FACILITY AND PROCEDURES FOR GAMMA RAY STERILIZATION

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          USDMF

          Caution USDMF

          7781
          Inactive
          FACILITY AND PROCEDURES FOR GAMMA R...
          1988-11-21
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          7781
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          FACILITY AND PROCEDURES FOR GAMMA R...
          Issue/Submission Date
          1988-11-21
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          • FDA
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          INTERMEDIATE FOR ACA-147, 4-(2,2-DIMETHYLPROPYL)-N-HEXY...

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          USDMF

          Caution USDMF

          10756
          Inactive
          INTERMEDIATE FOR ACA-147, 4-(2,2-DI...
          1994-02-28
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          10756
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          INTERMEDIATE FOR ACA-147, 4-(2,2-DI...
          Issue/Submission Date
          1994-02-28
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          MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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          USDMF

          Caution USDMF

          10967
          Inactive
          MANUFACTURING SITE, FACILITIES, PER...
          1994-06-15
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          10967
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          MANUFACTURING SITE, FACILITIES, PER...
          Issue/Submission Date
          1994-06-15
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          FK506LC AND PLACEBO

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          USDMF

          Caution USDMF

          15661
          Inactive
          FK506LC AND PLACEBO
          2001-10-12
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          15661
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          FK506LC AND PLACEBO
          Issue/Submission Date
          2001-10-12
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          • FDA
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          LIPOSOMAL OSI-7904 FOR INJECTION (OSI-7904L)

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          USDMF

          Caution USDMF

          16033
          Inactive
          LIPOSOMAL OSI-7904 FOR INJECTION (O...
          2002-06-28
          CEP/COS

          Close CEP/COS

          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          16033
          Status
          Inactive
          Fees Unpaid
          N/A
           
          Filing Details
          LIPOSOMAL OSI-7904 FOR INJECTION (O...
          Issue/Submission Date
          2002-06-28
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