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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fresenius SE & Co. KGaA

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    Fresenius SE & Co. KGaA
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    Germany
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    Else-Kröner-Str. 1 61352 Bad Homburg
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    Telephone
    +49 6172 608-0
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    enquiries@pharmacompass.com
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    Afatinib

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    USDMF

    Found USDMF

    30927
    Active
    AFATINIB DIMALEATE
    2016-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Afatinib Dimaleate IH
    2022-09-30
    Application Number
    30927
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    AFATINIB DIMALEATE
    Afatinib Dimaleate IH
    Issue/Submission Date
    2016-12-31
    2022-09-30
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    Alectinib Hydrochloride

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    USDMF

    Found USDMF

    33869
    Active
    ALECTINIB HYDROCHLORIDE
    2019-06-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Alectinib Hydrochloride IH
    2022-09-30
    Application Number
    33869
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    ALECTINIB HYDROCHLORIDE
    Alectinib Hydrochloride IH
    Issue/Submission Date
    2019-06-12
    2022-09-30
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    Amoxicillin Sodium

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    USDMF

    Found USDMF

    38349
    Active
    AMOXICILLIN SODIUM STERILE
    2023-05-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-267 - Rev 07
    Valid
    Amoxicillin sodium
    2022-10-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38349
    R1-CEP 2008-267 - Rev 07
    Status
    Active
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    AMOXICILLIN SODIUM STERILE
    Amoxicillin sodium
    Issue/Submission Date
    2023-05-17
    2022-10-11
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    Carfilzomib

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    USDMF

    Found USDMF

    29750
    Active
    CARFILZOMIB
    2016-01-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0115A3
    Valid
    Carfilzomib IH
    2022-09-30
    Application Number
    29750
    Indian CDSCO WC-0115A3
    Status
    Active
    Fees Paid
    N/A
     
    Valid
    2025-09-15
    Filing Details
    CARFILZOMIB
    Carfilzomib IH
    Issue/Submission Date
    2016-01-30
    2022-09-30
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      Cefepime Hydrochloride

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      USDMF

      Found USDMF

      27971
      Active
      CEFEPIME HYDROCHLORIDE STERILE
      2014-01-20
      CEP/COS

      Found CEP/COS

      CEP 2022-460 - Rev 00
      Valid
      Cefepime dihydrochloride monohydrat...
      2023-09-13
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      27971
      CEP 2022-460 - Rev 00
      Status
      Active
      Fees Paid
      Reviewed
      Valid
       
      Filing Details
      CEFEPIME HYDROCHLORIDE STERILE
      Cefepime dihydrochloride monohydrat...
      Issue/Submission Date
      2014-01-20
      2023-09-13
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      Cloxacillin Sodium

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      USDMF

      Found USDMF

      38038
      Active
      CLOXACILLIN SODIUM
      2023-04-18
      CEP/COS

      Found CEP/COS

      R1-CEP 1998-025 - Rev 08
      Valid
      Cloxacillin sodium, Sterile
      2021-06-10
      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      38038
      R1-CEP 1998-025 - Rev 08
      Status
      Active
      Fees Unpaid
      N/A
      Valid
       
      Filing Details
      CLOXACILLIN SODIUM
      Cloxacillin sodium, Sterile
      Issue/Submission Date
      2023-04-18
      2021-06-10
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      Ibrutinib

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      USDMF

      Found USDMF

      31199
      Active
      IBRUTINIB
      2017-05-12
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Found WC

      Indian CDSCO WC-0115A3
      Valid
      Ibrutinib IH
      2022-09-30
      Application Number
      31199
      Indian CDSCO WC-0115A3
      Status
      Active
      Fees Paid
      N/A
       
      Valid
      2025-09-15
      Filing Details
      IBRUTINIB
      Ibrutinib IH
      Issue/Submission Date
      2017-05-12
      2022-09-30
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        Lactulose

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        USDMF

        Found USDMF

        15253
        Active
        LACTULOSE SOLUTION USP
        2001-02-16
        CEP/COS

        Found CEP/COS

        R1-CEP 2005-023 - Rev 02
        Valid
        Lactulose, liquid
        2017-09-07
        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        15253
        R1-CEP 2005-023 - Rev 02
        Status
        Active
        Fees Paid
        Reviewed
        Valid
         
        Filing Details
        LACTULOSE SOLUTION USP
        Lactulose, liquid
        Issue/Submission Date
        2001-02-16
        2017-09-07
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          Lactulose

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          USDMF

          Found USDMF

          15254
          Active
          LACTULOSE CRYSTALS
          2001-02-16
          CEP/COS

          Found CEP/COS

          R1-CEP 2002-236 - Rev 03
          Valid
          Lactulose
          2017-10-11
          Japanese DMF

          Close JDMF

          Written Confirmation

          Close WC

          Application Number
          15254
          R1-CEP 2002-236 - Rev 03
          Status
          Active
          Fees Paid
          Reviewed
          Valid
           
          Filing Details
          LACTULOSE CRYSTALS
          Lactulose
          Issue/Submission Date
          2001-02-16
          2017-10-11
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            Lactulose

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            USDMF

            Found USDMF

            20562
            Active
            LACTULOSE CONCENTRATE USP
            2007-05-29
            CEP/COS

            Found CEP/COS

            R0-CEP 2019-138 - Rev 00
            Valid
            Lactulose, liquid, 667 g/L
            2019-11-15
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            20562
            R0-CEP 2019-138 - Rev 00
            Status
            Active
            Fees Paid
            Reviewed
            Valid
             
            Filing Details
            LACTULOSE CONCENTRATE USP
            Lactulose, liquid, 667 g/L
            Issue/Submission Date
            2007-05-29
            2019-11-15
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            Plerixafor

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            USDMF

            Found USDMF

            32615
            Active
            PLERIXAFOR
            2018-05-18
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Found WC

            Indian CDSCO WC-0115A3
            Valid
            Plerixafor IH
            2022-09-30
            Application Number
            32615
            Indian CDSCO WC-0115A3
            Status
            Active
            Fees Paid
            N/A
             
            Valid
            2025-09-15
            Filing Details
            PLERIXAFOR
            Plerixafor IH
            Issue/Submission Date
            2018-05-18
            2022-09-30
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            Ropivacaine Hydrochloride

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            USDMF

            Found USDMF

            36233
            Active
            ROPIVACAINE HYDROCHLORIDE ANHYDROUS
            2021-10-05
            CEP/COS

            Found CEP/COS

            R0-CEP 2021-130 - Rev 00
            Valid
            Ropivacaine hydrochloride monohydra...
            2021-09-14
            Japanese DMF

            Close JDMF

            Written Confirmation

            Close WC

            Application Number
            36233
            R0-CEP 2021-130 - Rev 00
            Status
            Active
            Fees Paid
            N/A
            Valid
             
            Filing Details
            ROPIVACAINE HYDROCHLORIDE ANHYDROUS
            Ropivacaine hydrochloride monohydra...
            Issue/Submission Date
            2021-10-05
            2021-09-14
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            Belinostat

            PDF Supplier PDF
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            See Less

            USDMF

            Found USDMF

            32260
            Active
            BELINOSTAT
            2018-01-05
            CEP/COS

            Close CEP/COS

            Japanese DMF

            Close JDMF

            Written Confirmation

            Caution WC

            Indian CDSCO WC-0115
            Expired
            Belinostat IH
            2019-07-08
            Application Number
            32260
            Indian CDSCO WC-0115
            Status
            Active
            Fees Paid
            N/A
             
            Expired
            2022-07-07
            Filing Details
            BELINOSTAT
            Belinostat IH
            Issue/Submission Date
            2018-01-05
            2019-07-08
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            Bicalutamide

            PDF Supplier PDF
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            See Less

            USDMF

            Close USDMF

            CEP/COS

            Found CEP/COS

            R1-CEP 2012-369 - Rev 00
            Valid
            Bicalutamide
            2021-05-20
            Japanese DMF

            Close JDMF

            Written Confirmation

            Caution WC

            Indian CDSCO WC-0115
            Expired
            Bicalutamide (USP/IH)
            2019-07-08
            Application Number
            R1-CEP 2012-369 - Rev 00
            Indian CDSCO WC-0115
            Status
            Valid
             
            Expired
            2022-07-07
            Filing Details
            Bicalutamide
            Bicalutamide (USP/IH)
            Issue/Submission Date
            2021-05-20
            2019-07-08
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            Busulfan

            PDF Supplier PDF
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            See Less

            USDMF

            Close USDMF

            CEP/COS

            Found CEP/COS

            CEP 2010-374 - Rev 07
            Valid
            Busulfan
            2023-10-13
            Japanese DMF

            Close JDMF

            Written Confirmation

            Caution WC

            Indian CDSCO WC-0115
            Expired
            Busulfan (USP/EP/BP)
            2019-07-08
            Application Number
            CEP 2010-374 - Rev 07
            Indian CDSCO WC-0115
            Status
            Valid
             
            Expired
            2022-07-07
            Filing Details
            Busulfan
            Busulfan (USP/EP/BP)
            Issue/Submission Date
            2023-10-13
            2019-07-08
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            Carboplatin

            PDF Supplier PDF
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            See Less

            USDMF

            Close USDMF

            CEP/COS

            Found CEP/COS

            R1-CEP 2001-282 - Rev 13
            Valid
            Carboplatin
            2022-03-07
            Japanese DMF

            Close JDMF

            Written Confirmation

            Caution WC

            Indian CDSCO WC-0115
            Expired
            Carboplatin (Ph. Eur./USP)
            2019-07-08
            Application Number
            R1-CEP 2001-282 - Rev 13
            Indian CDSCO WC-0115
            Status
            Valid
             
            Expired
            2022-07-07
            Filing Details
            Carboplatin
            Carboplatin (Ph. Eur./USP)
            Issue/Submission Date
            2022-03-07
            2019-07-08
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            Docetaxel

            PDF Supplier PDF
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            See Less

            USDMF

            Close USDMF

            CEP/COS

            Found CEP/COS

            CEP 2012-293 - Rev 02
            Valid
            Docetaxel
            2023-11-17
            Japanese DMF

            Close JDMF

            Written Confirmation

            Caution WC

            Indian CDSCO WC-0115
            Expired
            Docetaxel Anhydrous(USP)/Docetaxel ...
            2019-07-08
            Application Number
            CEP 2012-293 - Rev 02
            Indian CDSCO WC-0115
            Status
            Valid
             
            Expired
            2022-07-07
            Filing Details
            Docetaxel
            Docetaxel Anhydrous(USP)/Docetaxel ...
            Issue/Submission Date
            2023-11-17
            2019-07-08
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            Gemcitabine

            PDF Supplier PDF
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            USDMF

            Close USDMF

            CEP/COS

            Found CEP/COS

            R1-CEP 2008-131 - Rev 04
            Valid
            Gemcitabine hydrochloride
            2022-02-11
            Japanese DMF

            Close JDMF

            Written Confirmation

            Caution WC

            Indian CDSCO WC-0115
            Expired
            Gemcitabine Hydrochloride (Ph. Eur....
            2019-07-08
            Application Number
            R1-CEP 2008-131 - Rev 04
            Indian CDSCO WC-0115
            Status
            Valid
             
            Expired
            2022-07-07
            Filing Details
            Gemcitabine hydrochloride
            Gemcitabine Hydrochloride (Ph. Eur....
            Issue/Submission Date
            2022-02-11
            2019-07-08
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            Irinotecan Hydrochloride

            PDF Supplier PDF
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            See Less

            USDMF

            Close USDMF

            CEP/COS

            Found CEP/COS

            R0-CEP 2017-234 - Rev 02
            Valid
            Irinotecan hydrochloride trihydrate
            2022-09-02
            Japanese DMF

            Close JDMF

            Written Confirmation

            Caution WC

            Indian CDSCO WC-0115
            Expired
            Irinotecan Hydrochloride Trihydrate...
            2019-07-08
            Application Number
            R0-CEP 2017-234 - Rev 02
            Indian CDSCO WC-0115
            Status
            Valid
             
            Expired
            2022-07-07
            Filing Details
            Irinotecan hydrochloride trihydrate
            Irinotecan Hydrochloride Trihydrate...
            Issue/Submission Date
            2022-09-02
            2019-07-08
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              Lactulose

              PDF Supplier PDF
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              See Less

              USDMF

              Caution USDMF

              22328
              Inactive
              LACTULOSE SOLUTION USP
              2008-12-20
              CEP/COS

              Found CEP/COS

              R1-CEP 1998-130 - Rev 03
              Valid
              Lactulose, liquid, 670 g/l
              2007-11-30
              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              22328
              R1-CEP 1998-130 - Rev 03
              Status
              Inactive
              Fees Paid
              N/A
              Valid
               
              Filing Details
              LACTULOSE SOLUTION USP
              Lactulose, liquid, 670 g/l
              Issue/Submission Date
              2008-12-20
              2007-11-30
              ASK
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              Letrozole

              PDF Supplier PDF
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              See Less

              USDMF

              Close USDMF

              CEP/COS

              Found CEP/COS

              R1-CEP 2007-338 - Rev 03
              Valid
              Letrozole
              2023-01-09
              Japanese DMF

              Close JDMF

              Written Confirmation

              Caution WC

              Indian CDSCO WC-0115
              Expired
              Letrozole (USP/Ph. Eur./BP)
              2019-07-08
              Application Number
              R1-CEP 2007-338 - Rev 03
              Indian CDSCO WC-0115
              Status
              Valid
               
              Expired
              2022-07-07
              Filing Details
              Letrozole
              Letrozole (USP/Ph. Eur./BP)
              Issue/Submission Date
              2023-01-09
              2019-07-08
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              Oxaliplatin

              PDF Supplier PDF
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              See Less

              USDMF

              Close USDMF

              CEP/COS

              Found CEP/COS

              R1-CEP 2007-193 - Rev 05
              Valid
              Oxaliplatin
              2021-09-24
              Japanese DMF

              Close JDMF

              Written Confirmation

              Caution WC

              Indian CDSCO WC-0115
              Expired
              Oxaliplatin (USP/Ph. Eur./BP)
              2019-07-08
              Application Number
              R1-CEP 2007-193 - Rev 05
              Indian CDSCO WC-0115
              Status
              Valid
               
              Expired
              2022-07-07
              Filing Details
              Oxaliplatin
              Oxaliplatin (USP/Ph. Eur./BP)
              Issue/Submission Date
              2021-09-24
              2019-07-08
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              Paclitaxel

              PDF Supplier PDF
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              USDMF

              Close USDMF

              CEP/COS

              Found CEP/COS

              R1-CEP 2008-181 - Rev 10
              Valid
              Paclitaxel, Semi-synthetic process
              2022-10-17
              Japanese DMF

              Close JDMF

              Written Confirmation

              Caution WC

              Indian CDSCO WC-0115
              Expired
              Paclitaxel (Ph. Eur.) (Semi-synthet...
              2019-07-08
              Application Number
              R1-CEP 2008-181 - Rev 10
              Indian CDSCO WC-0115
              Status
              Valid
               
              Expired
              2022-07-07
              Filing Details
              Paclitaxel, Semi-synthetic process
              Paclitaxel (Ph. Eur.) (Semi-synthet...
              Issue/Submission Date
              2022-10-17
              2019-07-08
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              • FDA
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              Ampicillin Sodium

              PDF Supplier PDF
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              USDMF

              Found USDMF

              23287
              Active
              AMPICILLIN SODIUM STERILE
              2009-11-20
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              23287
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              AMPICILLIN SODIUM STERILE
              Issue/Submission Date
              2009-11-20
              ASK
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              Ampicillin Sodium

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              25477
              Active
              AMPICILLIN SODIUM/SULBACTAM SODIUM
              2011-11-03
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              25477
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              AMPICILLIN SODIUM/SULBACTAM SODIUM
              Issue/Submission Date
              2011-11-03
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              Ampicillin Trihydrate

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              USDMF

              Found USDMF

              23699
              Active
              AMPICILLIN TRIHYDRATE STERILE
              2010-04-07
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              23699
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              AMPICILLIN TRIHYDRATE STERILE
              Issue/Submission Date
              2010-04-07
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              Benzylpenicillin Sodium

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              USDMF

              Found USDMF

              32299
              Active
              PENICILLIN G SODIUM STERILE
              2017-12-22
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              32299
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              PENICILLIN G SODIUM STERILE
              Issue/Submission Date
              2017-12-22
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              Benzylpenicillin Sodium

              PDF Supplier PDF
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              USDMF

              Found USDMF

              32300
              Active
              BUFFERED PENICILLIN G SODIUM STERIL...
              2017-12-22
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              32300
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              BUFFERED PENICILLIN G SODIUM STERIL...
              Issue/Submission Date
              2017-12-22
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              Busulfan

              PDF Supplier PDF
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              USDMF

              Found USDMF

              24385
              Active
              BUSULFAN
              2010-11-30
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              24385
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              BUSULFAN
              Issue/Submission Date
              2010-11-30
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              Ceftazidime

              PDF Supplier PDF
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              USDMF

              Found USDMF

              20985
              Active
              BUFFERED CEFTAZIDIME PENTAHYDRATE, ...
              2007-10-31
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              20985
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              BUFFERED CEFTAZIDIME PENTAHYDRATE, ...
              Issue/Submission Date
              2007-10-31
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              Ceftriaxone

              PDF Supplier PDF
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              USDMF

              Found USDMF

              19627
              Active
              CEFTRIAXONE SODIUM STERILE
              2006-07-21
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              19627
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              CEFTRIAXONE SODIUM STERILE
              Issue/Submission Date
              2006-07-21
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              Cloxacillin Benzathine

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              26805
              Active
              CLOXACILLIN BENZATHINE STERILE
              2012-12-18
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              26805
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              CLOXACILLIN BENZATHINE STERILE
              Issue/Submission Date
              2012-12-18
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              Decitabine

              PDF Supplier PDF
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              USDMF

              Found USDMF

              25532
              Active
              DECITABINE
              2011-12-16
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              25532
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              DECITABINE
              Issue/Submission Date
              2011-12-16
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              Docetaxel

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              25103
              Active
              DOCETAXEL
              2011-07-20
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              25103
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              DOCETAXEL
              Issue/Submission Date
              2011-07-20
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              Gemcitabine

              PDF Supplier PDF
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              USDMF

              Found USDMF

              21399
              Active
              GEMCITABINE HYDROCHLORIDE
              2008-04-22
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              21399
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              GEMCITABINE HYDROCHLORIDE
              Issue/Submission Date
              2008-04-22
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              Hetacillin Potassium

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              26189
              Active
              HETACILLIN POTASSIUM STERILE
              2012-06-29
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              26189
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              HETACILLIN POTASSIUM STERILE
              Issue/Submission Date
              2012-06-29
              ASK
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              L-Arginine Hydrochloride API

              PDF Supplier PDF
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              USDMF

              Found USDMF

              28258
              Active
              CEFEPIME ARGININE STERILE
              2014-02-04
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              28258
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              CEFEPIME ARGININE STERILE
              Issue/Submission Date
              2014-02-04
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              Letrozole

              PDF Supplier PDF
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              USDMF

              Found USDMF

              21191
              Active
              LETROZOLE
              2008-01-15
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              21191
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              LETROZOLE
              Issue/Submission Date
              2008-01-15
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              Liraglutide

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              35242
              Active
              LIRAGLUTIDE
              2022-01-31
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              35242
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              LIRAGLUTIDE
              Issue/Submission Date
              2022-01-31
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              Nafcillin Sodium

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              25387
              Active
              BUFFERED NAFCILLIN SODIUM STERILE
              2011-09-01
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              25387
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              BUFFERED NAFCILLIN SODIUM STERILE
              Issue/Submission Date
              2011-09-01
              ASK
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              Octreotide Acetate

              PDF Supplier PDF
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              USDMF

              Found USDMF

              34118
              Active
              OCTREOTIDE ACETATE
              2020-12-21
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              34118
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              OCTREOTIDE ACETATE
              Issue/Submission Date
              2020-12-21
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              Oxacillin Sodium

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              24941
              Active
              BUFFERED OXACILLIN SODIUM STERILE
              2011-05-11
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              24941
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              BUFFERED OXACILLIN SODIUM STERILE
              Issue/Submission Date
              2011-05-11
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              Oxaliplatin

              PDF Supplier PDF
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              USDMF

              Found USDMF

              19610
              Active
              OXALIPLATIN
              2006-07-17
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              19610
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              OXALIPLATIN
              Issue/Submission Date
              2006-07-17
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              Paclitaxel

              PDF Supplier PDF
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              USDMF

              Found USDMF

              17966
              Active
              PACLITAXEL SEMISYNTHETIC
              2004-12-30
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              17966
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              PACLITAXEL SEMISYNTHETIC
              Issue/Submission Date
              2004-12-30
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              Penicillin G Potassium

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              25526
              Active
              BUFFERED PENICILLIN G POTASSIUM STE...
              2011-11-21
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              25526
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              BUFFERED PENICILLIN G POTASSIUM STE...
              Issue/Submission Date
              2011-11-21
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              Piperacillin + Tazobactam

              PDF Supplier PDF
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              USDMF

              Found USDMF

              25545
              Active
              PIPERACILLIN SODIUM/ TAZOBACTAM SOD...
              2011-11-29
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              25545
              Status
              Active
              Fees Unpaid
              Reviewed
               
              Filing Details
              PIPERACILLIN SODIUM/ TAZOBACTAM SOD...
              Issue/Submission Date
              2011-11-29
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              Pivmecillinam

              PDF Supplier PDF
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              USDMF

              Found USDMF

              35278
              Active
              PIVMECILLINAM HYDROCHLORIDE
              2021-10-15
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              35278
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              PIVMECILLINAM HYDROCHLORIDE
              Issue/Submission Date
              2021-10-15
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              Ribociclib

              PDF Supplier PDF
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              USDMF

              Found USDMF

              35027
              Active
              RIBOCICLIB SUCCINATE
              2020-09-10
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              35027
              Status
              Active
              Fees Paid
              N/A
               
              Filing Details
              RIBOCICLIB SUCCINATE
              Issue/Submission Date
              2020-09-10
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              Ropivacaine Hydrochloride

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              26650
              Active
              ROPIVACAINE HYDROCHLORIDE
              2012-12-25
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              26650
              Status
              Active
              Fees Unpaid
              N/A
               
              Filing Details
              ROPIVACAINE HYDROCHLORIDE
              Issue/Submission Date
              2012-12-25
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              Sugammadex Sodium

              PDF Supplier PDF
              URL Supplier Web Content
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              USDMF

              Found USDMF

              33870
              Active
              SUGAMMADEX SODIUM
              2019-06-14
              CEP/COS

              Close CEP/COS

              Japanese DMF

              Close JDMF

              Written Confirmation

              Close WC

              Application Number
              33870
              Status
              Active
              Fees Paid
              N/A
               
              Filing Details
              SUGAMMADEX SODIUM
              Issue/Submission Date
              2019-06-14
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