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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Fresenius SE & Co. KGaA to the U.S. FDA. Original Data : FDA Website

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    AFATINIB DIMALEATE

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    FRESENIUS KABI ONCOLO...
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    30927
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    2016-12-31
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    ALECTINIB HYDROCHLORIDE

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    FRESENIUS KABI ONCOLO...
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    33869
    N/A
    2019-06-12
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    AMOXICILLIN SODIUM STERILE

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    FRESENIUS KABI IPSUM ...
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    38349
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    2023-05-17
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    AMPICILLIN SODIUM STERILE

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    FRESENIUS KABI IPSUM ...
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    23287
    N/A
    2009-11-20
    II
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    AMPICILLIN SODIUM/SULBACTAM SODIUM

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    FRESENIUS KABI IPSUM ...
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    25477
    N/A
    2011-11-03
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    AMPICILLIN TRIHYDRATE STERILE

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    FRESENIUS KABI IPSUM ...
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    23699
    N/A
    2010-04-07
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    ANASTROZOLE

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    FRESENIUS KABI ONCOLO...
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    20660
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    2007-07-06
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    BELINOSTAT

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    FRESENIUS KABI ONCOLO...
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    32260
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    2018-01-05
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    BENDAMUSTINE HYDROCHLORIDE

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    FRESENIUS KABI ONCOLO...
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    26656
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    2012-12-21
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    BICALUTAMIDE

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    FRESENIUS KABI ONCOLO...
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    20099
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    2006-12-28
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    BUFFERED CEFTAZIDIME PENTAHYDRATE, ...

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    FRESENIUS KABI IPSUM ...
    Active
    20985
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    2014-05-16
    2014-05-05
    2007-10-31
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    BUFFERED NAFCILLIN SODIUM STERILE

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    FRESENIUS KABI IPSUM ...
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    25387
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    2014-01-03
    2013-12-17
    2011-09-01
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    BUFFERED OXACILLIN SODIUM STERILE

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    FRESENIUS KABI IPSUM ...
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    24941
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    2014-06-23
    2013-12-20
    2011-05-11
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    BUFFERED PENICILLIN G POTASSIUM STE...

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    FRESENIUS KABI IPSUM ...
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    25526
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    2011-11-21
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    BUFFERED PENICILLIN G SODIUM STERIL...

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    FRESENIUS KABI IPSUM ...
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    32300
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    2017-12-22
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    • FDA
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    BUPIVACAINE HYDROCHLORIDE

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    FRESENIUS KABI ONCOLO...
    Inactive
    26649
    N/A
    2012-12-28
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    BUSULFAN

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    FRESENIUS KABI ONCOLO...
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    24385
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    2010-11-30
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    CALCITONIN SALMON

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    FRESENIUS KABI IPSUM ...
    Active
    37738
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    2024-02-08
    2023-11-07
    2023-12-20
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    CARBOPLATIN

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    FRESENIUS KABI ONCOLO...
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    23995
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    2010-07-30
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    CARFILZOMIB

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    FRESENIUS KABI ONCOLO...
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    29750
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    2016-01-30
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    CEFEPIME ARGININE STERILE

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    FRESENIUS KABI IPSUM ...
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    28258
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    2014-02-04
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      CEFEPIME HYDROCHLORIDE STERILE

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      FRESENIUS KABI IPSUM ...
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      27971
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      2014-07-01
      2014-03-04
      2014-01-20
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      CEFOXITIN SODIUM (STERILE) DRUG SUB...

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      FRESENIUS KABI ANTI I...
      Inactive
      20698
      N/A
      2007-07-16
      II
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      CEFTRIAXONE SODIUM STERILE

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      FRESENIUS KABI IPSUM ...
      Active
      19627
      Complete
      2014-04-28
      2014-04-18
      2006-07-21
      II
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      CEFUROXIME SODIUM STERILE

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      FRESENIUS KABI ANTI I...
      Inactive
      15550
      N/A
      2001-07-24
      II
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      CEPHAPIRIN BENZATHINE STERILE

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      FRESENIUS KABI ANTI I...
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      26969
      N/A
      2013-03-06
      II
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      CEPHAPIRIN SODIUM STERILE

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      FRESENIUS KABI ANTI I...
      Inactive
      24890
      N/A
      2011-04-22
      II
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      CLOXACILLIN BENZATHINE STERILE

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      FRESENIUS KABI IPSUM ...
      Active
      26805
      N/A
      2012-12-18
      II
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      CLOXACILLIN SODIUM

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      FRESENIUS KABI IPSUM ...
      Active
      38038
      N/A
      2023-04-18
      II
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      DECITABINE

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      FRESENIUS KABI ONCOLO...
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      25532
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      2011-12-16
      II
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        DEGARELIX ACETATE

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        FRESENIUS KABI IPSUM ...
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        36499
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        2023-06-27
        2022-12-05
        2023-01-19
        II
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        DISODIUM PAMIDRONATE

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        FRESENIUS KABI ONCOLO...
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        18532
        N/A
        2005-07-20
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        DOCETAXEL

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        FRESENIUS KABI ONCOLO...
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        25103
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        2011-07-20
        II
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        GEMCITABINE HYDROCHLORIDE

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        FRESENIUS KABI ONCOLO...
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        21399
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        2013-02-08
        2012-12-19
        2008-04-22
        II
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        GLUCAGON

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        FRESENIUS KABI IPSUM ...
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        36017
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        2022-12-22
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        HETACILLIN POTASSIUM STERILE

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        FRESENIUS KABI IPSUM ...
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        26189
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        2012-06-29
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        IBRUTINIB

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        FRESENIUS KABI ONCOLO...
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        31199
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        2017-05-12
        II
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        IRINOTECAN HYDROCHLORIDE TRIHYDRATE

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        FRESENIUS KABI ONCOLO...
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        18818
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        2005-09-23
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          LACTULOSE CONCENTRATE USP

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          FRESENIUS KABI AUSTRI...
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          20562
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          2017-02-22
          2017-01-23
          2007-05-29
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            LACTULOSE CRYSTALS

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            FRESENIUS KABI AUSTRI...
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            15254
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            2013-06-25
            2012-11-28
            2001-02-16
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              LACTULOSE SOLUTION USP

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              FRESENIUS KABI AUSTRI...
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              15253
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              2015-09-09
              2014-12-12
              2001-02-16
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                LACTULOSE SOLUTION USP

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                22328
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                2008-12-20
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                LETROZOLE

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                FRESENIUS KABI ONCOLO...
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                21191
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                2016-02-12
                2016-02-02
                2008-01-15
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                LIRAGLUTIDE

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                FRESENIUS KABI IPSUM ...
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                35242
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                2022-05-17
                2022-04-08
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                METAXALONE

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                FRESENIUS KABI ONCOLO...
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                14395
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                1999-09-08
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                OCTREOTIDE ACETATE

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                FRESENIUS KABI IPSUM ...
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                2021-02-26
                2020-11-24
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                OXALIPLATIN

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                FRESENIUS KABI ONCOLO...
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                19610
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                2014-12-19
                2014-12-16
                2006-07-17
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                PACLITAXEL SEMISYNTHETIC

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                FRESENIUS KABI ONCOLO...
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                2014-12-20
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                2004-12-30
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                PENICILLIN G SODIUM STERILE

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                FRESENIUS KABI IPSUM ...
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