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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Fresenius Kabi AB Brunna to the U.S. FDA. Original Data : FDA Website

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    Fresenius Kabi AB Brunna
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    North Stockholm, Brunna
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    AMOXICILLIN SODIUM STERILE

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    FRESENIUS KABI IPSUM ...
    Active
    38349
    N/A
    2023-05-17
    II
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    AMPICILLIN SODIUM STERILE

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

    PDF Supplier PDF
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    FRESENIUS KABI IPSUM ...
    Active
    25477
    N/A
    2011-11-03
    II
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    AMPICILLIN TRIHYDRATE STERILE

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

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    FRESENIUS KABI ONCOLO...
    Inactive
    20660
    N/A
    2007-07-06
    II
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    BENDAMUSTINE HYDROCHLORIDE

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    FRESENIUS KABI ONCOLO...
    Inactive
    26656
    N/A
    2012-12-21
    II
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    BICALUTAMIDE

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    FRESENIUS KABI ONCOLO...
    Inactive
    20099
    N/A
    2006-12-28
    II
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    BUFFERED CEFTAZIDIME PENTAHYDRATE, ...

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

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

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

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    FRESENIUS KABI IPSUM ...
    Active
    25526
    N/A
    2011-11-21
    II
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    BUPIVACAINE HYDROCHLORIDE

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

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    FRESENIUS KABI ONCOLO...
    Active
    24385
    N/A
    2010-11-30
    II
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    CALCITONIN SALMON

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

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    FRESENIUS KABI ONCOLO...
    Inactive
    23995
    N/A
    2010-07-30
    II
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    CEFEPIME ARGININE STERILE

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    FRESENIUS KABI IPSUM ...
    Active
    28258
    N/A
    2014-02-04
    II
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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...
    Inactive
    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...
    Active
    25532
    N/A
    2011-12-16
    II
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    DISODIUM PAMIDRONATE

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

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    FRESENIUS KABI ONCOLO...
    Active
    25103
    N/A
    2011-07-20
    II
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    GEMCITABINE HYDROCHLORIDE

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

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    FRESENIUS KABI IPSUM ...
    Active
    36017
    N/A
    2022-12-22
    II
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    HETACILLIN POTASSIUM STERILE

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    FRESENIUS KABI IPSUM ...
    Active
    26189
    N/A
    2012-06-29
    II
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    IRINOTECAN HYDROCHLORIDE TRIHYDRATE

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    FRESENIUS KABI ONCOLO...
    Inactive
    18818
    N/A
    2005-09-23
    II
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    LETROZOLE

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    FRESENIUS KABI ONCOLO...
    Active
    21191
    Complete
    2016-02-12
    2016-02-02
    2008-01-15
    II
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    OCTREOTIDE ACETATE

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    FRESENIUS KABI IPSUM ...
    Active
    34118
    Complete
    2021-02-26
    2020-11-24
    2020-12-21
    II
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    OXALIPLATIN

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

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    FRESENIUS KABI ONCOLO...
    Active
    17966
    Complete
    2014-12-20
    2014-12-16
    2004-12-30
    II
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    PIPERACILLIN SODIUM/ TAZOBACTAM SOD...

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    FRESENIUS KABI IPSUM ...
    Active
    25545
    Complete
    2014-01-31
    2013-12-17
    2011-11-29
    II
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    ROPIVACAINE HYDROCHLORIDE

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    FRESENIUS KABI ONCOLO...
    Active
    26650
    N/A
    2012-12-25
    II
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    TEMSIROLIMUS

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    FRESENIUS KABI ONCOLO...
    Inactive
    26019
    N/A
    2012-05-22
    II
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    • FDA
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    TOPOTECAN HYDROCHLORIDE

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    FRESENIUS KABI ONCOLO...
    Inactive
    22303
    N/A
    2009-01-06
    II
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    CEFTAZIDIME PENTAHYDRATE STERILE BU...

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    FRESENIUS KABI IPSUM ...
    Active
    38741
    Complete
    2024-02-12
    2023-12-18
    2023-12-11
    II
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    MANUFACTURING SITE, FACILITIES, PER...

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    FRESENIUS USA INC
    Inactive
    5375
    N/A
    1984-05-17
    II
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    MCT LIPID EMULSION

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    FRESENIUS KABI CLAYTO...
    Inactive
    9019
    N/A
    1991-03-15
    II
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