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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fresenius Kabi AB Brunna

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    FRESENIUS KABI AB BRUNNA

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    Fresenius Kabi AB Brunna
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    Sweden
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    Address
    North Stockholm, Brunna
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    enquiries@pharmacompass.com
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    https://cmo.fresenius-kabi.com/brunna-sweden
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    • FDA
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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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    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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    Ampicillin Sodium

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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
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    Ampicillin Sodium

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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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    Bacampicillin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2004-188 - Rev 06
    Valid
    Bacampicillin Hydrochloride
    2022-10-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2004-188 - Rev 06
    Status
    Valid
     
    Filing Details
    Bacampicillin Hydrochloride
    Issue/Submission Date
    2022-10-10
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    Busulfan

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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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    Calcitonin

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    USDMF

    Found USDMF

    37738
    Active
    CALCITONIN SALMON
    2023-12-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37738
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    CALCITONIN SALMON
    Issue/Submission Date
    2023-12-20
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    Ceftazidime

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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

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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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    • FDA
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    Cloxacillin Benzathine

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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

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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

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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

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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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    Glucagon

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    USDMF

    Found USDMF

    36017
    Active
    GLUCAGON
    2022-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36017
    Status
    Active
    Fees Unpaid
    N/A
     
    Filing Details
    GLUCAGON
    Issue/Submission Date
    2022-12-22
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    • FDA
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    Hetacillin Potassium

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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
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    • FDA
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    L-Arginine Hydrochloride API

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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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    • FDA
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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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    • FDA
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    Nafcillin Sodium

    PDF Supplier PDF
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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
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    • FDA
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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
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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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    • FDA
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    Oxaliplatin

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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

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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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    • FDA
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    Penicillin G Potassium

    PDF Supplier PDF
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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

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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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    Ropivacaine Hydrochloride

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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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    CEFTAZIDIME PENTAHYDRATE STERILE BUFFERED / AVIBACTAM S...

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    USDMF

    Found USDMF

    38741
    Active
    CEFTAZIDIME PENTAHYDRATE STERILE BU...
    2023-12-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38741
    Status
    Active
    Fees Unpaid
    Reviewed
     
    Filing Details
    CEFTAZIDIME PENTAHYDRATE STERILE BU...
    Issue/Submission Date
    2023-12-11
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    Anastrozole

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20660
    Inactive
    ANASTROZOLE
    2007-07-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20660
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ANASTROZOLE
    Issue/Submission Date
    2007-07-06
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    Bendamustine Hydrochloride

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    USDMF

    Caution USDMF

    26656
    Inactive
    BENDAMUSTINE HYDROCHLORIDE
    2012-12-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26656
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    BENDAMUSTINE HYDROCHLORIDE
    Issue/Submission Date
    2012-12-21
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    Bicalutamide

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20099
    Inactive
    BICALUTAMIDE
    2006-12-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20099
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    BICALUTAMIDE
    Issue/Submission Date
    2006-12-28
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    Bupivacaine Hydrochloride

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    USDMF

    Caution USDMF

    26649
    Inactive
    BUPIVACAINE HYDROCHLORIDE
    2012-12-28
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    26649
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    BUPIVACAINE HYDROCHLORIDE
    Issue/Submission Date
    2012-12-28
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    Carboplatin

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    USDMF

    Caution USDMF

    23995
    Inactive
    CARBOPLATIN
    2010-07-30
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    23995
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CARBOPLATIN
    Issue/Submission Date
    2010-07-30
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    Cefoxitin Sodium

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    USDMF

    Caution USDMF

    20698
    Inactive
    CEFOXITIN SODIUM (STERILE) DRUG SUB...
    2007-07-16
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    20698
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFOXITIN SODIUM (STERILE) DRUG SUB...
    Issue/Submission Date
    2007-07-16
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    Cefuroxime Sodium

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    USDMF

    Caution USDMF

    15550
    Inactive
    CEFUROXIME SODIUM STERILE
    2001-07-24
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    15550
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEFUROXIME SODIUM STERILE
    Issue/Submission Date
    2001-07-24
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    Cephapirin Benzathine

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    USDMF

    Caution USDMF

    26969
    Inactive
    CEPHAPIRIN BENZATHINE STERILE
    2013-03-06
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    26969
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEPHAPIRIN BENZATHINE STERILE
    Issue/Submission Date
    2013-03-06
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    USDMF

    Caution USDMF

    24890
    Inactive
    CEPHAPIRIN SODIUM STERILE
    2011-04-22
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    24890
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    CEPHAPIRIN SODIUM STERILE
    Issue/Submission Date
    2011-04-22
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    Disodium Pamidronate Pentahydrate

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    USDMF

    Caution USDMF

    18532
    Inactive
    DISODIUM PAMIDRONATE
    2005-07-20
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    18532
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    DISODIUM PAMIDRONATE
    Issue/Submission Date
    2005-07-20
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    Irinotecan Hydrochloride

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    USDMF

    Caution USDMF

    18818
    Inactive
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE
    2005-09-23
    CEP/COS

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    Japanese DMF

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    Application Number
    18818
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    IRINOTECAN HYDROCHLORIDE TRIHYDRATE
    Issue/Submission Date
    2005-09-23
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    Temsirolimus

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    USDMF

    Caution USDMF

    26019
    Inactive
    TEMSIROLIMUS
    2012-05-22
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    26019
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    TEMSIROLIMUS
    Issue/Submission Date
    2012-05-22
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    Topotecan Hydrochloride

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    USDMF

    Caution USDMF

    22303
    Inactive
    TOPOTECAN HYDROCHLORIDE
    2009-01-06
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    22303
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    TOPOTECAN HYDROCHLORIDE
    Issue/Submission Date
    2009-01-06
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    MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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    USDMF

    Caution USDMF

    5375
    Inactive
    MANUFACTURING SITE, FACILITIES, PER...
    1984-05-17
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    5375
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MANUFACTURING SITE, FACILITIES, PER...
    Issue/Submission Date
    1984-05-17
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    MCT LIPID EMULSION

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    USDMF

    Caution USDMF

    9019
    Inactive
    MCT LIPID EMULSION
    1991-03-15
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    9019
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    MCT LIPID EMULSION
    Issue/Submission Date
    1991-03-15
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    Lactulose

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Application Number
    Status
     
    Filing Details
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