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

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    Qilu Pharmaceutical
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    China
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    Address
    No.8888, Youyou Road, High-tech Zone, Jinan City, Shandong Province
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    +86 0531-83126666
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    enquiries@pharmacompass.com
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    • FDA
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    Cefixime

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    USDMF

    Found USDMF

    36694
    Active
    CEFIXIME
    2022-07-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-361 - Rev 00
    Valid
    Cefixime, Process 2
    2021-12-09
    Japanese DMF

    Found JDMF

    226MF10199
    Cefixime Hydrate at No. 849 Dongjia...
    2014-10-27
    Written Confirmation

    Close WC

    Application Number
    36694
    R0-CEP 2021-361 - Rev 00
    226MF10199
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CEFIXIME
    Cefixime, Process 2
    Cefixime Hydrate at No. 849 Dongjia...
    Issue/Submission Date
    2022-07-22
    2021-12-09
    2014-10-27
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    Cefpodoxime Proxetil

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    USDMF

    Found USDMF

    34502
    Active
    CEFPODOXIME PROXETIL
    2020-02-17
    CEP/COS

    Found CEP/COS

    CEP 2017-030 - Rev 01
    Valid
    Cefpodoxime proxetil
    2023-10-09
    Japanese DMF

    Found JDMF

    303MF10058
    Cefpodoxime Proxetil at No. 849 Don...
    2021-04-02
    Written Confirmation

    Close WC

    Application Number
    34502
    CEP 2017-030 - Rev 01
    303MF10058
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CEFPODOXIME PROXETIL
    Cefpodoxime proxetil
    Cefpodoxime Proxetil at No. 849 Don...
    Issue/Submission Date
    2020-02-17
    2023-10-09
    2021-04-02
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    • FDA
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    Ceftazidime

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    USDMF

    Found USDMF

    20481
    Active
    CEFTAZIDIME FOR INJECTION
    2006-12-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-195 - Rev 00
    Valid
    Ceftazidime Pentahydrate, Sterile
    2022-11-10
    Japanese DMF

    Found JDMF

    302MF10077
    Ceftazidime Hydrate at No. 849 Dong...
    2020-07-06
    Written Confirmation

    Close WC

    Application Number
    20481
    R1-CEP 2016-195 - Rev 00
    302MF10077
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CEFTAZIDIME FOR INJECTION
    Ceftazidime Pentahydrate, Sterile
    Ceftazidime Hydrate at No. 849 Dong...
    Issue/Submission Date
    2006-12-28
    2022-11-10
    2020-07-06
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    Ceftriaxone

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    USDMF

    Found USDMF

    20482
    Active
    STERILE CEFTRIAXONE SODIUM
    2006-12-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-017 - Rev 03
    Valid
    Ceftriaxone sodium, Sterile
    2018-06-29
    Japanese DMF

    Found JDMF

    302MF10095
    Ceftriaxone sodium hydrate at No. 8...
    2020-08-05
    Written Confirmation

    Close WC

    Application Number
    20482
    R1-CEP 2006-017 - Rev 03
    302MF10095
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    STERILE CEFTRIAXONE SODIUM
    Ceftriaxone sodium, Sterile
    Ceftriaxone sodium hydrate at No. 8...
    Issue/Submission Date
    2006-12-30
    2018-06-29
    2020-08-05
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    • FDA
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    Amikacin Sulfate

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    USDMF

    Found USDMF

    20874
    Active
    AMIKACIN SULFATE USP, NON-STERILE A...
    2007-09-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10057
    Day stations amikacin sulfate "prod...
    2010-02-16
    Written Confirmation

    Close WC

    Application Number
    20874
    222MF10057
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMIKACIN SULFATE USP, NON-STERILE A...
    Day stations amikacin sulfate "prod...
    Issue/Submission Date
    2007-09-18
    2010-02-16
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    • FDA
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    Cefepime

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    USDMF

    Found USDMF

    25303
    Active
    CEFEPIME FOR INJECTION
    2011-09-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-286 - Rev 01
    Valid
    Cefepime dihydrochloride monohydrat...
    2021-12-21
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25303
    R1-CEP 2011-286 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CEFEPIME FOR INJECTION
    Cefepime dihydrochloride monohydrat...
    Issue/Submission Date
    2011-09-15
    2021-12-21
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    Cefoperazone Sodium

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    USDMF

    Found USDMF

    20485
    Active
    STERILE CEFOPERAZONE SODIUM
    2006-12-20
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-202 - Rev 03
    Valid
    Cefoperazone sodium, Sterile
    2022-08-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20485
    R1-CEP 2007-202 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    STERILE CEFOPERAZONE SODIUM
    Cefoperazone sodium, Sterile
    Issue/Submission Date
    2006-12-20
    2022-08-30
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    • FDA
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    Cefprozil

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    USDMF

    Found USDMF

    26699
    Active
    CEFPROZIL
    2013-01-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-093 - Rev 01
    Valid
    Cefprozil monohydrate
    2022-06-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26699
    R1-CEP 2013-093 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CEFPROZIL
    Cefprozil monohydrate
    Issue/Submission Date
    2013-01-09
    2022-06-13
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    Cefuroxime Sodium

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    USDMF

    Found USDMF

    26346
    Active
    STERILE CEFUROXIME SODIUM PROCESS 1...
    2012-08-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-014 - Rev 02
    Valid
    Cefuroxime sodium, Sterile
    2021-12-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26346
    R1-CEP 2006-014 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    STERILE CEFUROXIME SODIUM PROCESS 1...
    Cefuroxime sodium, Sterile
    Issue/Submission Date
    2012-08-08
    2021-12-16
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    • FDA
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    Docetaxel

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    USDMF

    Found USDMF

    25576
    Active
    DOCETAXEL USP
    2011-12-09
    CEP/COS

    Found CEP/COS

    CEP 2014-105 - Rev 03
    Valid
    Docetaxel
    2024-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25576
    CEP 2014-105 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOCETAXEL USP
    Docetaxel
    Issue/Submission Date
    2011-12-09
    2024-01-31
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    • FDA
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    Granisetron Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2011-295 - Rev 03
    Valid
    Granisetron hydrochloride
    2023-09-07
    Japanese DMF

    Found JDMF

    302MF10064
    Granisetron Hydrochloride at No. 31...
    2020-06-04
    Written Confirmation

    Close WC

    Application Number
    CEP 2011-295 - Rev 03
    302MF10064
    Status
    Valid
     
    Filing Details
    Granisetron hydrochloride
    Granisetron Hydrochloride at No. 31...
    Issue/Submission Date
    2023-09-07
    2020-06-04
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    • FDA
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    Irinotecan Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    24133
    Active
    IRINOTECAN HYDROCHLORIDE (NON STERI...
    2010-08-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-276 - Rev 00
    Valid
    Irinotecan hydrochloride trihydrate
    2022-08-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24133
    R1-CEP 2016-276 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IRINOTECAN HYDROCHLORIDE (NON STERI...
    Irinotecan hydrochloride trihydrate
    Issue/Submission Date
    2010-08-19
    2022-08-25
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    • FDA
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    Olanzapine

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    USDMF

    Found USDMF

    25175
    Active
    OLANZAPINE
    2011-07-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-191 - Rev 01
    Valid
    Olanzapine, Form-II
    2021-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25175
    R1-CEP 2012-191 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OLANZAPINE
    Olanzapine, Form-II
    Issue/Submission Date
    2011-07-29
    2021-09-16
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    • FDA
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    Ondansetron Hydrochloride

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    USDMF

    Found USDMF

    17034
    Active
    ONDANSETRON HYDROCHLORIDE (NON-STER...
    2003-12-16
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-174 - Rev 04
    Valid
    Ondansetron hydrochloride dihydrate
    2023-02-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17034
    R1-CEP 2008-174 - Rev 04
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ONDANSETRON HYDROCHLORIDE (NON-STER...
    Ondansetron hydrochloride dihydrate
    Issue/Submission Date
    2003-12-16
    2023-02-01
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    • FDA
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    Oxaliplatin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23530
    Active
    OXALIPLATIN USP (NON-STERILE API)
    2010-02-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-071 - Rev 03
    Valid
    Oxaliplatin
    2021-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23530
    R1-CEP 2010-071 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OXALIPLATIN USP (NON-STERILE API)
    Oxaliplatin
    Issue/Submission Date
    2010-02-08
    2021-09-16
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    • FDA
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    Piperacillin Sodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25904
    Active
    PIPERACILLIN (NON-STERILE API)
    2012-03-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10106
    Sterile piperacillin sodium at No. ...
    2014-05-21
    Written Confirmation

    Close WC

    Application Number
    25904
    226MF10106
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PIPERACILLIN (NON-STERILE API)
    Sterile piperacillin sodium at No. ...
    Issue/Submission Date
    2012-03-01
    2014-05-21
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    Piperacillin Sodium

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    USDMF

    Found USDMF

    33786
    Active
    PIPERACILLIN USP (NON-STERILE API)
    2019-05-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10083
    Sterile Piperacillin Sodium at No. ...
    2016-04-06
    Written Confirmation

    Close WC

    Application Number
    33786
    228MF10083
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PIPERACILLIN USP (NON-STERILE API)
    Sterile Piperacillin Sodium at No. ...
    Issue/Submission Date
    2019-05-31
    2016-04-06
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    Piperacillin Sodium

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    USDMF

    Caution USDMF

    20431
    Inactive
    PIPERACILLIN (NON STERILE BULK FORM...
    2007-04-07
    CEP/COS

    Caution CEP/COS

    R0-CEP 2010-057 - Rev 00
    Withdrawn by Holder
    Piperacillin monohydrate
    2011-12-19
    Japanese DMF

    Found JDMF

    220MF10105
    Piperacillin sodium at No. 317, Xin...
    2008-04-11
    Written Confirmation

    Close WC

    Application Number
    20431
    R0-CEP 2010-057 - Rev 00
    220MF10105
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    PIPERACILLIN (NON STERILE BULK FORM...
    Piperacillin monohydrate
    Piperacillin sodium at No. 317, Xin...
    Issue/Submission Date
    2007-04-07
    2011-12-19
    2008-04-11
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    Ropivacaine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25378
    Active
    ROPIVACAINE HYDROCHLORIDE (NON STER...
    2011-09-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-270 - Rev 02
    Valid
    Ropivacaine hydrochloride monohydra...
    2021-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25378
    R1-CEP 2011-270 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ROPIVACAINE HYDROCHLORIDE (NON STER...
    Ropivacaine hydrochloride monohydra...
    Issue/Submission Date
    2011-09-29
    2021-09-16
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    Solifenacin Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29503
    Active
    SOLIFENACIN SUCCINATE (NON-STERILE,...
    2015-06-15
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-122 - Rev 00
    Valid
    Solifenacin succinate
    2023-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29503
    R0-CEP 2022-122 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SOLIFENACIN SUCCINATE (NON-STERILE,...
    Solifenacin succinate
    Issue/Submission Date
    2015-06-15
    2023-05-17
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    Tazobactam Sodium

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    USDMF

    Found USDMF

    20428
    Active
    TAZOBACTAM ACID (PROCESS I, NON-STE...
    2007-04-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10155
    Japanese Pharmacopoeia tazobactam a...
    2014-09-01
    Written Confirmation

    Close WC

    Application Number
    20428
    226MF10155
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TAZOBACTAM ACID (PROCESS I, NON-STE...
    Japanese Pharmacopoeia tazobactam a...
    Issue/Submission Date
    2007-04-05
    2014-09-01
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    Capecitabine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    24529
    Inactive
    CAPECITABINE (NON-STERILE API)
    2010-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10148
    Capecitabine at No. 10678 Wenliang ...
    2022-11-16
    Written Confirmation

    Close WC

    Application Number
    24529
    304MF10148
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    CAPECITABINE (NON-STERILE API)
    Capecitabine at No. 10678 Wenliang ...
    Issue/Submission Date
    2010-12-31
    2022-11-16
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    Carboplatin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23606
    Inactive
    CARBOPLATIN (NON-STERILE API)
    2010-02-22
    CEP/COS

    Found CEP/COS

    CEP 2010-285 - Rev 03
    Valid
    Carboplatin
    2024-02-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23606
    CEP 2010-285 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CARBOPLATIN (NON-STERILE API)
    Carboplatin
    Issue/Submission Date
    2010-02-22
    2024-02-14
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    Cefazolin Sodium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20486
    Inactive
    STERILE CEFAZOLIN SODIUM
    2006-12-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-016 - Rev 04
    Valid
    Cefazolin sodium, Sterile
    2022-09-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20486
    R1-CEP 2006-016 - Rev 04
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    STERILE CEFAZOLIN SODIUM
    Cefazolin sodium, Sterile
    Issue/Submission Date
    2006-12-28
    2022-09-15
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    Cefotaxime

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20480
    Inactive
    STERILE CEFOTAXIME SODIUM
    2007-03-19
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-406 - Rev 00
    Valid
    Cefotaxime sodium, Sterile, Process...
    2022-11-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20480
    R0-CEP 2020-406 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    STERILE CEFOTAXIME SODIUM
    Cefotaxime sodium, Sterile, Process...
    Issue/Submission Date
    2007-03-19
    2022-11-18
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    Cefuroxime Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    19521
    Inactive
    CEFUROXIME SODIUM, STERILE BULK ANT...
    2006-06-01
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-383 - Rev 00
    Valid
    Cefuroxime sodium, Sterile, Process...
    2022-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19521
    R0-CEP 2020-383 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CEFUROXIME SODIUM, STERILE BULK ANT...
    Cefuroxime sodium, Sterile, Process...
    Issue/Submission Date
    2006-06-01
    2022-07-08
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    Cisplatin

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    23985
    Inactive
    CISPLATIN (NON STERILE API)
    2010-05-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-122 - Rev 02
    Valid
    Cisplatin
    2021-09-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23985
    R1-CEP 2010-122 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CISPLATIN (NON STERILE API)
    Cisplatin
    Issue/Submission Date
    2010-05-22
    2021-09-16
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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    23458
    Inactive
    DOCETAXEL USP
    2010-01-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2011-356 - Rev 02
    Valid
    Docetaxel trihydrate
    2022-11-15
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23458
    R1-CEP 2011-356 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DOCETAXEL USP
    Docetaxel trihydrate
    Issue/Submission Date
    2010-01-08
    2022-11-15
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    Tazobactam Sodium

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Caution USDMF

    18883
    Inactive
    TAZOBACTAM ACID (INTERMEDIATE, NON-...
    2005-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10179
    Tazobactam sodium at No. 10678 Wenl...
    2017-09-21
    Written Confirmation

    Close WC

    Application Number
    18883
    229MF10179
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TAZOBACTAM ACID (INTERMEDIATE, NON-...
    Tazobactam sodium at No. 10678 Wenl...
    Issue/Submission Date
    2005-10-18
    2017-09-21
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    Terbinafine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Caution USDMF

    21717
    Inactive
    TERBINAFINE HYDROCHLORIDE (NON STER...
    2008-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10131
    Terbinafine hydrochloride at No. 31...
    2012-07-19
    Written Confirmation

    Close WC

    Application Number
    21717
    224MF10131
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    TERBINAFINE HYDROCHLORIDE (NON STER...
    Terbinafine hydrochloride at No. 31...
    Issue/Submission Date
    2008-06-06
    2012-07-19
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    Bortezomib

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29308
    Active
    BORTEZOMIB (NON-STERILE, API)
    2015-05-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29308
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BORTEZOMIB (NON-STERILE, API)
    Issue/Submission Date
    2015-05-06
    ASK
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    Cabazitaxel

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27441
    Active
    CABAZITAXEL
    2013-09-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27441
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CABAZITAXEL
    Issue/Submission Date
    2013-09-26
    ASK
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    Capecitabine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27085
    Active
    CAPECITABINE (NON-STERILE API)
    2013-04-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27085
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CAPECITABINE (NON-STERILE API)
    Issue/Submission Date
    2013-04-02
    ASK
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    Carboplatin

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    24201
    Active
    CARBOPLATIN USP
    2010-09-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24201
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CARBOPLATIN USP
    Issue/Submission Date
    2010-09-25
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    Cefazolin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    21982
    Active
    STERILE CEFAZOLIN SODIUM BULK ANTIB...
    2008-09-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21982
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    STERILE CEFAZOLIN SODIUM BULK ANTIB...
    Issue/Submission Date
    2008-09-10
    ASK
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    Cefazolin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25716
    Active
    STERILE CEFAZOLIN SODIUM PROCESS 1 ...
    2012-01-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25716
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    STERILE CEFAZOLIN SODIUM PROCESS 1 ...
    Issue/Submission Date
    2012-01-14
    ASK
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    Ceftaroline Fosamil

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    28245
    Active
    STERILE CEFTAROLINE FOSAMIL WITH AR...
    2014-06-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28245
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    STERILE CEFTAROLINE FOSAMIL WITH AR...
    Issue/Submission Date
    2014-06-25
    ASK
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    Decitabine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29749
    Active
    DECITABINE
    2015-09-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29749
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DECITABINE
    Issue/Submission Date
    2015-09-25
    ASK
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    Exemestane

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    26061
    Active
    EXEMESTANE (NON-STERILE, API)
    2012-05-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26061
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EXEMESTANE (NON-STERILE, API)
    Issue/Submission Date
    2012-05-09
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    Hydroxyurea

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    20615
    Active
    HYDROXYUREA USP (NON-STERILE BULK)
    2007-06-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20615
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HYDROXYUREA USP (NON-STERILE BULK)
    Issue/Submission Date
    2007-06-15
    ASK
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    Imatinib Mesylate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29656
    Active
    IMATINIB MESYLATE (NON-STERILE API)
    2015-08-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29656
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IMATINIB MESYLATE (NON-STERILE API)
    Issue/Submission Date
    2015-08-27
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    Olmesartan Medoxomil

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    29640
    Active
    OLMESARTAN MEDOXOMIL USP (NON-STERI...
    2015-08-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29640
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OLMESARTAN MEDOXOMIL USP (NON-STERI...
    Issue/Submission Date
    2015-08-21
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    Palonosetron

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    24661
    Active
    PALONOSETRON HYDROCHLORIDE USP (NON...
    2011-02-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24661
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PALONOSETRON HYDROCHLORIDE USP (NON...
    Issue/Submission Date
    2011-02-19
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    Pemetrexed Disodium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    23341
    Active
    PEMETREXED DISODIUM
    2009-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23341
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PEMETREXED DISODIUM
    Issue/Submission Date
    2009-11-28
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    Piperacillin + Tazobactam

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    26009
    Active
    PIPERACILLIN SODIUM AND TAZOBACTAM ...
    2012-03-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26009
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PIPERACILLIN SODIUM AND TAZOBACTAM ...
    Issue/Submission Date
    2012-03-21
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    Piperacillin + Tazobactam

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    USDMF

    Found USDMF

    20432
    Active
    PIPERACILLIN SODIUM AND TAZOBACTAM ...
    2007-04-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20432
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PIPERACILLIN SODIUM AND TAZOBACTAM ...
    Issue/Submission Date
    2007-04-09
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    Sodium Carbonate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28975
    Active
    MEROPENEM WITH SODIUM CARBONATE
    2014-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28975
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MEROPENEM WITH SODIUM CARBONATE
    Issue/Submission Date
    2014-12-29
    ASK
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    Sulbactam Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    29231
    Active
    SULBACTAM SODIUM (NON-STERILE API)
    2015-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29231
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SULBACTAM SODIUM (NON-STERILE API)
    Issue/Submission Date
    2015-03-31
    ASK
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    Tazobactam Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    27140
    Active
    TAZOBACTAM SODIUM (STERILE API)
    2013-04-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27140
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TAZOBACTAM SODIUM (STERILE API)
    Issue/Submission Date
    2013-04-25
    ASK
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    Terbinafine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
    See all info for this product

    See Less

    USDMF

    Found USDMF

    25705
    Active
    TERBINAFINE HYDROCHLORIDE (NON STER...
    2012-01-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25705
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TERBINAFINE HYDROCHLORIDE (NON STER...
    Issue/Submission Date
    2012-01-09
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