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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Jiangsu Hengrui Medicine

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    Jiangsu Hengrui Medicine
    China Flag
    Country
    Country
    China
    Address
    Address
    No.7 Kunlunshan Road, Lianyungang Eco & Tech Development Zone, Lianyungang, Jiangsu Province 222047
    Telephone
    Telephone
    +86 518 81220983
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.hengrui.com/en/about.html
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    Twitter

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    • FDA
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    Letrozole

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    USDMF

    Found USDMF

    23831
    Active
    LETROZOLE USP NON-STERILE BULK DRUG...
    2010-05-24
    CEP/COS

    Found CEP/COS

    CEP 2010-270 - Rev 04
    Valid
    Letrozole
    2023-11-08
    Japanese DMF

    Found JDMF

    226MF10030
    Letrozole at No. 7, Kunlunshan Road...
    2014-02-05
    Written Confirmation

    Close WC

    Application Number
    23831
    CEP 2010-270 - Rev 04
    226MF10030
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LETROZOLE USP NON-STERILE BULK DRUG...
    Letrozole
    Letrozole at No. 7, Kunlunshan Road...
    Issue/Submission Date
    2010-05-24
    2023-11-08
    2014-02-05
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    • FDA
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    Oxaliplatin

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    USDMF

    Found USDMF

    20665
    Active
    OXALIPLATIN USP
    2007-07-09
    CEP/COS

    Found CEP/COS

    CEP 2005-079 - Rev 03
    Valid
    Oxaliplatin
    2023-11-08
    Japanese DMF

    Found JDMF

    222MF10210
    Oxaliplatin at No. 7, Kunlunshan Ro...
    2010-08-04
    Written Confirmation

    Close WC

    Application Number
    20665
    CEP 2005-079 - Rev 03
    222MF10210
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    OXALIPLATIN USP
    Oxaliplatin
    Oxaliplatin at No. 7, Kunlunshan Ro...
    Issue/Submission Date
    2007-07-09
    2023-11-08
    2010-08-04
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    • FDA
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    Sevoflurane

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    USDMF

    Caution USDMF

    24903
    Inactive
    SEVOFLURANE USP, NON-STERILE, BULK ...
    2011-04-29
    CEP/COS

    Found CEP/COS

    CEP 2016-297 - Rev 01
    Valid
    Sevoflurane
    2023-11-08
    Japanese DMF

    Found JDMF

    231MF10009
    Sevoflurane “Hengrui” at No. 7,...
    2019-01-10
    Written Confirmation

    Close WC

    Application Number
    24903
    CEP 2016-297 - Rev 01
    231MF10009
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    SEVOFLURANE USP, NON-STERILE, BULK ...
    Sevoflurane
    Sevoflurane “Hengrui” at No. 7,...
    Issue/Submission Date
    2011-04-29
    2023-11-08
    2019-01-10
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    • FDA
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    Dexmedetomidine Hydrochloride

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    USDMF

    Found USDMF

    26377
    Active
    DEXMEDETOMIDINE HYDROCHLORIDE USP, ...
    2012-09-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10029
    Dexmedetomidine Hydrochloride at N...
    2016-02-02
    Written Confirmation

    Close WC

    Application Number
    26377
    228MF10029
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXMEDETOMIDINE HYDROCHLORIDE USP, ...
    Dexmedetomidine Hydrochloride at N...
    Issue/Submission Date
    2012-09-04
    2016-02-02
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    • FDA
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    Etoposide

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    USDMF

    Found USDMF

    8647
    Active
    ETOPOSIDE USP
    1990-07-02
    CEP/COS

    Found CEP/COS

    CEP 2008-037 - Rev 05
    Valid
    Etoposide
    2023-10-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8647
    CEP 2008-037 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ETOPOSIDE USP
    Etoposide
    Issue/Submission Date
    1990-07-02
    2023-10-09
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    • FDA
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    Irinotecan Hydrochloride

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    USDMF

    Found USDMF

    20739
    Active
    IRINOTECAN HYDROCHLORIDE USP (NON-S...
    2007-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10183
    Irinotecan hydrochloride hydrate "H...
    2014-09-30
    Written Confirmation

    Close WC

    Application Number
    20739
    226MF10183
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IRINOTECAN HYDROCHLORIDE USP (NON-S...
    Irinotecan hydrochloride hydrate "H...
    Issue/Submission Date
    2007-08-01
    2014-09-30
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    • FDA
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    Ifosfamide

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    USDMF

    Found USDMF

    11290
    Active
    IFOSFAMIDE USP, NON-STERILE, BULK D...
    1995-01-11
    CEP/COS

    Caution CEP/COS

    R1-CEP 2013-026 - Rev 00
    Withdrawn by Holder
    Ifosfamide
    2019-09-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11290
    R1-CEP 2013-026 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    IFOSFAMIDE USP, NON-STERILE, BULK D...
    Ifosfamide
    Issue/Submission Date
    1995-01-11
    2019-09-04
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    • FDA
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    Bupivacaine

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    USDMF

    Found USDMF

    34900
    Active
    BUPIVACAINE BASE
    2020-06-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34900
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BUPIVACAINE BASE
    Issue/Submission Date
    2020-06-29
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    • FDA
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    Carmustine

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    USDMF

    Found USDMF

    32031
    Active
    CARMUSTINE USP NON STERILE BULK DRU...
    2017-10-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32031
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CARMUSTINE USP NON STERILE BULK DRU...
    Issue/Submission Date
    2017-10-27
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    • FDA
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    Caspofungin

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    USDMF

    Found USDMF

    28472
    Active
    CASPOFUNGIN ACETATE
    2014-11-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28472
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CASPOFUNGIN ACETATE
    Issue/Submission Date
    2014-11-20
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    • FDA
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    Cisatracurium Besylate

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    USDMF

    Found USDMF

    25511
    Active
    CISATRACURIUM BESYLATE, USP, NON-ST...
    2011-11-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25511
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CISATRACURIUM BESYLATE, USP, NON-ST...
    Issue/Submission Date
    2011-11-17
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    • FDA
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    Cyclophosphamide

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    USDMF

    Found USDMF

    26041
    Active
    CYCLOPHOSPHAMIDE, USP, STERILE, BUL...
    2012-05-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26041
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CYCLOPHOSPHAMIDE, USP, STERILE, BUL...
    Issue/Submission Date
    2012-05-11
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    • FDA
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    Desflurane

    PDF Supplier PDF
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    USDMF

    Found USDMF

    28413
    Active
    DESFLURANE, USP, NON-STERILE, BULK ...
    2014-09-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28413
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DESFLURANE, USP, NON-STERILE, BULK ...
    Issue/Submission Date
    2014-09-23
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    • FDA
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    Docetaxel

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    USDMF

    Found USDMF

    24175
    Active
    DOCETAXEL TRIHYDRATE USP
    2010-09-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24175
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOCETAXEL TRIHYDRATE USP
    Issue/Submission Date
    2010-09-13
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    • FDA
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    Fondaparinux Sodium

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    USDMF

    Found USDMF

    27336
    Active
    FONDAPARINUX SODIUM USP, NON-STERIL...
    2013-09-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27336
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FONDAPARINUX SODIUM USP, NON-STERIL...
    Issue/Submission Date
    2013-09-27
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    • FDA
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    Gadobutrol

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    USDMF

    Found USDMF

    34832
    Active
    GADOBUTROL USP
    2020-05-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34832
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GADOBUTROL USP
    Issue/Submission Date
    2020-05-28
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    Gadoterate Meglumine

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    USDMF

    Found USDMF

    34673
    Active
    GADOTERATE MEGLUMINE
    2020-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34673
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GADOTERATE MEGLUMINE
    Issue/Submission Date
    2020-03-31
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    • FDA
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    Iodixanol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31200
    Active
    IODIXANOL USP
    2017-01-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31200
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    IODIXANOL USP
    Issue/Submission Date
    2017-01-11
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    • FDA
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    Rivoceranib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    37320
    Active
    RIVOCERANIB MESYLATE, NON-STERILE, ...
    2023-01-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37320
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RIVOCERANIB MESYLATE, NON-STERILE, ...
    Issue/Submission Date
    2023-01-20
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    • FDA
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    Sevoflurane

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30570
    Active
    SEVOFLURANE USP
    2016-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30570
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SEVOFLURANE USP
    Issue/Submission Date
    2016-09-28
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    • FDA
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    SHR0302

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33027
    Active
    SHR0302 NON-STERILE BULK DRUG SUBST...
    2018-08-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33027
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SHR0302 NON-STERILE BULK DRUG SUBST...
    Issue/Submission Date
    2018-08-21
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    • FDA
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    Tolvaptan

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27833
    Active
    TOLVAPTAN
    2014-01-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27833
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TOLVAPTAN
    Issue/Submission Date
    2014-01-13
    ASK
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      COREY 16

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      USDMF

      Found USDMF

      34901
      Active
      COREY 16
      2020-07-01
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      34901
      Status
      Active
      Fees Unpaid
      N/A
       
      Filing Details
      COREY 16
      Issue/Submission Date
      2020-07-01
      ASK
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      • FDA
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      SHR169106

      PDF Supplier PDF
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      USDMF

      Found USDMF

      35053
      Active
      SHR169106
      2020-08-13
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      35053
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      SHR169106
      Issue/Submission Date
      2020-08-13
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      • FDA
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      Azelastine Hydrochloride

      PDF Supplier PDF
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      USDMF

      Caution USDMF

      25626
      Inactive
      AZELASTINE HYDROCHLORIDE, NON-STERI...
      2011-12-23
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      25626
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      AZELASTINE HYDROCHLORIDE, NON-STERI...
      Issue/Submission Date
      2011-12-23
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      • FDA
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      Capecitabine

      PDF Supplier PDF
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      USDMF

      Caution USDMF

      25521
      Inactive
      CAPECITABINE USP, NON-STERILE, BULK...
      2011-11-22
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      25521
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      CAPECITABINE USP, NON-STERILE, BULK...
      Issue/Submission Date
      2011-11-22
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      • FDA
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      Gabapentin

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      USDMF

      Caution USDMF

      22015
      Inactive
      GABAPENTIN, USP, NON-STERILE, BULK ...
      2008-09-19
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      22015
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      GABAPENTIN, USP, NON-STERILE, BULK ...
      Issue/Submission Date
      2008-09-19
      ASK
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      Ioversol

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      USDMF

      Caution USDMF

      34108
      Inactive
      IOVERSOL USP, NON-STERILE, BULK DRU...
      2019-09-30
      CEP/COS

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      Application Number
      34108
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      IOVERSOL USP, NON-STERILE, BULK DRU...
      Issue/Submission Date
      2019-09-30
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      Ivabradine Hydrochloride

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      USDMF

      Caution USDMF

      32420
      Inactive
      IVABRADINE MONOSULFATE
      2018-02-07
      CEP/COS

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      Application Number
      32420
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      IVABRADINE MONOSULFATE
      Issue/Submission Date
      2018-02-07
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      Mesna

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      USDMF

      Caution USDMF

      26037
      Inactive
      MESNA USP, NON-STERILE, BULK DRUG S...
      2012-05-07
      CEP/COS

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      Application Number
      26037
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      MESNA USP, NON-STERILE, BULK DRUG S...
      Issue/Submission Date
      2012-05-07
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      Tamsulosin

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      USDMF

      Caution USDMF

      23695
      Inactive
      TAMSULOSIN HYDROCHLORIDE USP, NON-S...
      2010-04-07
      CEP/COS

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      Japanese DMF

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      Application Number
      23695
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      TAMSULOSIN HYDROCHLORIDE USP, NON-S...
      Issue/Submission Date
      2010-04-07
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      Thiotepa

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      USDMF

      Caution USDMF

      14316
      Inactive
      THIOTEPA USP NON STERILE BULK DRUG
      1999-07-29
      CEP/COS

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      Application Number
      14316
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      THIOTEPA USP NON STERILE BULK DRUG
      Issue/Submission Date
      1999-07-29
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      Trabectedin

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      USDMF

      Caution USDMF

      33677
      Inactive
      TRABECTEDIN, NON-STERILE, BULK DRUG...
      2019-05-10
      CEP/COS

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      Application Number
      33677
      Status
      Inactive
      Fees Paid
      N/A
       
      Filing Details
      TRABECTEDIN, NON-STERILE, BULK DRUG...
      Issue/Submission Date
      2019-05-10
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