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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hubei Biocause Heilen Pharmaceutical Co., Ltd

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    01 Abiraterone Acetate (1)

    02 Atropine Sulfate (1)

    03 Dexmedetomidine Hydrochloride (1)

    04 Fludarabine Phosphate (2)

    05 Flumazenil (1)

    06 Granisetron Hydrochloride (1)

    07 Homatropine Hydrobromide (1)

    08 Homatropine Methylbromide (1)

    09 Hyoscyamine Sulfate (1)

    10 Ibuprofen (2)

    11 Milrinone (1)

    12 Torsemide (1)

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    01 Active (13)

    02 Blank (1)

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    01 Valid (4)

    02 Withdrawn by Holder (1)

    03 Blank (9)

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    01 Blank (14)

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    01 Blank (14)

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    Fludarabine Phosphate

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    USDMF

    Found USDMF

    21047
    Active
    Fludarabine Phosphate Drug Substanc...
    2007-11-12
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-136 - Rev 01
    Valid
    Fludarabine phosphate
    2022-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21047
    R0-CEP 2020-136 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    Fludarabine Phosphate Drug Substanc...
    Fludarabine phosphate
    Issue/Submission Date
    2007-11-12
    2022-01-25
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    Granisetron Hydrochloride

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    USDMF

    Found USDMF

    19078
    Active
    GRANISETRON HYDROCHLORIDE, NON-STER...
    2005-12-15
    CEP/COS

    Found CEP/COS

    CEP 2008-184 - Rev 02
    Valid
    Granisetron hydrochloride
    2024-02-27
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    19078
    CEP 2008-184 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GRANISETRON HYDROCHLORIDE, NON-STER...
    Granisetron hydrochloride
    Issue/Submission Date
    2005-12-15
    2024-02-27
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    Ibuprofen

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    USDMF

    Found USDMF

    15839
    Active
    IBUPROFEN USP
    2002-01-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-099 - Rev 07
    Valid
    Ibuprofen
    2020-12-07
    Japanese DMF

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    Application Number
    15839
    R1-CEP 2002-099 - Rev 07
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IBUPROFEN USP
    Ibuprofen
    Issue/Submission Date
    2002-01-25
    2020-12-07
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    Fludarabine Phosphate

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    USDMF

    Found USDMF

    34509
    Active
    FLUDARABINE PHOSPHATE DRUG SUBSTANC...
    2020-04-29
    CEP/COS

    Caution CEP/COS

    R1-CEP 2007-311 - Rev 00
    Withdrawn by Holder
    Fludarabine phosphate
    2014-06-18
    Japanese DMF

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    Application Number
    34509
    R1-CEP 2007-311 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    FLUDARABINE PHOSPHATE DRUG SUBSTANC...
    Fludarabine phosphate
    Issue/Submission Date
    2020-04-29
    2014-06-18
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    Abiraterone Acetate

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    USDMF

    Found USDMF

    27853
    Active
    ABIRATERONE ACETATE
    2013-12-24
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    27853
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ABIRATERONE ACETATE
    Issue/Submission Date
    2013-12-24
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    Atropine Sulfate

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    USDMF

    Found USDMF

    28978
    Active
    ATROPINE SULFATE
    2014-12-25
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    28978
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ATROPINE SULFATE
    Issue/Submission Date
    2014-12-25
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    Dexmedetomidine Hydrochloride

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    USDMF

    Found USDMF

    35455
    Active
    DEXMEDETOMIDINE DRUG SUBSTANCE
    2021-08-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    35455
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEXMEDETOMIDINE DRUG SUBSTANCE
    Issue/Submission Date
    2021-08-23
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    Flumazenil

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    USDMF

    Found USDMF

    19723
    Active
    FLUMAZENIL
    2006-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

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    Written Confirmation

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    Application Number
    19723
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLUMAZENIL
    Issue/Submission Date
    2006-08-31
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    Homatropine Hydrobromide

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    USDMF

    Found USDMF

    34161
    Active
    HOMATROPINE HYDROBROMIDE
    2019-09-29
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    34161
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    HOMATROPINE HYDROBROMIDE
    Issue/Submission Date
    2019-09-29
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    Homatropine Methylbromide

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    USDMF

    Found USDMF

    28530
    Active
    HOMATROPINE METHYLBROMIDE
    2014-07-28
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    28530
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    HOMATROPINE METHYLBROMIDE
    Issue/Submission Date
    2014-07-28
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