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

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    ZHEJIANG HISUN PHARMACEUTICAL

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    Zhejiang Hisun Pharmaceutical
    China Flag
    Country
    Country
    China
    Address
    Address
    No. 46, Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province
    Telephone
    Telephone
    +86 576-88827890
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.hisunpharm.com/main/
    Linkedin
    Linkedin
    https://www.linkedin.com/company/zhejiang-hisun-pharmaceutical-co-ltd-/
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    Twitter

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    • FDA
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    Acarbose

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    USDMF

    Found USDMF

    19069
    Active
    ACARBOSE USP
    2005-12-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-144 - Rev 01
    Valid
    Acarbose
    2021-03-17
    Japanese DMF

    Found JDMF

    218MF10411
    Acarbose at 46 Waisha Road, Jiaojia...
    2006-04-14
    Written Confirmation

    Close WC

    Application Number
    19069
    R1-CEP 2006-144 - Rev 01
    218MF10411
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ACARBOSE USP
    Acarbose
    Acarbose at 46 Waisha Road, Jiaojia...
    Issue/Submission Date
    2005-12-14
    2021-03-17
    2006-04-14
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    Doxorubicin Hydrochloride

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    USDMF

    Found USDMF

    13773
    Active
    DOXORUBICIN HYDROCHLORIDE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-262 - Rev 00
    Valid
    Doxorubicin Hydrochloride, Fermenta...
    2022-05-10
    Japanese DMF

    Found JDMF

    226MF10124
    Doxorubicin hydrochloride at 46 Wai...
    2014-07-01
    Written Confirmation

    Close WC

    Application Number
    13773
    R1-CEP 2013-262 - Rev 00
    226MF10124
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOXORUBICIN HYDROCHLORIDE USP
    Doxorubicin Hydrochloride, Fermenta...
    Doxorubicin hydrochloride at 46 Wai...
    Issue/Submission Date
    1998-09-01
    2022-05-10
    2014-07-01
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    • FDA
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    Ivermectin

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    USDMF

    Found USDMF

    21624
    Active
    IVERMECTIN USP
    2008-05-08
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-176 - Rev 05
    Valid
    Ivermectin
    2021-03-31
    Japanese DMF

    Found JDMF

    304MF10048
    Ivermectin at 46 Waisha Road, Jiaoj...
    2022-03-02
    Written Confirmation

    Close WC

    Application Number
    21624
    R1-CEP 1999-176 - Rev 05
    304MF10048
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IVERMECTIN USP
    Ivermectin
    Ivermectin at 46 Waisha Road, Jiaoj...
    Issue/Submission Date
    2008-05-08
    2021-03-31
    2022-03-02
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    • FDA
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    Pravastatin

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    USDMF

    Caution USDMF

    16309
    Inactive
    PRAVASTATIN SODIUM USP
    2002-12-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-009 - Rev 02
    Valid
    Pravastatin sodium
    2021-03-17
    Japanese DMF

    Found JDMF

    227MF10144
    Pravastatin sodium at 46 Waisha Roa...
    2015-05-20
    Written Confirmation

    Close WC

    Application Number
    16309
    R1-CEP 2002-009 - Rev 02
    227MF10144
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    PRAVASTATIN SODIUM USP
    Pravastatin sodium
    Pravastatin sodium at 46 Waisha Roa...
    Issue/Submission Date
    2002-12-13
    2021-03-17
    2015-05-20
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    • FDA
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    Adenosine

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    USDMF

    Found USDMF

    17306
    Active
    ADENOSINE USP
    2004-04-12
    CEP/COS

    Found CEP/COS

    CEP 2013-044 - Rev 02
    Valid
    Adenosine
    2024-03-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17306
    CEP 2013-044 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ADENOSINE USP
    Adenosine
    Issue/Submission Date
    2004-04-12
    2024-03-06
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    Daunorubicin HCl

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    USDMF

    Found USDMF

    13775
    Active
    DAUNORUBICIN HYDROCHLORIDE USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    CEP 2012-380 - Rev 02
    Valid
    Daunorubicin Hydrochloride
    2024-03-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13775
    CEP 2012-380 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DAUNORUBICIN HYDROCHLORIDE USP
    Daunorubicin Hydrochloride
    Issue/Submission Date
    1998-09-01
    2024-03-08
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    Doxorubicin Hydrochloride

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    USDMF

    Found USDMF

    27311
    Active
    DOXORUBICIN HYDROCHLORIDE USP (FERM...
    2013-09-09
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-151 - Rev 07
    Valid
    Doxorubicin Hydrochloride
    2022-05-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27311
    R1-CEP 1999-151 - Rev 07
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    DOXORUBICIN HYDROCHLORIDE USP (FERM...
    Doxorubicin Hydrochloride
    Issue/Submission Date
    2013-09-09
    2022-05-19
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    Lovastatin

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    USDMF

    Found USDMF

    12133
    Active
    LOVASTATIN USP
    1996-09-17
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-406 - Rev 05
    Valid
    Lovastatin
    2021-07-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12133
    R1-CEP 2001-406 - Rev 05
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LOVASTATIN USP
    Lovastatin
    Issue/Submission Date
    1996-09-17
    2021-07-02
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    Simvastatin

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    USDMF

    Found USDMF

    16305
    Active
    SIMVASTATIN USP
    2002-12-11
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-172 - Rev 04
    Valid
    Simvastatin
    2021-03-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16305
    R1-CEP 2002-172 - Rev 04
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SIMVASTATIN USP
    Simvastatin
    Issue/Submission Date
    2002-12-11
    2021-03-17
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    Bicalutamide

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    USDMF

    Found USDMF

    17878
    Active
    BICALUTAMIDE USP
    2004-12-03
    CEP/COS

    Caution CEP/COS

    R0-CEP 2013-195 - Rev 00
    Withdrawn by Holder
    Bicalutamide
    2014-09-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17878
    R0-CEP 2013-195 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    BICALUTAMIDE USP
    Bicalutamide
    Issue/Submission Date
    2004-12-03
    2014-09-19
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    Bleomycin

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    USDMF

    Caution USDMF

    12814
    Inactive
    BLEOMYCIN A2 AND B2/COPPER COMPLEX,...
    1998-01-06
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-197 - Rev 00
    Valid
    Bleomycin Sulfate, Alternative proc...
    2022-05-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12814
    R1-CEP 2012-197 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    BLEOMYCIN A2 AND B2/COPPER COMPLEX,...
    Bleomycin Sulfate, Alternative proc...
    Issue/Submission Date
    1998-01-06
    2022-05-10
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    • FDA
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    Cladribine

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    USDMF

    Found USDMF

    16205
    Active
    CLADRIBINE USP
    2002-10-22
    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-132 - Rev 00
    Withdrawn by Holder
    Cladribine
    2014-10-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16205
    R0-CEP 2012-132 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    CLADRIBINE USP
    Cladribine
    Issue/Submission Date
    2002-10-22
    2014-10-29
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    • FDA
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    Cyclophosphamide

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    USDMF

    Found USDMF

    15178
    Active
    CYCLOPHOSPHAMIDE USP
    2000-12-01
    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-279 - Rev 01
    Withdrawn by Holder
    Cyclophosphamide monohydrate
    2016-06-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15178
    R1-CEP 2005-279 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    CYCLOPHOSPHAMIDE USP
    Cyclophosphamide monohydrate
    Issue/Submission Date
    2000-12-01
    2016-06-30
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    • FDA
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    Cytarabine

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    USDMF

    Found USDMF

    15959
    Active
    CYTARABINE USP
    2002-04-28
    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-390 - Rev 03
    Withdrawn by Holder
    Cytarabine
    2016-08-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15959
    R1-CEP 2001-390 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    CYTARABINE USP
    Cytarabine
    Issue/Submission Date
    2002-04-28
    2016-08-02
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    • FDA
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    Epirubicin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    16324
    Inactive
    EPIRUBICIN HYDROCHLORIDE
    2002-12-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-077 - Rev 06
    Valid
    Epirubicin hydrochloride
    2022-05-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16324
    R1-CEP 2000-077 - Rev 06
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    EPIRUBICIN HYDROCHLORIDE
    Epirubicin hydrochloride
    Issue/Submission Date
    2002-12-18
    2022-05-10
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    • FDA
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    Fludarabine Phosphate

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    USDMF

    Found USDMF

    16807
    Active
    FLUDARABINE PHOSPHATE USP
    2003-08-27
    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-076 - Rev 00
    Withdrawn by Holder
    Fludarabine phosphate
    2013-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16807
    R1-CEP 2006-076 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    FLUDARABINE PHOSPHATE USP
    Fludarabine phosphate
    Issue/Submission Date
    2003-08-27
    2013-05-17
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    • FDA
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    Gemcitabine

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    USDMF

    Found USDMF

    24893
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2011-04-26
    CEP/COS

    Caution CEP/COS

    R0-CEP 2011-117 - Rev 01
    Withdrawn by Holder
    Gemcitabine hydrochloride
    2015-02-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24893
    R0-CEP 2011-117 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine hydrochloride
    Issue/Submission Date
    2011-04-26
    2015-02-05
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    • FDA
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    Letrozole

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    USDMF

    Found USDMF

    20356
    Active
    LETROZOLE USP
    2007-03-07
    CEP/COS

    Caution CEP/COS

    R0-CEP 2010-331 - Rev 01
    Withdrawn by Holder
    Letrozole
    2012-09-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20356
    R0-CEP 2010-331 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    LETROZOLE USP
    Letrozole
    Issue/Submission Date
    2007-03-07
    2012-09-14
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    • FDA
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    Meropenem

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    USDMF

    Caution USDMF

    26820
    Inactive
    MEROPENEM STERILE
    2013-01-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10216
    Meropenem hydrate at 46 Waisha Road...
    2012-11-12
    Written Confirmation

    Close WC

    Application Number
    26820
    224MF10216
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MEROPENEM STERILE
    Meropenem hydrate at 46 Waisha Road...
    Issue/Submission Date
    2013-01-31
    2012-11-12
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    Methotrexate

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    USDMF

    Found USDMF

    21118
    Active
    METHOTREXATE USP
    2007-11-30
    CEP/COS

    Caution CEP/COS

    R1-CEP 2007-357 - Rev 01
    Withdrawn by Holder
    Methotrexate
    2016-02-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21118
    R1-CEP 2007-357 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    METHOTREXATE USP
    Methotrexate
    Issue/Submission Date
    2007-11-30
    2016-02-11
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    Mitomycin

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    USDMF

    Found USDMF

    25659
    Active
    MITOMYCIN USP (ALTERNATIVE PROCESS)
    2011-12-30
    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-021 - Rev 00
    Withdrawn by Holder
    Mitomycin
    2011-01-25
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25659
    R1-CEP 2005-021 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    MITOMYCIN USP (ALTERNATIVE PROCESS)
    Mitomycin
    Issue/Submission Date
    2011-12-30
    2011-01-25
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    Mitomycin

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    USDMF

    Caution USDMF

    13783
    Inactive
    MITOMYCIN USP
    1998-09-01
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-013 - Rev 00
    Valid
    Mitomycin, Alternative process
    2022-05-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13783
    R1-CEP 2012-013 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MITOMYCIN USP
    Mitomycin, Alternative process
    Issue/Submission Date
    1998-09-01
    2022-05-10
    ASK
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    • FDA
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    Mycophenolate Mofetil

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    USDMF

    Caution USDMF

    25336
    Inactive
    MYCOPHENOLATE MOFETIL USP
    2011-09-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-308 - Rev 02
    Valid
    Mycophenolate mofetil
    2021-10-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25336
    R1-CEP 2012-308 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    MYCOPHENOLATE MOFETIL USP
    Mycophenolate mofetil
    Issue/Submission Date
    2011-09-29
    2021-10-22
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    Praziquantel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29271
    Active
    PRAZIQUANTEL USP
    2015-04-15
    CEP/COS

    Caution CEP/COS

    R1-CEP 2002-137 - Rev 02
    Withdrawn by Holder
    Praziquantel
    2013-02-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29271
    R1-CEP 2002-137 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Withdrawn by Holder
     
    Filing Details
    PRAZIQUANTEL USP
    Praziquantel
    Issue/Submission Date
    2015-04-15
    2013-02-27
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    Tacrolimus

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    19072
    Inactive
    TACROLIMUS (NON-STERILE ACTIVE PHAR...
    2005-12-22
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-284 - Rev 01
    Valid
    Tacrolimus monohydrate
    2022-09-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19072
    R0-CEP 2018-284 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TACROLIMUS (NON-STERILE ACTIVE PHAR...
    Tacrolimus monohydrate
    Issue/Submission Date
    2005-12-22
    2022-09-06
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    Anastrozole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    25897
    Active
    ANASTROZOLE USP
    2012-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25897
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ANASTROZOLE USP
    Issue/Submission Date
    2012-03-31
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    Apixaban

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33298
    Active
    APIXABAN
    2018-10-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33298
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    APIXABAN
    Issue/Submission Date
    2018-10-30
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    Aripiprazole

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    28341
    Active
    ARIPIPRAZOLE USP
    2014-06-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28341
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ARIPIPRAZOLE USP
    Issue/Submission Date
    2014-06-11
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    Bleomycin

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

    See Less

    USDMF

    Found USDMF

    26312
    Active
    BLEOMYCIN SULFATE USP (PROCESS II)
    2012-09-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26312
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BLEOMYCIN SULFATE USP (PROCESS II)
    Issue/Submission Date
    2012-09-21
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    Bleomycin

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

    See Less

    USDMF

    Caution USDMF

    12962
    Inactive
    BLEOMYCIN SULFATE USP
    1998-04-24
    CEP/COS

    Caution CEP/COS

    R1-CEP 2001-422 - Rev 02
    Withdrawn by Holder
    Bleomycin Sulfate
    2012-06-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12962
    R1-CEP 2001-422 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    BLEOMYCIN SULFATE USP
    Bleomycin Sulfate
    Issue/Submission Date
    1998-04-24
    2012-06-05
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      Dabigatran Etexilate Mesylate

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

      See Less

      USDMF

      Found USDMF

      32941
      Active
      DABIGATRAN ETEXILATE MESYLATE
      2018-06-29
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      32941
      Status
      Active
      Fees Unpaid
      N/A
       
      Filing Details
      DABIGATRAN ETEXILATE MESYLATE
      Issue/Submission Date
      2018-06-29
      ASK
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      Dactinomycin

      PDF Supplier PDF
      URL Supplier Web Content
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      USDMF

      Found USDMF

      20658
      Active
      DACTINOMYCIN USP
      2007-06-20
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      20658
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      DACTINOMYCIN USP
      Issue/Submission Date
      2007-06-20
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      Daptomycin

      PDF Supplier PDF
      URL Supplier Web Content
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      See Less

      USDMF

      Found USDMF

      26604
      Active
      DAPTOMYCIN
      2012-12-21
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      26604
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      DAPTOMYCIN
      Issue/Submission Date
      2012-12-21
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      Donepezil

      PDF Supplier PDF
      URL Supplier Web Content
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      See Less

      USDMF

      Found USDMF

      26605
      Active
      DONEPEZIL HYDROCHLORIDE USP
      2012-12-27
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      26605
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      DONEPEZIL HYDROCHLORIDE USP
      Issue/Submission Date
      2012-12-27
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      Idarubicin Hydrochloride

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

      See Less

      USDMF

      Found USDMF

      19613
      Active
      IDARUBICIN HYDROCHLORIDE USP
      2006-07-17
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      19613
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      IDARUBICIN HYDROCHLORIDE USP
      Issue/Submission Date
      2006-07-17
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      Linezolid

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

      See Less

      USDMF

      Found USDMF

      28596
      Active
      LINEZOLID
      2014-09-05
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      28596
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      LINEZOLID
      Issue/Submission Date
      2014-09-05
      ASK
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        Lurasidone Hydrochloride

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

        See Less

        USDMF

        Found USDMF

        32002
        Active
        LURASIDONE HYDROCHLORIDE
        2017-08-18
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        32002
        Status
        Active
        Fees Unpaid
        N/A
         
        Filing Details
        LURASIDONE HYDROCHLORIDE
        Issue/Submission Date
        2017-08-18
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        Mesna

        PDF Supplier PDF
        URL Supplier Web Content
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        USDMF

        Found USDMF

        16255
        Active
        MESNA USP
        2002-11-15
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        16255
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        MESNA USP
        Issue/Submission Date
        2002-11-15
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        Mevastatin

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

        See Less

        USDMF

        Found USDMF

        22227
        Active
        MEVASTATIN
        2008-11-14
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        22227
        Status
        Active
        Fees Paid
        N/A
         
        Filing Details
        MEVASTATIN
        Issue/Submission Date
        2008-11-14
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        Micafungin

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

        See Less

        USDMF

        Found USDMF

        27435
        Active
        MICAFUNGIN SODIUM
        2013-09-25
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        27435
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        MICAFUNGIN SODIUM
        Issue/Submission Date
        2013-09-25
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        Minocycline Hydrochloride

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

        See Less

        USDMF

        Found USDMF

        26050
        Active
        MINOCYCLINE HYDROCHLORIDE USP
        2012-07-20
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        26050
        Status
        Active
        Fees Paid
        N/A
         
        Filing Details
        MINOCYCLINE HYDROCHLORIDE USP
        Issue/Submission Date
        2012-07-20
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        Mycophenolate Mofetil

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

        See Less

        USDMF

        Found USDMF

        26405
        Active
        MYCOPHENOLATE MOFETIL USP
        2012-11-23
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        26405
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        MYCOPHENOLATE MOFETIL USP
        Issue/Submission Date
        2012-11-23
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        Mycophenolic Acid

        PDF Supplier PDF
        URL Supplier Web Content
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        USDMF

        Found USDMF

        26404
        Active
        MYCOPHENOLIC ACID
        2012-09-19
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        26404
        Status
        Active
        Fees Paid
        N/A
         
        Filing Details
        MYCOPHENOLIC ACID
        Issue/Submission Date
        2012-09-19
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        Olanzapine

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

        See Less

        USDMF

        Found USDMF

        27219
        Active
        OLANZAPINE USP
        2013-07-09
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        27219
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        OLANZAPINE USP
        Issue/Submission Date
        2013-07-09
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        Pneumocandin M1

        PDF Supplier PDF
        URL Supplier Web Content
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        USDMF

        Found USDMF

        27434
        Active
        FR179642
        2013-08-29
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        27434
        Status
        Active
        Fees Paid
        N/A
         
        Filing Details
        FR179642
        Issue/Submission Date
        2013-08-29
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        Pravastatin

        PDF Supplier PDF
        URL Supplier Web Content
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        USDMF

        Found USDMF

        27615
        Active
        PRAVASTATIN SODIUM USP (PROCESS II)
        2013-10-21
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        27615
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        PRAVASTATIN SODIUM USP (PROCESS II)
        Issue/Submission Date
        2013-10-21
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        Sirolimus

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

        See Less

        USDMF

        Found USDMF

        27725
        Active
        SIROLIMUS
        2013-12-31
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        27725
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        SIROLIMUS
        Issue/Submission Date
        2013-12-31
        ASK
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        Tacrolimus

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

        See Less

        USDMF

        Found USDMF

        27202
        Active
        TACROLIMUS USP
        2013-06-27
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        27202
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        TACROLIMUS USP
        Issue/Submission Date
        2013-06-27
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        Ticagrelor

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

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        USDMF

        Found USDMF

        28923
        Active
        TICAGRELOR
        2014-12-25
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        28923
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        TICAGRELOR
        Issue/Submission Date
        2014-12-25
        ASK
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        • FDA
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        Tigecycline

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

        See Less

        USDMF

        Found USDMF

        26311
        Active
        TIGECYCLINE USP
        2012-09-04
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        26311
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        TIGECYCLINE USP
        Issue/Submission Date
        2012-09-04
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