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    01 Amlodipine Besylate (2)

    02 Atorvastatin (3)

    03 Bacitracin Zinc (1)

    04 Candesartan Cilexetil (1)

    05 Carvedilol (1)

    06 Clopidogrel (1)

    07 Clopidogrel Hydrochloride (2)

    08 Duloxetine (1)

    09 Enalapril Maleate (2)

    10 Esomeprazole Magnesium (1)

    11 Lansoprazole (1)

    12 Losartan Potassium (2)

    13 Lovastatin (1)

    14 Nifedipine (1)

    15 Norfloxacin (3)

    16 Olmesartan Medoxomil (1)

    17 Oxytetracycline Dihydrate (2)

    18 Pantoprazole Sodium (1)

    19 Perindopril Erbumine (2)

    20 Piroxicam (1)

    21 Rabeprazole (1)

    22 Rivaroxaban (2)

    23 Rosuvastatin Calcium (1)

    24 Simvastatin (2)

    25 Telmisartan (3)

    26 Valsartan (1)

    27 Venlafaxine Hydrochloride (1)

    28 Blank (2)

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    01 Inactive (7)

    02 Blank (36)

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    01 Valid (31)

    02 Withdrawn by Holder (7)

    03 Blank (5)

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    01 Blank (43)

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    01 Blank (43)

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    Enalapril Maleate

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    USDMF

    Caution USDMF

    12809
    Inactive
    ENALAPRIL MALEATE
    1997-12-29
    CEP/COS

    Found CEP/COS

    R1-CEP 2000-212 - Rev 02
    Valid
    Enalapril maleate
    2010-09-10
    Japanese DMF

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    Application Number
    12809
    R1-CEP 2000-212 - Rev 02
    Status
    Inactive
    Fees Unpaid
    N/A
    Valid
     
    Filing Details
    ENALAPRIL MALEATE
    Enalapril maleate
    Issue/Submission Date
    1997-12-29
    2010-09-10
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    Amlodipine Besylate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2022-449 - Rev 00
    Valid
    Amlodipine besilate, 311302
    2023-01-19
    Japanese DMF

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    Written Confirmation

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    Application Number
    R0-CEP 2022-449 - Rev 00
    Status
    Valid
     
    Filing Details
    Amlodipine besilate, 311302
    Issue/Submission Date
    2023-01-19
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    Amlodipine Besylate

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    USDMF

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    CEP/COS

    Found CEP/COS

    R1-CEP 2014-243 - Rev 01
    Valid
    Amlodipine besilate
    2021-05-11
    Japanese DMF

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    Application Number
    R1-CEP 2014-243 - Rev 01
    Status
    Valid
     
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    Amlodipine besilate
    Issue/Submission Date
    2021-05-11
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-270 - Rev 01
    Valid
    Atorvastatin calcium, 317500
    2024-02-06
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2023-270 - Rev 01
    Status
    Valid
     
    Filing Details
    Atorvastatin calcium, 317500
    Issue/Submission Date
    2024-02-06
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    Atorvastatin

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-024 - Rev 01
    Valid
    Atorvastatin calcium
    2020-05-28
    Japanese DMF

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    Written Confirmation

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    Application Number
    R1-CEP 2013-024 - Rev 01
    Status
    Valid
     
    Filing Details
    Atorvastatin calcium
    Issue/Submission Date
    2020-05-28
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    Atorvastatin

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2021-105 - Rev 01
    Valid
    Atorvastatin calcium, 315313
    2022-01-28
    Japanese DMF

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    Written Confirmation

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    Application Number
    R0-CEP 2021-105 - Rev 01
    Status
    Valid
     
    Filing Details
    Atorvastatin calcium, 315313
    Issue/Submission Date
    2022-01-28
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    Candesartan Cilexetil

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2016-132 - Rev 01
    Valid
    Candesartan cilexetil
    2024-02-19
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2016-132 - Rev 01
    Status
    Valid
     
    Filing Details
    Candesartan cilexetil
    Issue/Submission Date
    2024-02-19
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    Carvedilol

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2001-294 - Rev 04
    Valid
    Carvedilol
    2015-01-28
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2001-294 - Rev 04
    Status
    Valid
     
    Filing Details
    Carvedilol
    Issue/Submission Date
    2015-01-28
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    Clopidogrel

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2014-027 - Rev 03
    Valid
    Clopidogrel hydrogen sulfate
    2023-12-12
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    CEP 2014-027 - Rev 03
    Status
    Valid
     
    Filing Details
    Clopidogrel hydrogen sulfate
    Issue/Submission Date
    2023-12-12
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    Clopidogrel Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-251 - Rev 00
    Valid
    Clopidogrel hydrochloride
    2020-01-10
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2018-251 - Rev 00
    Status
    Valid
     
    Filing Details
    Clopidogrel hydrochloride
    Issue/Submission Date
    2020-01-10
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