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    01 Astemizole (1)

    02 Atracurium Besylate (2)

    03 Atropine Sulfate (1)

    04 Benazepril Hydrochloride (1)

    05 Captopril (1)

    06 Cisatracurium Besylate (1)

    07 Decitabine (1)

    08 Deutetrabenazine (1)

    09 Enalapril Maleate (1)

    10 Enalaprilat (1)

    11 Everolimus (1)

    12 Fexofenadine Hydrochloride (1)

    13 Gefitinib (1)

    14 Gemcitabine (1)

    15 Lisinopril (1)

    16 Metformin (4)

    17 Milrinone (1)

    18 Moexipril (1)

    19 Pemetrexed Disodium (1)

    20 Quinapril (1)

    21 Ramipril (1)

    22 Rocuronium Bromide (2)

    23 Sodium Cromoglicate (1)

    24 Solifenacin Succinate (1)

    25 Sugammadex Sodium (1)

    26 Tacrolimus (1)

    27 Blank (1)

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    01 Active (17)

    02 Inactive (6)

    03 Blank (9)

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    01 Valid (13)

    02 Blank (19)

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    01 219MF10138 (1)

    02 220MF10154 (1)

    03 220MF10259 (1)

    04 227MF10035 (1)

    05 227MF10139 (1)

    06 230MF10029 (1)

    07 305MF10017 (1)

    08 Blank (25)

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    01 Blank (32)

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    Metformin

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13869
    Active
    METFORMIN HYDROCHLORIDE
    1998-11-24
    CEP/COS

    Found CEP/COS

    R1-CEP 1999-183 - Rev 04
    Valid
    Metformin Hydrochloride
    2014-02-18
    Japanese DMF

    Found JDMF

    220MF10154
    Metformin hydrochloride at Balmes 8...
    2008-06-30
    Written Confirmation

    Close WC

    Application Number
    13869
    R1-CEP 1999-183 - Rev 04
    220MF10154
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    METFORMIN HYDROCHLORIDE
    Metformin Hydrochloride
    Metformin hydrochloride at Balmes 8...
    Issue/Submission Date
    1998-11-24
    2014-02-18
    2008-06-30
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    Rocuronium Bromide

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    USDMF

    Found USDMF

    19819
    Active
    ROCURONIUM BROMIDE USP
    2006-09-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-176 - Rev 02
    Valid
    Rocuronium bromide
    2022-08-23
    Japanese DMF

    Found JDMF

    227MF10139
    Rocuronium Bromide at Balmes 85, At...
    2015-05-14
    Written Confirmation

    Close WC

    Application Number
    19819
    R1-CEP 2006-176 - Rev 02
    227MF10139
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ROCURONIUM BROMIDE USP
    Rocuronium bromide
    Rocuronium Bromide at Balmes 85, At...
    Issue/Submission Date
    2006-09-15
    2022-08-23
    2015-05-14
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    Atracurium Besylate

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    USDMF

    Found USDMF

    11607
    Active
    ATRACURIUM BESYLATE USP
    1995-07-31
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-155 - Rev 00
    Valid
    Atracurium besilate
    2013-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11607
    R1-CEP 2006-155 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ATRACURIUM BESYLATE USP
    Atracurium besilate
    Issue/Submission Date
    1995-07-31
    2013-01-31
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    Benazepril Hydrochloride

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    USDMF

    Found USDMF

    15457
    Active
    BENAZEPRIL HYDROCHLORIDE USP
    2001-05-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-261 - Rev 00
    Valid
    Benazepril hydrochloride
    2016-01-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15457
    R1-CEP 2009-261 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BENAZEPRIL HYDROCHLORIDE USP
    Benazepril hydrochloride
    Issue/Submission Date
    2001-05-04
    2016-01-26
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    Cisatracurium Besylate

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    USDMF

    Found USDMF

    24999
    Active
    CISATRACURIUM BESYLATE USP
    2011-05-30
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-285 - Rev 00
    Valid
    Cisatracurium besilate
    2022-09-26
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24999
    R1-CEP 2016-285 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CISATRACURIUM BESYLATE USP
    Cisatracurium besilate
    Issue/Submission Date
    2011-05-30
    2022-09-26
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    Enalapril Maleate

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    USDMF

    Found USDMF

    11525
    Active
    ENALAPRIL MALEATE
    1995-05-19
    CEP/COS

    Found CEP/COS

    R1-CEP 2006-104 - Rev 01
    Valid
    Enalapril maleate
    2013-03-14
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11525
    R1-CEP 2006-104 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ENALAPRIL MALEATE
    Enalapril maleate
    Issue/Submission Date
    1995-05-19
    2013-03-14
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    Everolimus

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34295
    Active
    EVEROLIMUS (2.0% BHT)
    2019-12-20
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-256 - Rev 02
    Valid
    Everolimus, 2.0% BHT
    2023-04-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34295
    R0-CEP 2019-256 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    EVEROLIMUS (2.0% BHT)
    Everolimus, 2.0% BHT
    Issue/Submission Date
    2019-12-20
    2023-04-27
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    Gefitinib

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2016-305 - Rev 00
    Valid
    Gefitinib
    2022-10-06
    Japanese DMF

    Found JDMF

    230MF10029
    Gefitinib at Balmes 85, Atico, 0800...
    2018-02-15
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2016-305 - Rev 00
    230MF10029
    Status
    Valid
     
    Filing Details
    Gefitinib
    Gefitinib at Balmes 85, Atico, 0800...
    Issue/Submission Date
    2022-10-06
    2018-02-15
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    Gemcitabine

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2011-032 - Rev 01
    Valid
    Gemcitabine hydrochloride
    2017-09-27
    Japanese DMF

    Found JDMF

    220MF10259
    Gemcitabine hydrochloride at Balmes...
    2008-12-22
    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2011-032 - Rev 01
    220MF10259
    Status
    Valid
     
    Filing Details
    Gemcitabine hydrochloride
    Gemcitabine hydrochloride at Balmes...
    Issue/Submission Date
    2017-09-27
    2008-12-22
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    Lisinopril

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    USDMF

    Found USDMF

    11535
    Active
    LISINOPRIL USP
    1995-05-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2005-249 - Rev 02
    Valid
    Lisinopril dihydrate
    2015-04-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11535
    R1-CEP 2005-249 - Rev 02
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    LISINOPRIL USP
    Lisinopril dihydrate
    Issue/Submission Date
    1995-05-26
    2015-04-02
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