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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Sintenovo, S.a. De C.v. to the U.S. FDA. Original Data : FDA Website

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    01 APIXABAN (1)

    02 ATENOLOL (1)

    03 CETIRIZINE DIHYDROCHLORIDE (1)

    04 FACILITIES, PERSONNEL AND OPERATING PROCEDURES AT THE NAUCALPAN (MEXICO) PLANT (1)

    05 MONTELUKAST SODIUM (1)

    06 PALIPERIDONE (1)

    07 RABEPRAZOLE SODIUM (1)

    08 SITAGLIPTIN PHOSPHATE MONOHYDRATE (1)

    09 TOFACITINIB CITRATE (1)

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    APIXABAN

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    SINTENOVO SA DE CV
    Inactive
    30653
    N/A
    2016-06-28
    II
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    ATENOLOL

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    SINTENOVA SA
    Inactive
    7586
    N/A
    1988-07-12
    II
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    CETIRIZINE DIHYDROCHLORIDE

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    SINTENOVO SA DE CV
    Inactive
    19432
    N/A
    2006-05-15
    II
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    MONTELUKAST SODIUM

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    SINTENOVO SA DE CV
    Inactive
    24747
    N/A
    2011-03-10
    II
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    PALIPERIDONE

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    SINTENOVO SA DE CV
    Active
    26254
    Complete
    2014-01-13
    2013-01-30
    2012-07-27
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    RABEPRAZOLE SODIUM

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    SINTENOVO SA DE CV
    Inactive
    23907
    N/A
    2010-06-08
    II
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    SITAGLIPTIN PHOSPHATE MONOHYDRATE

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    SINTENOVO SA DE CV
    Inactive
    28908
    N/A
    2015-05-15
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    TOFACITINIB CITRATE

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    SINTENOVO SA DE CV
    Inactive
    30554
    N/A
    2016-05-19
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    FACILITIES, PERSONNEL AND OPERATING...

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    SINTENOVO SA DE CV
    Inactive
    10401
    N/A
    1993-08-03
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