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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Divis Laboratories Ltd to the U.S. FDA. Original Data : FDA Website

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    01 2-4-WING ACTIVE ESTER (1)

    02 5-PHENYLHYDANTOIN (1)

    03 A WINGS (1)

    04 B WINGS (1)

    05 BOC CORE SUCCINATE (INTERMEDIATE) (1)

    06 BUPROPION HYDROCHLORIDE USP (1)

    07 CAPECITABINE (1)

    08 CARBIDOPA USP (1)

    09 DESLORATADINE (1)

    10 DEXTROMETHORPHAN BASE USP (1)

    11 DEXTROMETHORPHAN HYDROBROMIDE USP (1)

    12 DILTIAZEM HYDROCHLORIDE USP (1)

    13 FOSPHENYTOIN SODIUM USP (1)

    14 GABAPENTIN USP (1)

    15 IOHEXOL (1)

    16 IOPAMIDOL USP (1)

    17 IRBESARTAN USP (2)

    18 KETOENAMINE (1)

    19 KETOROLAC ACID (1)

    20 LACOSAMIDE (1)

    21 LEVETIRACETAM (1)

    22 LEVETIRACETAM (PROCESS B) (1)

    23 LEVODOPA USP (1)

    24 LORATADINE USP (1)

    25 MESALAMINE USP (1)

    26 METHYLDOPA USP (1)

    27 NABUMETONE USP (1)

    28 NAPROXEN SODIUM USP (1)

    29 NAPROXEN USP (1)

    30 NIACIN USP (1)

    31 OLMESARTAN MEDOXOMIL USP (1)

    32 ORLISTAT (1)

    33 PHENYLEPHRINE HYDROCHLORIDE USP (1)

    34 PREGABALIN (1)

    35 PREGABALIN (ALTERNATIVE PROCESS) (1)

    36 PROGUANIL HYDROCHLORIDE (1)

    37 QUETIAPINE FUMARATE (1)

    38 RISEDRONATE SODIUM (1)

    39 SIBUTRAMINE HYDROCHLORIDE MONOHYDRATE (1)

    40 SULPHAZINE (1)

    41 SUMATRIPTAN SUCCINATE AND SUMATRIPTAN (1)

    42 TAMSULOSIN HYDROCHLORIDE (1)

    43 TELMISARTAN, USP (1)

    44 TICAGRELOR (1)

    45 TPE ALCOHOL (1)

    46 TRIPEPTIDE, DRUG INTERMEDIATE (1)

    47 TRITYL LOSARTAN (1)

    48 Topiramate (1)

    49 VALACYCLOVIR HYDROCHLORIDE USP (HYDROUS FORM) (1)

    50 VALSARTAN USP (1)

    51 VENLAFAXINE HCL (1)

    52 VERAPAMIL HYDROCHLORIDE USP (1)

    53 VIGABATRIN (1)

    54 VIGABATRIN USP (1)

    55 ZOLPIDEM TARTRATE USP (1)

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    01 DIVI'S LABOTATORIES LTD (5)

    02 DIVIS LABORATORIES LTD (51)

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    01 India (56)

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    01 Active (42)

    02 Inactive (14)

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    01 Complete (31)

    02 Blank (25)

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    5-PHENYLHYDANTOIN

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    DIVIS LABORATORIES LT...
    Inactive
    15848
    N/A
    2002-01-31
    II
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    BOC CORE SUCCINATE (INTERMEDIATE)

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    DIVIS LABORATORIES LT...
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    20686
    N/A
    2007-07-15
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    BUPROPION HYDROCHLORIDE USP

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    DIVIS LABORATORIES LT...
    Active
    18306
    Complete
    2013-03-15
    2013-02-27
    2005-04-24
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    CAPECITABINE

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    DIVI'S LABOTATORIES L...
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    22157
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    2014-04-28
    2014-04-21
    2008-10-27
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    CARBIDOPA USP

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    DIVIS LABORATORIES LT...
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    17846
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    2012-11-23
    2012-12-06
    2004-11-20
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    DESLORATADINE

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    DIVIS LABORATORIES LT...
    Inactive
    19441
    N/A
    2006-05-17
    II
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    DEXTROMETHORPHAN BASE USP

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    DIVIS LABORATORIES LT...
    Active
    22469
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    2020-01-21
    2019-07-29
    2009-01-28
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    DEXTROMETHORPHAN HYDROBROMIDE USP

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    DIVIS LABORATORIES LT...
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    12356
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    2013-01-09
    2012-11-23
    1997-02-04
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    DILTIAZEM HYDROCHLORIDE USP

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    DIVIS LABORATORIES LT...
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    15267
    Complete
    2013-03-15
    2013-02-27
    2001-01-26
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    FOSPHENYTOIN SODIUM USP

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    DIVIS LABORATORIES LT...
    Inactive
    18806
    N/A
    2005-09-25
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