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

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    01 ABACAVIR SULFATE USP (1)

    02 ACYCLOVIR USP (1)

    03 ALENDRONATE SODIUM TRIHYDRATE USP (1)

    04 ALLOPURINOL USP (1)

    05 ALPHA METHYL DOPA USP (1)

    06 ASENAPINE MALEATE (1)

    07 ATAZANAVIR SULFATE (1)

    08 ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATE USP (1)

    09 AZT (ZIDOVUDINE) (1)

    10 BALSALAZIDE DISODIUM DIHYDRATE USP (1)

    11 BREXPIPRAZOLE (1)

    12 CAPECITABINE USP (1)

    13 CLOPIDOGREL BISULPHATE USP (1)

    14 CRUDE METRONIDAZOLE (1)

    15 DIDEOXYINOSINE (1)

    16 DULOXETINE HYDROCHLORIDE USP (1)

    17 EZETIMIBE USP (1)

    18 FAMCICLOVIR USP (1)

    19 FLUCONAZOLE (1)

    20 GATIFLOXACIN HEMIHYDRATE (1)

    21 GEMFIBROZIL USP (1)

    22 GEMFIBROZIL USP (GEA PROCESS) (1)

    23 IMATINIB MESYLATE (1)

    24 IRBESARTAN USP (1)

    25 LACOSAMIDE (1)

    26 LAMIVUDINE METHANOL SOLVATE USP (1)

    27 LANTHANUM CARBONATE HYDRATE (1)

    28 LEVETIRACETAM USP (1)

    29 MESALAMINE USP (1)

    30 NADOLOL USP (1)

    31 NEFAZODONE HYDROCHLORIDE (1)

    32 OXCARBAZEPINE USP (1)

    33 PAROXETINE HYDROCHLORIDE HEMIHYDRATE USP (1)

    34 PAZOPANIB HYDROCHLORIDE (1)

    35 PIOGLITAZONE HYDROCHLORIDE USP (1)

    36 PIRFENIDONE EP (1)

    37 PONATINIB HYDROCHLORIDE (1)

    38 PROGESTERONE USP (1)

    39 QUINAPRIL HYDROCHLORIDE ACETONE SOLVATE (1)

    40 SILDENAFIL CITRATE USP (1)

    41 SITAGLIPTIN PHOSPHATE MONOHYDRATE USP (1)

    42 SODIUM VALPROATE (1)

    43 TELMISARTAN USP/EP (1)

    44 TERAZOSIN HYDROCHLORIDE DIHYDRATE USP (1)

    45 TIAGABINE HYDROCHLORIDE MONOHYDRATE USP (1)

    46 TOPIRAMATE USP (1)

    47 VALPROIC ACID USP (1)

    48 VALSARTAN USP (1)

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    ABACAVIR SULFATE USP

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    SIGNA SA DE CV
    Active
    23644
    Complete
    2014-07-15
    2014-07-07
    2010-03-19
    II
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    ACYCLOVIR USP

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    SIGNA SA DE CV
    Active
    22949
    Complete
    2014-01-03
    2013-12-11
    2009-07-16
    II
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    ALENDRONATE SODIUM TRIHYDRATE USP

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    SIGNA SA DE CV
    Inactive
    16129
    N/A
    2002-09-10
    II
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    ALLOPURINOL USP

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    SIGNA SA DE CV
    Active
    15841
    N/A
    2002-02-04
    II
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    ALPHA METHYL DOPA USP

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    SIGNA SA
    Inactive
    6363
    N/A
    1986-05-16
    II
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    ASENAPINE MALEATE

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    SIGNA SA DE CV
    Inactive
    27316
    N/A
    2013-07-26
    II
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    ATAZANAVIR SULFATE

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    SIGNA SA DE CV
    Inactive
    28565
    N/A
    2015-01-28
    II
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    ATORVASTATIN CALCIUM PROPYLENE GLYC...

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    SIGNA SA DE CV
    Active
    21574
    Complete
    2012-11-23
    2012-11-05
    2008-04-29
    II
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    AZT (ZIDOVUDINE)

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    SIGNA SA DE CV
    Inactive
    8818
    N/A
    1990-11-07
    II
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    BALSALAZIDE DISODIUM DIHYDRATE USP

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    SIGNA SA DE CV
    Active
    18894
    Complete
    2014-06-24
    2013-04-30
    2005-10-21
    II
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