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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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    • FDA
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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

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

    PDF Supplier PDF
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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

    PDF Supplier PDF
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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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    BREXPIPRAZOLE

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    SIGNA SA DE CV
    Active
    33560
    Complete
    2019-05-03
    2019-02-15
    2019-03-11
    II
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    CAPECITABINE USP

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    SIGNA SA DE CV
    Inactive
    30543
    N/A
    2016-06-23
    II
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    CLOPIDOGREL BISULPHATE USP

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    SIGNA SA DE CV
    Active
    15721
    N/A
    2001-11-13
    II
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    CRUDE METRONIDAZOLE

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    SIGNA SA
    Inactive
    4025
    N/A
    1981-01-06
    II
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    DIDEOXYINOSINE

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    SIGNA SA DE CV
    Inactive
    17413
    N/A
    2004-05-26
    II
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    DULOXETINE HYDROCHLORIDE USP

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    SIGNA SA DE CV
    Active
    21833
    Complete
    2017-06-16
    2017-05-19
    2008-07-30
    II
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    EZETIMIBE USP

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    SIGNA SA DE CV
    Inactive
    26637
    N/A
    2012-12-10
    II
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    FAMCICLOVIR USP

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    SIGNA SA DE CV
    Active
    22713
    N/A
    2009-04-09
    II
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    FLUCONAZOLE

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    SIGNA SA DE CV
    Inactive
    16420
    N/A
    2003-02-10
    II
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    • FDA
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    GATIFLOXACIN HEMIHYDRATE

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    SIGNA SA DE CV
    Inactive
    30999
    N/A
    2016-12-27
    II
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    GEIBROZIL USP

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    SIGNA SA DE CV
    Inactive
    15412
    N/A
    2001-05-03
    II
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    GEIBROZIL USP (GEA PROCESS)

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    SIGNA SA DE CV
    Inactive
    26146
    N/A
    2011-04-18
    II
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    IMATINIB MESYLATE

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    SIGNA SA DE CV
    Inactive
    28192
    N/A
    2016-06-28
    II
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    IRBESARTAN USP

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    SIGNA SA DE CV
    Inactive
    23347
    N/A
    2009-12-07
    II
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    • FDA
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    LACOSAMIDE

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    SIGNA SA DE CV
    Active
    26484
    Complete
    2013-04-26
    2012-11-13
    2012-09-27
    II
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    LAMIVUDINE METHANOL SOLVATE USP

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    SIGNA SA DE CV
    Active
    22931
    N/A
    2009-07-08
    II
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    LANTHANUM CARBONATE HYDRATE

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    SIGNA SA DE CV
    Inactive
    28008
    N/A
    2014-06-05
    II
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    LEVETIRACETAM USP

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    SIGNA SA DE CV
    Inactive
    20412
    N/A
    2007-04-04
    II
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    MESALAMINE USP

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    SIGNA SA DE CV
    Inactive
    29676
    N/A
    2016-01-12
    II
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    NADOLOL USP

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    SIGNA SA DE CV
    Active
    7426
    Complete
    2015-02-24
    2014-08-07
    1988-04-11
    II
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    • FDA
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    NEFAZODONE HYDROCHLORIDE

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    SIGNA SA DE CV
    Inactive
    16387
    N/A
    2003-01-28
    II
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    • FDA
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    OXCARBAZEPINE USP

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    SIGNA SA DE CV
    Active
    17988
    Complete
    2018-02-28
    2017-09-28
    2005-01-12
    II
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    • FDA
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    PAROXETINE HYDROCHLORIDE HEMIHYDRAT...

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    SIGNA SA DE CV
    Active
    28763
    Complete
    2015-05-31
    2014-10-29
    2014-12-22
    II
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    • FDA
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    PAZOPANIB HYDROCHLORIDE

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    ZHEJIANG LEPU PHARMAC...
    Active
    34146
    Complete
    2020-06-16
    2019-09-13
    2019-11-01
    II
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    • FDA
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    PIOGLITAZONE HYDROCHLORIDE USP

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    SIGNA SA DE CV
    Inactive
    21603
    N/A
    2008-05-08
    II
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    • FDA
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    PIRFENIDONE EP

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    SIGNA SA DE CV
    Active
    15168
    Complete
    2018-07-13
    2018-05-25
    2000-11-30
    II
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    PONATINIB HYDROCHLORIDE

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    ZHEJIANG LEPU PHARMAC...
    Active
    35413
    Complete
    2021-01-29
    2020-11-27
    2020-12-16
    II
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    • FDA
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    PROGESTERONE USP

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    SIGNA SA DE CV
    Inactive
    26640
    N/A
    2012-12-21
    II
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    • FDA
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    QUINAPRIL HYDROCHLORIDE ACETONE SOL...

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    SIGNA SA DE CV
    Inactive
    15619
    N/A
    2001-09-14
    II
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    • FDA
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    SILDENAFIL CITRATE USP

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    SIGNA SA DE CV
    Inactive
    22599
    N/A
    2009-03-06
    II
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    • FDA
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    SITAGLIPTIN PHOSPHATE MONOHYDRATE U...

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    SIGNA SA DE CV
    Active
    32298
    Complete
    2018-06-12
    2017-12-05
    2018-03-30
    II
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    • FDA
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    SODIUM VALPROATE

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    SIGNA SA DE CV
    Inactive
    17225
    N/A
    2004-03-05
    II
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    • FDA
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    TELMISARTAN USP/EP

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    SIGNA SA DE CV
    Inactive
    25742
    N/A
    2012-01-25
    II
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    • FDA
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    TERAZOSIN HYDROCHLORIDE DIHYDRATE U...

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    SIGNA SA DE CV
    Active
    18268
    Complete
    2015-12-11
    2014-04-04
    2005-04-11
    II
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    • FDA
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    TIAGABINE HYDROCHLORIDE MONOHYDRATE...

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    SIGNA SA DE CV
    Inactive
    27380
    N/A
    2013-12-20
    II
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    • FDA
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    TOPIRAMATE USP

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    SIGNA SA DE CV
    Inactive
    21657
    N/A
    2008-05-26
    II
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    • FDA
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    VALPROIC ACID USP

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    SIGNA SA DE CV
    Inactive
    17224
    N/A
    2004-03-05
    II
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    VALSARTAN USP

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    SIGNA SA DE CV
    Inactive
    23150
    N/A
    2009-10-05
    II
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