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

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    FDC Limited
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    India
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    FDC LIMITEDB-8, MIDC AreaWaluj - 431 136Dist. AurangabadMaharashtra
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    0240 - 2554407 / 2554299 / 2554967
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    enquiries@pharmacompass.com
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    https://www.fdcindia.com/
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    ALBUTEROL SULFATE USP

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    FDC LTD
    Active
    7809
    Complete
    2014-06-05
    2014-05-28
    1988-12-12
    II
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    BRIMONIDINE TARTRATE USP

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    FDC LTD
    Active
    20855
    N/A
    2007-09-17
    II
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    CINNARIZINE

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    FDC LTD
    Active
    31934
    N/A
    2017-09-07
    II
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    DANTROLENE SODIUM

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    FDC LTD
    Inactive
    17446
    N/A
    2004-05-27
    II
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    DIAZEPAM U.S.P. XXI

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    FDC PRIVATE LTD
    Inactive
    7025
    N/A
    1987-06-18
    II
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    DORZOLAMIDE HYDROCHLORIDE USP

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    FDC LTD
    Inactive
    20856
    N/A
    2007-09-17
    II
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    DORZOLAMIDE HYDROCHLORIDE USP (PROC...

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    FDC LTD
    Active
    33576
    Complete
    2019-08-26
    2019-06-21
    2019-04-02
    II
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    ECONAZOLE NITRATE USP

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    FDC LTD
    Active
    10456
    N/A
    1993-08-09
    II
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    FLUCONAZOLE

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    FDC LTD
    Inactive
    16632
    N/A
    2003-06-12
    II
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    FLURBIPROFEN USP

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    FDC LTD
    Active
    8219
    N/A
    1989-09-07
    II
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    KETOCONAZOLE

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    FDC LTD
    Inactive
    16802
    N/A
    2003-08-27
    II
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    LATANOPROST USP

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    FDC LTD
    Active
    23813
    N/A
    2010-05-18
    II
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    LEVALBUTEROL HYDROCHLORIDE

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    FDC LTD
    Inactive
    21394
    N/A
    2008-03-05
    II
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    METAXALONE

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    FDC LTD
    Inactive
    16449
    N/A
    2003-03-04
    II
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    METRONIDAZOLE U.S.P. XXI

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    FDC PRIVATE LTD
    Inactive
    7024
    N/A
    1987-06-18
    II
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    MICONAZOLE NITRATE USP

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    FDC LTD
    Active
    7376
    Complete
    2023-03-31
    2023-03-29
    1988-03-04
    II
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    MICONAZOLE USP

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    FDC LTD
    Inactive
    24879
    N/A
    2011-04-21
    II
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    OLOPATADINE HYDROCHLORIDE USP

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    FDC LTD
    Active
    29464
    Complete
    2016-07-28
    2015-09-21
    2015-06-23
    II
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    TELMISARTAN USP

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    FDC LTD
    Inactive
    31823
    N/A
    2017-08-01
    II
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    TIMOLOL MALEATE USP

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    FDC LTD
    Active
    9839
    Complete
    2012-10-25
    2012-11-27
    1992-07-27
    II
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    BRINZOLAMIDE USP

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    FDC LTD
    Active
    39512
    N/A
    2024-03-06
    II
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    FACILS & GEN. OPERATING PROCEDS. FO...

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    FDC PRIVATE LTD
    Inactive
    4951
    N/A
    1983-05-25
    II
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    MANUFACTURING SITE, FACILITIES, PER...

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    FDC PRIVATE LTD
    Inactive
    7102
    N/A
    1987-08-07
    II
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