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

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    7-KETOLITHOCHOLIC ACID

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    DIPHARMA FRANCIS SRL
    Active
    32475
    N/A
    2018-02-27
    II
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    AMINOCAPROIC ACID

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    DIPHARMA FRANCIS SRL
    Active
    31132
    Complete
    2017-09-21
    2017-07-25
    2016-12-14
    II
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    AMITRIPTYLINE HYDROCHLORIDE

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    DIPHARMA FRANCIS SRL
    Active
    2908
    N/A
    1977-03-18
    II
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    BENDROFLUMETHIAZIDE USP

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    DIPHARMA FRANCIS SRL
    Inactive
    6391
    N/A
    1986-05-09
    II
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    BUPROPION HCL

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    DIPHARMA FRANCIS SRL
    Active
    14534
    Complete
    2015-03-09
    2015-03-04
    1999-11-11
    II
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    BUPROPION HYDROBROMIDE

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    DIPHARMA FRANCIS SRL
    Inactive
    22720
    N/A
    2009-04-14
    II
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    CHENODEOXYCHOLIC ACID

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    DIPHARMA FRANCIS SRL
    Active
    34160
    Complete
    2020-11-10
    2020-10-29
    2019-09-30
    II
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    CHLORPROPAMIDE

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    DIPHARMA FRANCIS SRL
    Inactive
    3514
    N/A
    1979-03-02
    II
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    CILOSTAZOL

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    DIPHARMA FRANCIS SRL
    Active
    17050
    Complete
    2019-02-27
    2019-02-25
    2003-12-22
    II
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    CYCLOBENZAPRINE HCL

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    DIPHARMA FRANCIS SRL
    Active
    5864
    Complete
    2015-06-23
    2015-06-17
    1985-06-06
    II
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    CYPROHEPTADINE HCL, USP

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    DIPHARMA FRANCIS SRL
    Active
    3524
    Complete
    2013-04-23
    2013-04-09
    1979-02-08
    II
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    DAPSONE

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    DIPHARMA FRANCIS SRL
    Active
    31521
    Complete
    2020-02-04
    2019-10-30
    2017-06-22
    II
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    DEXLANSOPRAZOLE

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    DIPHARMA FRANCIS SRL
    Inactive
    23380
    N/A
    2009-12-16
    II
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    DEXLANSOPRAZOLE AMORPHOUS

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    DIPHARMA FRANCIS SRL
    Active
    32308
    Complete
    2018-04-13
    2018-01-18
    2018-01-19
    II
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    DEXLANSOPRAZOLE ANHYDROUS

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    DIPHARMA FRANCIS SRL
    Inactive
    24875
    N/A
    2011-04-15
    II
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    DEXLANSOPRAZOLE ANHYDROUS

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    DIPHARMA FRANCIS SRL
    Active
    32397
    Complete
    2018-03-09
    2018-01-18
    2018-01-19
    II
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    DIBENZOSUBERENONE

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    DIPHARMA SPA
    Inactive
    13802
    N/A
    1998-10-21
    II
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    DICLOFENAC EPOLAMINE

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    DIPHARMA FRANCIS SRL
    Inactive
    25677
    N/A
    2012-01-04
    II
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    DICLOFENAC POTASSIUM

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    DIPHARMA FRANCIS SRL
    Active
    13045
    N/A
    1998-06-26
    II
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    DICLOFENAC SODIUM EP/USP

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    DIPHARMA FRANCIS SRL
    Active
    6689
    Complete
    2013-09-28
    2013-09-24
    1986-11-20
    II
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    DOXEPIN HCl

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    DIPHARMA FRANCIS SRL
    Active
    5404
    Complete
    2014-03-31
    2014-03-24
    1984-04-10
    II
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    EFINACONAZOLE

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    DIPHARMA FRANCIS SRL
    Active
    31918
    Complete
    2017-10-10
    2017-07-25
    2017-08-02
    II
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    ENTACAPONE

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    DIPHARMA FRANCIS SRL
    Active
    22538
    N/A
    2009-02-17
    II
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    FESOTERODINE FUMARATE

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    DIPHARMA FRANCIS SRL
    Active
    25052
    Complete
    2013-02-07
    2012-11-09
    2011-06-16
    II
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    FEXOFENADINE HYDROCHLORIDE USP

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    DIPHARMA FRANCIS SRL
    Active
    16029
    N/A
    2002-06-20
    II
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    FEXOFENADINE HYDROCHLORIDE USP FORM...

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    DIPHARMA FRANCIS SRL
    Active
    28287
    Complete
    2014-10-15
    2014-05-22
    2014-06-13
    II
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    FEXOFENADINE HYDROCHLORIDE USP FORM...

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    DIPHARMA FRANCIS SRL
    Active
    28612
    Complete
    2015-01-05
    2014-10-09
    2014-11-05
    II
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    GILBENCLAMIDE/GLYBURIDE

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    DIPHARMA FRANCIS SRL
    Active
    7678
    N/A
    1988-09-16
    II
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    GLYCERIN TRINITRATE (NITROGLYCERIN-...

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    DIPHARMA FRANCIS SRL
    Active
    3731
    Complete
    2015-06-24
    2014-10-09
    1980-02-07
    II
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    GLYCERYL TRINITRATE SOLUTION

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    DIPHARMA FRANCIS SRL
    Active
    24107
    N/A
    2010-08-31
    II
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    HYDROFLUMETHIAZIDE USP

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    DIPHARMA FRANCIS SPA
    Inactive
    4537
    N/A
    1982-04-07
    II
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    IBUPROFEN LYSINE SALT

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    DIPHARMA FRANCIS SRL
    Active
    21444
    N/A
    2008-03-20
    II
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    ISOSORBIDE DINITRATE (ISDN)

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    DIPHARMA FRANCIS SRL
    Active
    3725
    Complete
    2016-06-15
    2016-02-25
    1980-02-07
    II
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    ISOSORBIDE-5-MONONITRATE (5-ISMN)

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    DIPHARMA FRANCIS SRL
    Active
    6778
    Complete
    2013-01-15
    2012-12-24
    1987-01-09
    II
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    MANDELATE SALT, INTERMEDIATE

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    DIPHARMA SPA
    Inactive
    17753
    N/A
    2004-10-14
    II
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    MIGLUSTAT

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    DIPHARMA SA
    Active
    29329
    Complete
    2015-10-14
    2015-05-07
    2015-06-09
    II
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    MODAFINIL USP

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    DIPHARMA FRANCIS SRL
    Active
    16250
    Complete
    2016-07-28
    2016-07-05
    2002-11-19
    II
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    NIFEDIPINE USP

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    DIPHARMA FRANCIS SRL
    Active
    6505
    Complete
    2016-03-25
    2016-02-25
    1986-07-23
    II
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      NITISINONE

      PDF Supplier PDF
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      DIPHARMA SA
      Active
      36026
      Complete
      2021-09-21
      2021-08-02
      2021-07-31
      II
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      NORTRIPTYLINE HCL

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      DIPHARMA FRANCIS SRL
      Active
      7846
      Complete
      2018-12-28
      2015-04-09
      1988-12-29
      II
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      PIRFENIDONE

      PDF Supplier PDF
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      DIPHARMA FRANCIS SRL
      Active
      32224
      Complete
      2018-11-13
      2018-10-11
      2018-04-24
      II
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      PIROXICAM

      PDF Supplier PDF
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      DIPHARMA FRANCIS SRL
      Active
      7472
      Complete
      2014-04-09
      2013-09-19
      1988-05-11
      II
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      PROTRIPTYLINE HYDROCHLORIDE

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      DIPHARMA FRANCIS SRL
      Active
      20365
      N/A
      2007-03-22
      II
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      RUFINAMIDE USP

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      DIPHARMA FRANCIS SRL
      Active
      25676
      Complete
      2013-02-07
      2012-11-09
      2012-01-04
      II
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      SAPROPTERIN DIHYDROCHLORIDE

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      DIPHARMA SA
      Active
      26682
      Complete
      2014-03-04
      2013-09-23
      2012-12-06
      II
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        SAPROPTERIN DIHYDROCHLORIDE (NEW PR...

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        DIPHARMA SA
        Active
        34926
        Complete
        2020-08-26
        2020-06-15
        2020-06-17
        II
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        SELEGILINE BASE

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        DIPHARMA FRANCIS SRL
        Active
        30957
        Complete
        2017-10-05
        2017-07-25
        2017-06-30
        II
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        SELEGILINE HYDROCHLORIDE

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        DIPHARMA FRANCIS SRL
        Active
        9275
        Complete
        2014-02-07
        2014-02-03
        1991-08-05
        II
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        SPIRONOLACTONE

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        DIPHARMA FRANCIS SRL
        Inactive
        3052
        N/A
        1977-10-18
        II
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        SULINDAC, MANFACTURED IN MERETO DI ...

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        DIPHARMA SPA
        Inactive
        13089
        N/A
        1998-07-21
        II
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