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

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    • FDA
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    AMILORIDE HCL

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    SIMS
    Inactive
    7726
    N/A
    1988-10-06
    II
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    ATENOLOL

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    SOCIETA ITALIANA MEDI...
    Active
    6979
    N/A
    1987-05-05
    II
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    BETAMETHASONE

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    SOCIETA ITALIANA CORT...
    Inactive
    6018
    N/A
    1985-09-17
    II
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    BETAMETHASONE ACETATE

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    SOCIETA ITALIANA CORT...
    Inactive
    4707
    N/A
    1982-10-26
    II
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    BETAMETHASONE NA PHOSPHATE

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    SOCIETA ITALIANA CORT...
    Inactive
    4294
    N/A
    1981-09-29
    II
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    • FDA
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    BUPIVACAINE HYDROCHLORIDE

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    SOCIETA ITALIANA MEDI...
    Active
    6495
    N/A
    1986-05-23
    II
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    • FDA
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    CHLORDIAZE POXIDE & CHLORDIAZE POXI...

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    SOCIETA ITALIANA MEDI...
    Inactive
    2200
    N/A
    1973-12-12
    II
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    • FDA
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    CLONIDINE BASE

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    SOCIETA ITALIANA MEDI...
    Active
    12866
    N/A
    1998-02-09
    II
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    CLONIDINE HCL

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    SOCIETA ITALIANA MEDI...
    Active
    4493
    N/A
    1982-04-05
    II
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    CROMOLYN SODIUM

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    SOCIETA ITALIANA MEDI...
    Inactive
    10736
    N/A
    1994-02-18
    II
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    DESOXIMETASONE

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    SOCIETA ITALIANA CORT...
    Inactive
    7424
    N/A
    1988-04-05
    II
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    DEXAMETHASONE

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    SOCIETA ITALIANA CORT...
    Inactive
    6030
    N/A
    1985-09-17
    II
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    DEXAMETHASONE SODIUM PHOSPHATE

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    SOCIETA ITALIANA CORT...
    Inactive
    5971
    N/A
    1985-08-07
    II
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    • FDA
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    DIPYRIDAMOLE

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    SOCIETA ITALIANA MEDI...
    Active
    3209
    Complete
    2014-05-15
    2014-05-13
    1978-04-17
    II
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    DISOPYRAMIDE PHOSPHATE

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    SOCIETA ITALIANA MEDI...
    Inactive
    4425
    N/A
    1982-01-20
    II
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    • FDA
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    FACILITIES AND CONTROLS FOR THE PRO...

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    SOCIETA ITALIANA MEDI...
    Inactive
    4068
    N/A
    1981-01-30
    II
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    • FDA
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    FLUMETHASONE PIVALATE

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    SOCIETA ITALIANA CORT...
    Inactive
    8923
    N/A
    1991-01-16
    II
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    • FDA
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    FLUNISOLIDE

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    SOCIETA ITALIANA CORT...
    Inactive
    6811
    N/A
    1987-01-23
    II
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    FLUNISOLIDE HEMIHYDRATE

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    SOCIETA ITALIANA CORT...
    Inactive
    4774
    N/A
    1982-12-22
    II
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    • FDA
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    FLUOXETINE HCL

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    SIMS SRL
    Inactive
    11699
    N/A
    1995-10-04
    II
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    FLURANDRENOLIDE

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    SOCIETA ITALIANA CORT...
    Inactive
    4107
    N/A
    1981-03-03
    II
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    GEIBROZIL

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    SOCIETA ITALIANA MEDI...
    Active
    9058
    N/A
    1991-04-05
    II
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    HALCINONIDE

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    SOCIETA ITALIANA CORT...
    Inactive
    7448
    N/A
    1988-04-15
    II
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    • FDA
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    HYDRALAZINE CHLORIDRATE

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    SOCIETA ITALIANA MEDI...
    Inactive
    5131
    N/A
    1983-06-30
    II
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    • FDA
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    HYDROCORTISONE 17-VALERATE (THIS D ...

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    SOCIETA ITALIANA CORT...
    Inactive
    3979
    N/A
    1980-11-13
    II
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    • FDA
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    HYDROCORTISONE HEMISUCCINATE

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    SOCIETA ITALIANA CORT...
    Inactive
    6185
    N/A
    1986-01-30
    II
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    HYDROCORTISONE-17-BUTYRATE

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    SOCIETA ITALIANA CORT...
    Inactive
    4031
    N/A
    1980-12-19
    II
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    • FDA
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    ITRACONAZOLE

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    SOCIETA ITALIANA MEDI...
    Inactive
    17921
    N/A
    2004-12-20
    II
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    • FDA
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    KETOPROFEN

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    SIMS SRL
    Active
    6997
    N/A
    1987-05-22
    II
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    • FDA
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    LIDOCAINE BASE

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    SOCIETA ITALIANA MEDI...
    Active
    18318
    Complete
    2014-04-04
    2014-04-01
    2005-04-29
    II
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    LIDOCAINE BASE CRYSTALLIZED & LIDOC...

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    SIMS SRL
    Active
    4139
    N/A
    1981-03-27
    II
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    • FDA
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    MEDROXYPROGESTERONE ACETATE

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    SOCIETA ITALIANA CORT...
    Inactive
    6488
    N/A
    1986-07-18
    II
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    • FDA
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    MEGESTROL ACETATE

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    SOCIETA ITALIANA CORT...
    Inactive
    6673
    N/A
    1986-11-12
    II
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    • FDA
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    MEPIVACAINE HCl

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    SOCIETA ITALIANA MEDI...
    Active
    5164
    N/A
    1983-11-24
    II
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    • FDA
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    MESALAMINE

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    SIMS SRL
    Inactive
    18054
    N/A
    2005-02-02
    II
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    MESNA

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    SOCIETA ITALIANA MEDI...
    Inactive
    14732
    N/A
    2000-02-25
    II
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    • FDA
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    METHYLPREDNISOLONE

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    SOCIETA ITALIANA CORT...
    Inactive
    6261
    N/A
    1986-04-10
    II
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    METHYLPREDNISOLONE ACETATE

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    SOCIETA ITALIANA CORT...
    Inactive
    4634
    N/A
    1982-08-24
    II
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    METHYLPREDNISOLONE SOD. SUCCINATE (...

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    SOCIETA ITALIANA CORT...
    Inactive
    4659
    N/A
    1982-08-24
    II
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    METOPROLOL TARTRATE

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    SOCIETA ITALIANA MEDI...
    Active
    5605
    N/A
    1984-11-09
    II
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    • FDA
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    OXAPROZIN

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    SOCIETA ITALIANA MEDI...
    Inactive
    15484
    N/A
    2001-06-14
    II
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    • FDA
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    PIRFENIDONE

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    SOCIETA ITALIANA MEDI...
    Inactive
    5170
    N/A
    1983-11-24
    II
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    • FDA
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    PROPRANOLOL HYDROCHLORIDE

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    SIMS SRL
    Active
    5139
    N/A
    1983-07-20
    II
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    • FDA
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    TETRAHYDROZOLINE HCl

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    SOCIETA ITALIANA MEDI...
    Active
    5147
    N/A
    1983-10-28
    II
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    • FDA
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    TICLOPIDINE HYDROCHLORIDE

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    SOCIETA ITALIANA MEDI...
    Active
    10492
    N/A
    1993-09-15
    II
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    • FDA
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    TRIAMCINOLONE

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    SOCIETA ITALIANA CORT...
    Inactive
    6105
    N/A
    1985-10-28
    II
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    TRIAMCINOLONE DIACETATE

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    SOCIETA ITALIANA CORT...
    Inactive
    4718
    N/A
    1982-11-10
    II
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    TRIAMCINOLONE HEXACETONIDE

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    SOCIETA ITALIANA CORT...
    Inactive
    6958
    N/A
    1987-04-30
    II
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    • FDA
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    FACILITIES,PERSONAL AND GENERAL OPE...

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    SOCIETA ITALIANA CORT...
    Inactive
    3889
    N/A
    1980-06-02
    II
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    MANUFACTURING SITE, FACILITIES, PER...

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    SOCIETA ITALIANA MEDI...
    Inactive
    6734
    N/A
    1986-12-01
    II
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