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

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    17-DEACETYLNORGESTIMATE (NORELGESTR...

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    SANOFI CHIMIE
    Inactive
    17115
    N/A
    2004-01-23
    II
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    19-NOR-ANDROSTENEDIONE (NANDROLONE...

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    ROUSSELL UCLAF
    Inactive
    2399
    N/A
    1975-02-11
    II
    Sanofi Company Banner

    BePharma 2024

    Not Confirmed

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    5,6-DIMETHOXY-1-INDANONE

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    SANYO FINE CO LTD
    Inactive
    11994
    N/A
    1996-06-04
    II
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    Not Confirmed

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    5-METHYLSULFONAMIDOINDOLE-2-CARBOXY...

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    GENZYME CORP
    Inactive
    10996
    N/A
    1994-07-21
    II
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    Not Confirmed

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    ACEBUTOLOL HYDROCHLORIDE

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    GENZYME CORP
    Inactive
    9957
    N/A
    1992-11-10
    II
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    BePharma 2024

    Not Confirmed

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    ACEBUTOLOL HYDROCHLORIDE

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    SANOFI CHIMIE
    Inactive
    9382
    N/A
    1991-10-23
    II
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    BePharma 2024

    Not Confirmed

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    ACESULFAME K (ACETOSULFAM-KGERMAN)

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    HOECHST AG
    Inactive
    3593
    N/A
    1979-06-15
    II
    Sanofi Company Banner

    BePharma 2024

    Not Confirmed

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    ACETAMINOFEN

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    RHONE POULENC RORER P...
    Inactive
    5148
    N/A
    1983-11-10
    II
    Sanofi Company Banner

    BePharma 2024

    Not Confirmed

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    ACETAMINOPHEN

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    SANOFI PHARMACEUTICAL...
    Inactive
    5048
    N/A
    1983-07-22
    II
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    Not Confirmed

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    ACETAMINOPHEN (BULK)

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    RHONE POULENC RORER P...
    Inactive
    3142
    N/A
    1978-02-01
    II
    Sanofi Company Banner

    BePharma 2024

    Not Confirmed

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    ALFUZOSIN HYDROCHLORIDE

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    SANOFI CHIMIE
    Active
    20888
    N/A
    2007-09-27
    II
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    Not Confirmed

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    ALFUZOSIN HYDROCHLORIDE DRUG SUBSTA...

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    SANOFI SYNTHELABO INC
    Inactive
    11976
    N/A
    1996-05-14
    II
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    ARTESUNATE

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    HUVEPHARMA ITALIA SRL
    Inactive
    27825
    N/A
    2013-12-16
    II
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    AVANAFIL

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    SANOFI CHIMIE
    Active
    28732
    N/A
    2014-10-07
    II
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    BECLOMETHASONE DIPROPIONATE USP

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    ROUSSELL UCLAF
    Inactive
    8036
    N/A
    1989-04-28
    II
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    Not Confirmed

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    BETAMETHASONE ACETATE

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    ROUSSELL UCLAF
    Inactive
    7716
    N/A
    1988-10-18
    II
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    BIOPAL VRO-20

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    RHONE POULENC PHARMAC...
    Inactive
    405
    N/A
    1960-10-27
    II
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    Not Confirmed

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    BULK PROTIRELIN (THYROID RELEASING ...

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    AVENTIS PHARMA DEUTSC...
    Inactive
    12272
    N/A
    1996-12-06
    II
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    Not Confirmed

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    CABAZITAXEL ACETONE SOLVATE

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    SANOFI CHIMIE
    Active
    23496
    N/A
    2010-01-29
    II
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    Festival of Biologics

    Not Confirmed

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    CHENODEOXYCHOLIC ACID

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    ROUSSEL CORP
    Inactive
    2001
    N/A
    1972-09-29
    II
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    Not Confirmed

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    CHLORAZEPATE MONOPOTASSIUM

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    SANOFI SA
    Inactive
    4252
    N/A
    1981-08-10
    II
    Sanofi Company Banner

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    Not Confirmed

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    CHLORMEZANONE

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    SANOFI SYNTHELABO INC
    Inactive
    4654
    N/A
    1982-07-27
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    CHLOROQUINE BASE AND PHOSPHATE

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    SANOFI PHARMACEUTICAL...
    Inactive
    6425
    N/A
    1986-06-11
    II
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    Not Confirmed

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    CHLORPROMAZINE HYDROCHLORIDE

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    SANOFI CHIMIE
    Active
    1516
    Complete
    2013-06-03
    2013-02-13
    1970-04-23
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    CIRAMADOL HYDROCHLORIDE

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    ROUSSELL UCLAF
    Inactive
    5418
    N/A
    1984-06-21
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    CLINDAMYCIN PHOSPHATE

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    ROUSSELL UCLAF
    Inactive
    13705
    N/A
    1998-09-01
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    CLINDAMYCIN PHOSPHATE

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    GENZYME CORP
    Inactive
    13725
    N/A
    1998-09-01
    II
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    Festival of Biologics

    Not Confirmed

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    CLOPIDOGREL BISULFATE

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    SANOFI AVENTIS CHIMIE
    Inactive
    12439
    N/A
    1997-03-06
    II
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    Not Confirmed

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    CLOPIDOGREL BISULFATE

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    SANOFI SYNTHELABO INC
    Inactive
    12460
    N/A
    1997-04-08
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    CLOPIDOGREL BISULFATE FORM I

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    CHINOIN PHARMACEUTCIA...
    Inactive
    14849
    N/A
    2000-05-04
    II
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    CLOPIDOGREL BISULFATE FORM II

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    SANOFI CHIMIE
    Active
    14809
    N/A
    2000-03-31
    II
    Sanofi Company Banner

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    Not Confirmed

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    CLOROQUINE PHOSPHATE

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    SANOFI SYNTHELABO INC
    Inactive
    3926
    N/A
    1980-07-31
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    CLOTRIMAZOLE

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    CUTTER BIOLOGICAL DIV...
    Inactive
    6729
    N/A
    1986-12-17
    II
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    Not Confirmed

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    COLCHICINE

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    ROUSSELL UCLAF
    Inactive
    5163
    N/A
    1983-12-01
    II
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    Not Confirmed

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    CORTISONE ACETATE

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    ROUSSELL UCLAF
    Inactive
    3798
    N/A
    1980-04-29
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    D-PROPOXYPHENE HYDROCHLORIDE BULK

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    SANOFI AVENTIS DEUTSC...
    Inactive
    1976
    N/A
    1972-07-24
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    DAUNORUBICIN HYDROCHLORIDE

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    RHONE POULENC RORER P...
    Inactive
    13503
    N/A
    1998-09-01
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    DELTA-5 (10)-NORANDROSTENEDIONE

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    ROUSSELL UCLAF
    Inactive
    2640
    N/A
    1976-03-18
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    DESERPIDINE

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    ROUSSELL UCLAF
    Inactive
    5528
    N/A
    1984-09-13
    II
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    Not Confirmed

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    DIATRIZOATE SODIUM USP

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    SANOFI WINTHROP INC
    Inactive
    5355
    N/A
    1984-04-11
    II
    Sanofi Company Banner

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    Not Confirmed

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    DIHYDROERGOTOXIN MESYLATE

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    SANOFI CHIMIE
    Inactive
    3169
    N/A
    1978-03-06
    II
    Sanofi Company Banner

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    Not Confirmed

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    DIHYDROSTREPTOMYCIN SULFATE

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    RHONE POULENC RORER P...
    Inactive
    13442
    N/A
    1998-09-01
    II
    Sanofi Company Banner

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    Not Confirmed

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    DIHYDROTACHYSTEROL

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    ROUSSELL UCLAF
    Inactive
    5730
    N/A
    1985-03-05
    II
    Sanofi Company Banner

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    Not Confirmed

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    DISOPYRAMIDE PHOSPHATE

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    ROUSSELL UCLAF
    Inactive
    6227
    N/A
    1986-02-26
    II
    Sanofi Company Banner

    Festival of Biologics

    Not Confirmed

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    DOBUTAMINE ISONICOTINATE/ OFF-0358-...

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    HOECHST MARION ROUSSE...
    Inactive
    12528
    N/A
    1997-05-30
    II
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    DRONEDARONE HYDROCHLORIDE

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    SANOFI CHIMIE
    Active
    18409
    N/A
    2005-06-08
    II
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    EPLIVANSERIN HEMIFUMARATE

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    SANOFI AVENTIS US LLC
    Inactive
    21815
    N/A
    2008-07-18
    II
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    ESBIOL

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    ROUSSELL UCLAF
    Inactive
    6103
    N/A
    1985-09-26
    II
    Sanofi Company Banner

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    Not Confirmed

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    ESTRADIOL

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    ROUSSELL UCLAF
    Inactive
    8819
    N/A
    1990-11-09
    II
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    Not Confirmed

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    ESTRADIOL USP

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    ROUSSELL UCLAF
    Inactive
    5686
    N/A
    1985-02-07
    II
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