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

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    01 1ALPROSTADIL

    02 1APOMORPHINE HYDROCHLORIDE

    03 1BIMATOPROST

    04 1BIMATOPROST-FORM I

    05 1CARBOPROST TROMETHAMINE

    06 1CLOBAZAM

    07 1DESOXIMETASONE USP, MICRONIZED

    08 1DEXAMETHASONE

    09 1DEXAMETHASONE ACETATE ANHYDROUS USP

    10 1DEXAMETHASONE SODIUM PHOSPHATE

    11 1DINOPROSTONE (PROSTAGLANDIN E2)

    12 1EPOPROSTENAL SODIUM DRUG SUBSTANCE

    13 1FLUOROMETHOLONE

    14 1FUROSEMIDE (BULK)

    15 1GLIMEPIRIDE (PROCESS 2)

    16 1HYDROCORTISONE

    17 1HYDROCORTISONE USP

    18 1HYDROXOCOBALAMIN

    19 1HYDROXOCOBALAMIN ACETATE PH.EUR.,JP,PYROGEN-FREE

    20 1HYDROXYCHLOROQUINE SULFATE

    21 1ILOPROST

    22 1IRBESARTAN DRUG SUBSTANCE

    23 1LATANOPROST

    24 1METHYLPREDNISOLONE

    25 1METHYLPREDNISOLONE HEMISUCCINATE

    26 1NALBUPHINE HYDROCHLORIDE

    27 1NALOXONE HYDROCHLORIDE

    28 1NALTREXONE HYDROCHLORIDE

    29 1OLMESARTAN MEDOXOMIL USP

    30 1PREDNISOLONE

    31 1PREDNISOLONE ACETATE

    32 1PREDNISOLONE SODIUM PHOSPHATE

    33 1PREDNISONE

    34 1RIFAMPIN, USP

    35 1RIFAXIMIN

    36 1SELEGILINE HYDROCHLORIDE

    37 1SEVELAMER HYDROCHLORIDE

    38 1SODIUM CROMOGLICATE

    39 1SPIRONOLACTONE

    40 2TRAVOPROST

    41 1TREPROSTINIL SODIUM

    42 1TRIAMCINOLONE ACETONIDE

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    01

    Alprostadil

    France
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    CPhI Worldwide, Milan
    Booth #5A113
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 10948

    Submission : 1994-06-20

    Status : Active

    Type : II

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    02

    Apomorphine Hydrochloride

    France
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    CPhI Worldwide, Milan
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2020-09-25

    Pay. Date : 2020-09-21

    DMF Number : 12818

    Submission : 1998-01-07

    Status : Active

    Type : II

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    03

    Bimatoprost

    France
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    CPhI Worldwide, Milan
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-05-20

    Pay. Date : 2015-12-08

    DMF Number : 29560

    Submission : 2015-07-17

    Status : Active

    Type : II

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    04

    Bimatoprost-form I

    France
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    CPhI Worldwide, Milan
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 34360

    Submission : 2019-12-10

    Status : Active

    Type : II

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    05

    Carboprost Tromethamine

    France
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-03-01

    Pay. Date : 2022-02-11

    DMF Number : 35412

    Submission : 2021-11-15

    Status : Active

    Type : II

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    06

    Clobazam

    France
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    CPhI Worldwide, Milan
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-02-27

    Pay. Date : 2013-02-13

    DMF Number : 18340

    Submission : 2005-05-09

    Status : Active

    Type : II

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    07

    Desoximetasone Usp, Micronized

    France
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    CPhI Worldwide, Milan
    Booth #5A113
    • fda
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-08

    Pay. Date : 2012-11-30

    DMF Number : 14852

    Submission : 2000-04-28

    Status : Active

    Type : II

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    08

    Dexamethasone

    France
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    CPhI Worldwide, Milan
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    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-09-28

    Pay. Date : 2013-09-18

    DMF Number : 1748

    Submission : 1971-06-21

    Status : Active

    Type : II

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    09

    Dexamethasone Acetate Anhydrous Usp

    France
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    CPhI Worldwide, Milan
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 2736

    Submission : 1976-07-19

    Status : Active

    Type : II

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    10

    Dexamethasone Sodium Phosphate

    France
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    DMF Review : Complete

    Rev. Date : 2013-01-28

    Pay. Date : 2013-01-16

    DMF Number : 3963

    Submission : 1980-10-10

    Status : Active

    Type : II

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    Contact Sanofi Active Ingredient Solutions and get a quotation

    Sanofi Active Ingredient Solutions is a supplier offers 127 products (APIs, Excipients or Intermediates).

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