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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Dipharma

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    Dipharma
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    Italy
    Address
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    Via Bissone, 5 20021 Baranzate (MI)
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    + 39 02 38228.1
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    enquiries@pharmacompass.com
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    • FDA
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    Isosorbide Mononitrate

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    USDMF

    Found USDMF

    6778
    Active
    ISOSORBIDE-5-MONONITRATE (5-ISMN)
    1987-01-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2007-261 - Rev 02
    Valid
    Isosorbide mononitrate, diluted, 90...
    2021-12-01
    Japanese DMF

    Found JDMF

    218MF10745
    Isosorbide mononitrate at Via Bisso...
    2006-09-06
    Written Confirmation

    Close WC

    Application Number
    6778
    R1-CEP 2007-261 - Rev 02
    218MF10745
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ISOSORBIDE-5-MONONITRATE (5-ISMN)
    Isosorbide mononitrate, diluted, 90...
    Isosorbide mononitrate at Via Bisso...
    Issue/Submission Date
    1987-01-09
    2021-12-01
    2006-09-06
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    Selegiline Hydrochloride

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    USDMF

    Found USDMF

    9275
    Active
    SELEGILINE HYDROCHLORIDE
    1991-08-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-075 - Rev 03
    Valid
    Selegiline hydrochloride
    2013-05-03
    Japanese DMF

    Found JDMF

    219MF10340
    Selegiline hydrochloride at Via Bis...
    2007-11-21
    Written Confirmation

    Close WC

    Application Number
    9275
    R1-CEP 2001-075 - Rev 03
    219MF10340
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SELEGILINE HYDROCHLORIDE
    Selegiline hydrochloride
    Selegiline hydrochloride at Via Bis...
    Issue/Submission Date
    1991-08-05
    2013-05-03
    2007-11-21
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    Amitriptyline Hydrochloride

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    USDMF

    Found USDMF

    2908
    Active
    AMITRIPTYLINE HYDROCHLORIDE
    1977-03-18
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-281 - Rev 00
    Valid
    Amitriptyline hydrochloride
    2021-03-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    2908
    R1-CEP 2013-281 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    AMITRIPTYLINE HYDROCHLORIDE
    Amitriptyline hydrochloride
    Issue/Submission Date
    1977-03-18
    2021-03-23
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    • FDA
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    Cyclobenzaprine

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    USDMF

    Found USDMF

    5864
    Active
    CYCLOBENZAPRINE HCL
    1985-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    306MF10003
    Cyclobenzaprine Hydrochloride at Vi...
    2024-01-11
    Written Confirmation

    Close WC

    Application Number
    5864
    306MF10003
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CYCLOBENZAPRINE HCL
    Cyclobenzaprine Hydrochloride at Vi...
    Issue/Submission Date
    1985-06-06
    2024-01-11
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    • FDA
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    Cyproheptadine Hydrochloride

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    USDMF

    Found USDMF

    3524
    Active
    CYPROHEPTADINE HCL, USP
    1979-02-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10221
    Cyproheptadine hydrochloride hydrat...
    2008-11-04
    Written Confirmation

    Close WC

    Application Number
    3524
    220MF10221
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CYPROHEPTADINE HCL, USP
    Cyproheptadine hydrochloride hydrat...
    Issue/Submission Date
    1979-02-08
    2008-11-04
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    • FDA
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    Entacapone

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    USDMF

    Found USDMF

    22538
    Active
    ENTACAPONE
    2009-02-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10070
    Entacapone at Via Bissone, 5, 20021...
    2015-03-12
    Written Confirmation

    Close WC

    Application Number
    22538
    227MF10070
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ENTACAPONE
    Entacapone at Via Bissone, 5, 20021...
    Issue/Submission Date
    2009-02-17
    2015-03-12
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    Fexofenadine Hydrochloride

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    USDMF

    Found USDMF

    16029
    Active
    FEXOFENADINE HYDROCHLORIDE USP
    2002-06-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10070
    Fexofenadine hydrochloride at Via B...
    2016-03-02
    Written Confirmation

    Close WC

    Application Number
    16029
    228MF10070
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FEXOFENADINE HYDROCHLORIDE USP
    Fexofenadine hydrochloride at Via B...
    Issue/Submission Date
    2002-06-20
    2016-03-02
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    • FDA
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    Glibenclamide

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    USDMF

    Found USDMF

    7678
    Active
    GILBENCLAMIDE/GLYBURIDE
    1988-09-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10231
    Glibenclamide at Via Bissone, 5, 20...
    2012-12-18
    Written Confirmation

    Close WC

    Application Number
    7678
    224MF10231
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GILBENCLAMIDE/GLYBURIDE
    Glibenclamide at Via Bissone, 5, 20...
    Issue/Submission Date
    1988-09-16
    2012-12-18
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    • FDA
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    Isosorbide Dinitrate

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    USDMF

    Found USDMF

    3725
    Active
    ISOSORBIDE DINITRATE (ISDN)
    1980-02-07
    CEP/COS

    Found CEP/COS

    R1-CEP 2013-295 - Rev 00
    Valid
    Isosorbide dinitrate, diluted, 25% ...
    2022-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    3725
    R1-CEP 2013-295 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ISOSORBIDE DINITRATE (ISDN)
    Isosorbide dinitrate, diluted, 25% ...
    Issue/Submission Date
    1980-02-07
    2022-02-09
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    • FDA
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    Nifedipine

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    USDMF

    Found USDMF

    6505
    Active
    NIFEDIPINE USP
    1986-07-23
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-447 - Rev 02
    Valid
    Nifedipine
    2019-01-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6505
    R1-CEP 2001-447 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    NIFEDIPINE USP
    Nifedipine
    Issue/Submission Date
    1986-07-23
    2019-01-24
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    Nortriptyline

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    USDMF

    Found USDMF

    7846
    Active
    NORTRIPTYLINE HCL
    1988-12-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10264
    Nortriptyline hydrochloride at Via ...
    2007-08-16
    Written Confirmation

    Close WC

    Application Number
    7846
    219MF10264
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NORTRIPTYLINE HCL
    Nortriptyline hydrochloride at Via ...
    Issue/Submission Date
    1988-12-29
    2007-08-16
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    • FDA
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    Pirfenidone

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    USDMF

    Found USDMF

    32224
    Active
    PIRFENIDONE
    2018-04-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10023
    Pirfenidone at Via Bissone, 5, 2002...
    2019-02-05
    Written Confirmation

    Close WC

    Application Number
    32224
    231MF10023
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PIRFENIDONE
    Pirfenidone at Via Bissone, 5, 2002...
    Issue/Submission Date
    2018-04-24
    2019-02-05
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    • FDA
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    Selegiline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    30957
    Active
    SELEGILINE BASE
    2017-06-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2023-056 - Rev 00
    Valid
    Selegiline hydrochloride, S2
    2023-04-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30957
    R0-CEP 2023-056 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SELEGILINE BASE
    Selegiline hydrochloride, S2
    Issue/Submission Date
    2017-06-30
    2023-04-20
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    • FDA
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    Tramadol Hydrochloride

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    USDMF

    Found USDMF

    15545
    Active
    TRAMADOL HCL
    2001-07-25
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-105 - Rev 00
    Valid
    Tramadol hydrochloride
    2016-01-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15545
    R1-CEP 2002-105 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    TRAMADOL HCL
    Tramadol hydrochloride
    Issue/Submission Date
    2001-07-25
    2016-01-12
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    • FDA
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    Ursodeoxycholic Acid

    PDF Supplier PDF
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    USDMF

    Found USDMF

    11379
    Active
    URSODEOXYCHOLIC ACID
    1995-03-13
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-108 - Rev 06
    Valid
    Ursodeoxycholic acid
    2019-07-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11379
    R1-CEP 2004-108 - Rev 06
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    URSODEOXYCHOLIC ACID
    Ursodeoxycholic acid
    Issue/Submission Date
    1995-03-13
    2019-07-11
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    • FDA
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    Zonisamide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17303
    Active
    ZONISAMIDE
    2004-04-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10153
    Zonisamide at Via Bissone, 5, 20021...
    2017-08-04
    Written Confirmation

    Close WC

    Application Number
    17303
    229MF10153
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ZONISAMIDE
    Zonisamide at Via Bissone, 5, 20021...
    Issue/Submission Date
    2004-04-02
    2017-08-04
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    • FDA
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    7-Ketolithocholic acid

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    USDMF

    Found USDMF

    32475
    Active
    7-KETOLITHOCHOLIC ACID
    2018-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32475
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    7-KETOLITHOCHOLIC ACID
    Issue/Submission Date
    2018-02-27
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    Aminocaproic Acid

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    USDMF

    Found USDMF

    31132
    Active
    AMINOCAPROIC ACID
    2016-12-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31132
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    AMINOCAPROIC ACID
    Issue/Submission Date
    2016-12-14
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    Amitriptyline Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-193 - Rev 00
    Valid
    Amitriptyline hydrochloride, Proces...
    2020-06-30
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-193 - Rev 00
    Status
    Valid
     
    Filing Details
    Amitriptyline hydrochloride, Proces...
    Issue/Submission Date
    2020-06-30
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    • FDA
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    Bupropion Hydrochloride

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    USDMF

    Found USDMF

    14534
    Active
    BUPROPION HCL
    1999-11-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14534
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BUPROPION HCL
    Issue/Submission Date
    1999-11-11
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    Chenodeoxycholic Acid

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    USDMF

    Found USDMF

    34160
    Active
    CHENODEOXYCHOLIC ACID
    2019-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34160
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CHENODEOXYCHOLIC ACID
    Issue/Submission Date
    2019-09-30
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    Cholic Acid

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-252 - Rev 00
    Valid
    Cholic acid
    2015-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-252 - Rev 00
    Status
    Valid
     
    Filing Details
    Cholic acid
    Issue/Submission Date
    2015-07-08
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    Cilostazol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17050
    Active
    CILOSTAZOL
    2003-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17050
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CILOSTAZOL
    Issue/Submission Date
    2003-12-22
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    Dapsone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31521
    Active
    DAPSONE
    2017-06-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31521
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DAPSONE
    Issue/Submission Date
    2017-06-22
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    Dexlansoprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32308
    Active
    DEXLANSOPRAZOLE AMORPHOUS
    2018-01-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32308
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXLANSOPRAZOLE AMORPHOUS
    Issue/Submission Date
    2018-01-19
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    Dexlansoprazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    32397
    Active
    DEXLANSOPRAZOLE ANHYDROUS
    2018-01-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32397
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DEXLANSOPRAZOLE ANHYDROUS
    Issue/Submission Date
    2018-01-19
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    Diclofenac Potassium

    PDF Supplier PDF
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    USDMF

    Found USDMF

    13045
    Active
    DICLOFENAC POTASSIUM
    1998-06-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13045
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DICLOFENAC POTASSIUM
    Issue/Submission Date
    1998-06-26
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    Diclofenac Sodium

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    USDMF

    Found USDMF

    6689
    Active
    DICLOFENAC SODIUM EP/USP
    1986-11-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    6689
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DICLOFENAC SODIUM EP/USP
    Issue/Submission Date
    1986-11-20
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    Doxepin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    5404
    Active
    DOXEPIN HCl
    1984-04-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5404
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOXEPIN HCl
    Issue/Submission Date
    1984-04-10
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    Efinaconazole

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    31918
    Active
    EFINACONAZOLE
    2017-08-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31918
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    EFINACONAZOLE
    Issue/Submission Date
    2017-08-02
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    Fesoterodine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    25052
    Active
    FESOTERODINE FUMARATE
    2011-06-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25052
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FESOTERODINE FUMARATE
    Issue/Submission Date
    2011-06-16
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    Fexofenadine Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    28287
    Active
    FEXOFENADINE HYDROCHLORIDE USP FORM...
    2014-06-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28287
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FEXOFENADINE HYDROCHLORIDE USP FORM...
    Issue/Submission Date
    2014-06-13
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    Fexofenadine Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    28612
    Active
    FEXOFENADINE HYDROCHLORIDE USP FORM...
    2014-11-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28612
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FEXOFENADINE HYDROCHLORIDE USP FORM...
    Issue/Submission Date
    2014-11-05
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    Ibuprofen Lysinate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    21444
    Active
    IBUPROFEN LYSINE SALT
    2008-03-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21444
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    IBUPROFEN LYSINE SALT
    Issue/Submission Date
    2008-03-20
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    Isosorbide Dinitrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-298 - Rev 00
    Valid
    Isosorbide dinitrate, diluted, 40% ...
    2022-02-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2013-298 - Rev 00
    Status
    Valid
     
    Filing Details
    Isosorbide dinitrate, diluted, 40% ...
    Issue/Submission Date
    2022-02-09
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    Isosorbide Mononitrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-271 - Rev 02
    Valid
    Isosorbide mononitrate, diluted, 70...
    2021-12-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-271 - Rev 02
    Status
    Valid
     
    Filing Details
    Isosorbide mononitrate, diluted, 70...
    Issue/Submission Date
    2021-12-01
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    Isosorbide Mononitrate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2007-277 - Rev 02
    Valid
    Isosorbide mononitrate, diluted, 80...
    2021-12-01
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2007-277 - Rev 02
    Status
    Valid
     
    Filing Details
    Isosorbide mononitrate, diluted, 80...
    Issue/Submission Date
    2021-12-01
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    Miglustat

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29329
    Active
    MIGLUSTAT
    2015-06-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    29329
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MIGLUSTAT
    Issue/Submission Date
    2015-06-09
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    Modafinil

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    16250
    Active
    MODAFINIL USP
    2002-11-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    16250
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MODAFINIL USP
    Issue/Submission Date
    2002-11-19
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    Nifedipine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    CEP 2023-284 - Rev 00
    Valid
    Nifedipine, S2
    2024-01-23
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    CEP 2023-284 - Rev 00
    Status
    Valid
     
    Filing Details
    Nifedipine, S2
    Issue/Submission Date
    2024-01-23
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      Nitisinone

      PDF Supplier PDF
      URL Supplier Web Content
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      USDMF

      Found USDMF

      36026
      Active
      NITISINONE
      2021-07-31
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      36026
      Status
      Active
      Fees Unpaid
      Reviewed
       
      Filing Details
      NITISINONE
      Issue/Submission Date
      2021-07-31
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      • FDA
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      Nitroglycerin

      PDF Supplier PDF
      URL Supplier Web Content
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      See Less

      USDMF

      Found USDMF

      3731
      Active
      GLYCERIN TRINITRATE (NITROGLYCERIN-...
      1980-02-07
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      3731
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      GLYCERIN TRINITRATE (NITROGLYCERIN-...
      Issue/Submission Date
      1980-02-07
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      Nitroglycerin

      PDF Supplier PDF
      URL Supplier Web Content
      See all info for this product

      See Less

      USDMF

      Found USDMF

      24107
      Active
      GLYCERYL TRINITRATE SOLUTION
      2010-08-31
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      24107
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      GLYCERYL TRINITRATE SOLUTION
      Issue/Submission Date
      2010-08-31
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      Piroxicam

      PDF Supplier PDF
      URL Supplier Web Content
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      USDMF

      Found USDMF

      7472
      Active
      PIROXICAM
      1988-05-11
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      7472
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      PIROXICAM
      Issue/Submission Date
      1988-05-11
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      Protriptyline

      PDF Supplier PDF
      URL Supplier Web Content
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      USDMF

      Found USDMF

      20365
      Active
      PROTRIPTYLINE HYDROCHLORIDE
      2007-03-22
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      20365
      Status
      Active
      Fees Paid
      N/A
       
      Filing Details
      PROTRIPTYLINE HYDROCHLORIDE
      Issue/Submission Date
      2007-03-22
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      • FDA
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      Rufinamide

      PDF Supplier PDF
      URL Supplier Web Content
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      See Less

      USDMF

      Found USDMF

      25676
      Active
      RUFINAMIDE USP
      2012-01-04
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      25676
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      RUFINAMIDE USP
      Issue/Submission Date
      2012-01-04
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      Sapropterin Hydrochloride

      PDF Supplier PDF
      URL Supplier Web Content
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      USDMF

      Found USDMF

      26682
      Active
      SAPROPTERIN DIHYDROCHLORIDE
      2012-12-06
      CEP/COS

      Close CEP/COS

      Japanese DMF

      Close JDMF

      Written Confirmation

      Close WC

      Application Number
      26682
      Status
      Active
      Fees Paid
      Reviewed
       
      Filing Details
      SAPROPTERIN DIHYDROCHLORIDE
      Issue/Submission Date
      2012-12-06
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        Sapropterin Hydrochloride

        PDF Supplier PDF
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        USDMF

        Found USDMF

        34926
        Active
        SAPROPTERIN DIHYDROCHLORIDE (NEW PR...
        2020-06-17
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        34926
        Status
        Active
        Fees Unpaid
        Reviewed
         
        Filing Details
        SAPROPTERIN DIHYDROCHLORIDE (NEW PR...
        Issue/Submission Date
        2020-06-17
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        Triamterene

        PDF Supplier PDF
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        USDMF

        Found USDMF

        3516
        Active
        TRIAMTERENE USP
        1979-03-30
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        3516
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        TRIAMTERENE USP
        Issue/Submission Date
        1979-03-30
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        Vortioxetine Hydrobromide

        PDF Supplier PDF
        URL Supplier Web Content
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        USDMF

        Found USDMF

        31618
        Active
        VORTIOXETINE HYDROBROMIDE MONOHYDRA...
        2017-04-06
        CEP/COS

        Close CEP/COS

        Japanese DMF

        Close JDMF

        Written Confirmation

        Close WC

        Application Number
        31618
        Status
        Active
        Fees Paid
        Reviewed
         
        Filing Details
        VORTIOXETINE HYDROBROMIDE MONOHYDRA...
        Issue/Submission Date
        2017-04-06
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