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    CordenPharma
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    +1 781 305 3332
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    • FDA
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    Fenofibrate

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    USDMF

    Found USDMF

    12078
    Active
    FENOFIBRATE
    1996-08-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-314 - Rev 02
    Valid
    Fenofibrate
    2018-01-29
    Japanese DMF

    Found JDMF

    222MF10028
    fenofibrate at 47, rue de Longvic B...
    2010-01-26
    Written Confirmation

    Close WC

    Application Number
    12078
    R1-CEP 2001-314 - Rev 02
    222MF10028
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    FENOFIBRATE
    Fenofibrate
    fenofibrate at 47, rue de Longvic B...
    Issue/Submission Date
    1996-08-05
    2018-01-29
    2010-01-26
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    • FDA
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    Metronidazole

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    USDMF

    Found USDMF

    3609
    Active
    METRONIDAZOLE USP
    1979-09-03
    CEP/COS

    Found CEP/COS

    R2-CEP 1995-052 - Rev 02
    Valid
    Metronidazole
    2018-04-25
    Japanese DMF

    Found JDMF

    220MF10104
    METRONIDAZOLE at Via Bergamo, 121, ...
    2008-04-11
    Written Confirmation

    Close WC

    Application Number
    3609
    R2-CEP 1995-052 - Rev 02
    220MF10104
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    METRONIDAZOLE USP
    Metronidazole
    METRONIDAZOLE at Via Bergamo, 121, ...
    Issue/Submission Date
    1979-09-03
    2018-04-25
    2008-04-11
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    • FDA
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    Bisoprolol Fumarate

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    USDMF

    Found USDMF

    13910
    Active
    BISOPROLOL FUMARATE
    1998-12-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2008-143 - Rev 01
    Valid
    Bisoprolol fumarate
    2018-01-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13910
    R1-CEP 2008-143 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BISOPROLOL FUMARATE
    Bisoprolol fumarate
    Issue/Submission Date
    1998-12-22
    2018-01-29
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    • FDA
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    Cetrorelix Acetate

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    USDMF

    Found USDMF

    18077
    Active
    CETRORELIX ACETATE BULK DRUG SUBSTA...
    2005-02-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10121
    Cetrorelix acetate at 310, Rue de R...
    2012-07-04
    Written Confirmation

    Close WC

    Application Number
    18077
    224MF10121
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CETRORELIX ACETATE BULK DRUG SUBSTA...
    Cetrorelix acetate at 310, Rue de R...
    Issue/Submission Date
    2005-02-11
    2012-07-04
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    • FDA
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    Linaclotide

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    USDMF

    Found USDMF

    24992
    Active
    LINACLOTIDE
    2011-05-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10090
    Linaclotide at 2075 North 55th Stre...
    2019-04-16
    Written Confirmation

    Close WC

    Application Number
    24992
    231MF10090
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LINACLOTIDE
    Linaclotide at 2075 North 55th Stre...
    Issue/Submission Date
    2011-05-27
    2019-04-16
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    • FDA
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    Mesalazine

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    USDMF

    Found USDMF

    11807
    Active
    MESALAMINE
    1996-01-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-243 - Rev 03
    Valid
    Mesalazine
    2018-03-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11807
    R1-CEP 2003-243 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    MESALAMINE
    Mesalazine
    Issue/Submission Date
    1996-01-15
    2018-03-29
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    • FDA
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    Oxybutynin Hydrochloride

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    USDMF

    Found USDMF

    12309
    Active
    OXYBUTYNIN HYDROCHLORIDE
    1997-01-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-200 - Rev 03
    Valid
    Oxybutynin hydrochloride
    2018-01-29
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12309
    R1-CEP 2001-200 - Rev 03
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    OXYBUTYNIN HYDROCHLORIDE
    Oxybutynin hydrochloride
    Issue/Submission Date
    1997-01-09
    2018-01-29
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    • FDA
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    Tetrabenazine

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    USDMF

    Found USDMF

    16683
    Active
    TETRABENAZINE
    2003-07-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10075
    Tetrabenazine at 47, rue de Longvic...
    2012-04-08
    Written Confirmation

    Close WC

    Application Number
    16683
    224MF10075
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    TETRABENAZINE
    Tetrabenazine at 47, rue de Longvic...
    Issue/Submission Date
    2003-07-03
    2012-04-08
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    • FDA
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    Naproxen

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    USDMF

    Caution USDMF

    11828
    Inactive
    NAPROXEN USP
    1996-01-26
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-081 - Rev 07
    Valid
    Naproxen
    2018-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11828
    R1-CEP 1996-081 - Rev 07
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    NAPROXEN USP
    Naproxen
    Issue/Submission Date
    1996-01-26
    2018-05-17
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    • FDA
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    1-Palmitoyl-2-Oleoyl-Sn-Glycero-3-Phosphocholine

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    USDMF

    Found USDMF

    14694
    Active
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    2000-02-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14694
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    Issue/Submission Date
    2000-02-15
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    • FDA
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    Afamelanotide

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    USDMF

    Found USDMF

    17471
    Active
    AFAMELANOTIDE BULK DRUG SUBSTANCE
    2004-06-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17471
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AFAMELANOTIDE BULK DRUG SUBSTANCE
    Issue/Submission Date
    2004-06-17
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    • FDA
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    Ampicillin Trihydrate

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    USDMF

    Found USDMF

    13728
    Active
    AMPICILLIN TRIHYDRATE STERILE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13728
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    AMPICILLIN TRIHYDRATE STERILE
    Issue/Submission Date
    1998-09-01
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    • FDA
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    Aztreonam

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10225
    Aztreonam at VIA MURILLO, 7, 04013-...
    2007-07-06
    Written Confirmation

    Close WC

    Application Number
    219MF10225
    Status
     
    Filing Details
    Aztreonam at VIA MURILLO, 7, 04013-...
    Issue/Submission Date
    2007-07-06
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    • FDA
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    Benzoyl Peroxide

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    USDMF

    Found USDMF

    14834
    Active
    BENZOYL PEROXIDE, HYDROUS
    2000-04-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14834
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BENZOYL PEROXIDE, HYDROUS
    Issue/Submission Date
    2000-04-12
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    • FDA
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    Bufexamac

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10882
    Bufexamac at Industrypark Roosveld ...
    2006-11-10
    Written Confirmation

    Close WC

    Application Number
    218MF10882
    Status
     
    Filing Details
    Bufexamac at Industrypark Roosveld ...
    Issue/Submission Date
    2006-11-10
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    • FDA
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    Buserelin Acetate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10206
    Buserelin acetate \"Mitsuba\" at 20...
    2007-06-13
    Written Confirmation

    Close WC

    Application Number
    219MF10206
    Status
     
    Filing Details
    Buserelin acetate \"Mitsuba\" at 20...
    Issue/Submission Date
    2007-06-13
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    • FDA
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    Carbadox

    PDF Supplier PDF
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    USDMF

    Found USDMF

    5884
    Active
    CARBADOX
    1985-06-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5884
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CARBADOX
    Issue/Submission Date
    1985-06-07
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    • FDA
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    Carbamazepine

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    9967
    Inactive
    CARBAMAZEPINE
    1992-11-19
    CEP/COS

    Caution CEP/COS

    R1-CEP 1997-119 - Rev 02
    Withdrawn by Holder
    Carbamazepine
    2008-02-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    9967
    R1-CEP 1997-119 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CARBAMAZEPINE
    Carbamazepine
    Issue/Submission Date
    1992-11-19
    2008-02-22
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    • FDA
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    Cefepime Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10166
    Cefepime hydrochloride hydrate at ...
    2016-08-19
    Written Confirmation

    Close WC

    Application Number
    228MF10166
    Status
     
    Filing Details
    Cefepime hydrochloride hydrate at ...
    Issue/Submission Date
    2016-08-19
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    • FDA
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    Choline Fenofibrate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    20950
    Active
    CHOLINE FENOFIBRATE DRUG SUBSTANCE
    2007-10-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20950
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CHOLINE FENOFIBRATE DRUG SUBSTANCE
    Issue/Submission Date
    2007-10-15
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    • FDA
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    Cimetidine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    5497
    Active
    CIMETIDINE
    1984-07-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    5497
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    CIMETIDINE
    Issue/Submission Date
    1984-07-30
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    Clotrimazole

    PDF Supplier PDF
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    USDMF

    Found USDMF

    10713
    Active
    CLOTRIMAZOLE
    1994-02-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10713
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CLOTRIMAZOLE
    Issue/Submission Date
    1994-02-04
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    Diclofenac Potassium

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    12217
    Inactive
    DICLOFENAC POTASSIUM
    1996-11-14
    CEP/COS

    Caution CEP/COS

    R0-CEP 2002-085 - Rev 01
    Withdrawn by Holder
    Diclofenac potassium
    2004-11-02
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12217
    R0-CEP 2002-085 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    DICLOFENAC POTASSIUM
    Diclofenac potassium
    Issue/Submission Date
    1996-11-14
    2004-11-02
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    • FDA
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    Doxylamine Succinate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    4741
    Active
    DOXYLAMINE SUCCINATE
    1982-11-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    4741
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DOXYLAMINE SUCCINATE
    Issue/Submission Date
    1982-11-15
    ASK
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    DPPC

    PDF Supplier PDF
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    USDMF

    Found USDMF

    12555
    Active
    1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPH...
    1997-06-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    12555
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    1,2-DIPALMITOYL-SN-GLYCERO-3-PHOSPH...
    Issue/Submission Date
    1997-06-23
    ASK
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    DSPC

    PDF Supplier PDF
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    USDMF

    Found USDMF

    14970
    Active
    1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHO...
    2000-07-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14970
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    1,2-DISTEAROYL-SN-GLYCERO-3-PHOSPHO...
    Issue/Submission Date
    2000-07-31
    ASK
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    • FDA
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    Fenofibrate

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

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    USDMF

    Found USDMF

    20725
    Active
    FENOFIBRATE INTERMEDIATE DRUG SUBST...
    2007-07-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20725
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FENOFIBRATE INTERMEDIATE DRUG SUBST...
    Issue/Submission Date
    2007-07-24
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    Glatiramer Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27723
    Active
    GLATIRAMER ACETATE
    2013-12-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27723
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    GLATIRAMER ACETATE
    Issue/Submission Date
    2013-12-12
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    Glucagon

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10886
    Glucagon -MT at 20910, Higgins Cour...
    2006-11-10
    Written Confirmation

    Close WC

    Application Number
    218MF10886
    Status
     
    Filing Details
    Glucagon -MT at 20910, Higgins Cour...
    Issue/Submission Date
    2006-11-10
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    • FDA
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    L-Arginine

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    28191
    Active
    CEFEPIME/L-ARGININE STERILE BLEND
    2014-05-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28191
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CEFEPIME/L-ARGININE STERILE BLEND
    Issue/Submission Date
    2014-05-15
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    • FDA
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    Larazotide Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    18561
    Active
    LARAZOTIDE
    2005-08-05
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    18561
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LARAZOTIDE
    Issue/Submission Date
    2005-08-05
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    Lutetium Chloride Lu-177

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    38043
    Active
    LUTETIUM (177LU) CHLORIDE SOLUTION ...
    2023-02-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38043
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LUTETIUM (177LU) CHLORIDE SOLUTION ...
    Issue/Submission Date
    2023-02-27
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    • FDA
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    Mesalazine

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Caution USDMF

    19993
    Inactive
    MESALAMINE HIGH DENSITY
    2006-11-20
    CEP/COS

    Caution CEP/COS

    R1-CEP 2006-300 - Rev 03
    Withdrawn by Holder
    Mesalazine, High density
    2019-12-16
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    19993
    R1-CEP 2006-300 - Rev 03
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    MESALAMINE HIGH DENSITY
    Mesalazine, High density
    Issue/Submission Date
    2006-11-20
    2019-12-16
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    Metaxalone

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    15087
    Active
    METAXALONE
    2000-10-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15087
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    METAXALONE
    Issue/Submission Date
    2000-10-11
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    Metronidazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 1996-067 - Rev 04
    Valid
    Metronidazole benzoate
    2018-05-31
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 1996-067 - Rev 04
    Status
    Valid
     
    Filing Details
    Metronidazole benzoate
    Issue/Submission Date
    2018-05-31
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    Nafarelin Acetate

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10511
    Nafarelin acetate \"Mitsuba\" at 20...
    2006-05-18
    Written Confirmation

    Close WC

    Application Number
    218MF10511
    Status
     
    Filing Details
    Nafarelin acetate \"Mitsuba\" at 20...
    Issue/Submission Date
    2006-05-18
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    Nafcillin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Found USDMF

    13653
    Active
    NAFCILLIN SODIUM STERILE
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13653
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    NAFCILLIN SODIUM STERILE
    Issue/Submission Date
    1998-09-01
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    Nebivolol

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

    See Less

    USDMF

    Found USDMF

    30052
    Active
    NEBIVOLOL HYDROCHLORIDE
    2015-12-03
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30052
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    NEBIVOLOL HYDROCHLORIDE
    Issue/Submission Date
    2015-12-03
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    Oxacillin Sodium

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    13433
    Active
    OXACILLIN SODIUM
    1998-09-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    13433
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    OXACILLIN SODIUM
    Issue/Submission Date
    1998-09-01
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    Oxytocin

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

    See Less

    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10157
    Oxytocin at 20901 Higgins Court Tor...
    2010-05-24
    Written Confirmation

    Close WC

    Application Number
    222MF10157
    Status
     
    Filing Details
    Oxytocin at 20901 Higgins Court Tor...
    Issue/Submission Date
    2010-05-24
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    Paclitaxel

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2009-126 - Rev 01
    Valid
    Paclitaxel, Produced by a semi-synt...
    2021-02-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2009-126 - Rev 01
    Status
    Valid
     
    Filing Details
    Paclitaxel, Produced by a semi-synt...
    Issue/Submission Date
    2021-02-05
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    POPG

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    14429
    Active
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    1999-09-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    14429
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-P...
    Issue/Submission Date
    1999-09-28
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    • FDA
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    Ranitidine Hydrochloride

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

    See Less

    USDMF

    Caution USDMF

    15676
    Inactive
    RANITIDINE HYDROCHLORIDE
    2001-10-19
    CEP/COS

    Caution CEP/COS

    R1-CEP 2005-301 - Rev 00
    Withdrawn by Holder
    Ranitidine hydrochloride
    2011-12-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15676
    R1-CEP 2005-301 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    RANITIDINE HYDROCHLORIDE
    Ranitidine hydrochloride
    Issue/Submission Date
    2001-10-19
    2011-12-09
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    Secnidazole

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    27383
    Active
    SECNIDAZOLE
    2013-08-01
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27383
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SECNIDAZOLE
    Issue/Submission Date
    2013-08-01
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    Sulfasalazine

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

    See Less

    USDMF

    Caution USDMF

    11163
    Inactive
    SULFASALAZINE
    1994-10-26
    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-278 - Rev 02
    Withdrawn by Holder
    Sulfasalazine
    2017-12-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11163
    R1-CEP 2004-278 - Rev 02
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    SULFASALAZINE
    Sulfasalazine
    Issue/Submission Date
    1994-10-26
    2017-12-20
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    Sulfiram

    PDF Supplier PDF
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    USDMF

    Found USDMF

    15041
    Active
    DISULFIRAM
    2000-09-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    15041
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DISULFIRAM
    Issue/Submission Date
    2000-09-15
    ASK
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    Tribenoside

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10037
    Japan Pharmaceutical Codex tribenos...
    2013-02-20
    Written Confirmation

    Close WC

    Application Number
    225MF10037
    Status
     
    Filing Details
    Japan Pharmaceutical Codex tribenos...
    Issue/Submission Date
    2013-02-20
    ASK
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    • FDA
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    Valganciclovir Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    30023
    Active
    VALGANCICLOVIR HYDROCHLORIDE
    2015-11-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30023
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    VALGANCICLOVIR HYDROCHLORIDE
    Issue/Submission Date
    2015-11-12
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    [3-[2,3-Dihydroxypropoxy(hydroxy)phosphoryl]oxy-2-tetra...

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    31533
    Active
    1,2 -DIMYRISTOYL-SN-GLYCERO-3-PHOSP...
    2017-03-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31533
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    1,2 -DIMYRISTOYL-SN-GLYCERO-3-PHOSP...
    Issue/Submission Date
    2017-03-21
    ASK
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    L-Arginine

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

    See Less

    USDMF

    Caution USDMF

    10131
    Inactive
    L-ARGININE
    1989-04-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10131
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    L-ARGININE
    Issue/Submission Date
    1989-04-07
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