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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Sumitomo Chemical Company Limited

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    Sumitomo Chemical
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    Country
    Country
    Japan
    Address
    Address
    Tokyo Nihombashi Tower, 2-7-1, Nihonbashi, Chuo-ku, Tokyo 103-6020
    Telephone
    Telephone
    +81-3-5201-0200
    Client Email
    Email
    enquiries@pharmacompass.com
    Client Website
    Website
    https://www.sumitomo-chem.co.jp/english/
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    Hydralazine Hydrochloride

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    USDMF

    Found USDMF

    2421
    Active
    HYDRALAZINE HYDROCHLORIDE
    1975-03-14
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-170 - Rev 02
    Valid
    Hydralazine hydrochloride
    2022-03-21
    Japanese DMF

    Found JDMF

    219MF10233
    Japanese Pharmacopoeia hydralazine ...
    2007-07-06
    Written Confirmation

    Close WC

    Application Number
    2421
    R0-CEP 2018-170 - Rev 02
    219MF10233
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDRALAZINE HYDROCHLORIDE
    Hydralazine hydrochloride
    Japanese Pharmacopoeia hydralazine ...
    Issue/Submission Date
    1975-03-14
    2022-03-21
    2007-07-06
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    Disopyramide

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    USDMF

    Found USDMF

    4687
    Active
    DISOPYRAMIDE PHOSPHATE USP
    1982-10-14
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    226MF10133
    Disopyramide [CP] at 2-27-1 Shinkaw...
    2014-07-02
    Written Confirmation

    Close WC

    Application Number
    4687
    226MF10133
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DISOPYRAMIDE PHOSPHATE USP
    Disopyramide [CP] at 2-27-1 Shinkaw...
    Issue/Submission Date
    1982-10-14
    2014-07-02
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    Bicalutamide

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    USDMF

    Caution USDMF

    19311
    Inactive
    BICALUTAMIDE DRUG SUBSTANCE
    2006-03-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10219
    Bicalutamide at 2-7-1 Nihonbashi, C...
    2010-08-10
    Written Confirmation

    Close WC

    Application Number
    19311
    222MF10219
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    BICALUTAMIDE DRUG SUBSTANCE
    Bicalutamide at 2-7-1 Nihonbashi, C...
    Issue/Submission Date
    2006-03-31
    2010-08-10
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    • FDA
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    Mirtazapine

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    USDMF

    Caution USDMF

    15300
    Inactive
    MIRTAZAPINE
    2001-02-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10107
    Mirtazapine at 2-27-1 Shinkawa, Chu...
    2017-06-21
    Written Confirmation

    Close WC

    Application Number
    15300
    229MF10107
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    MIRTAZAPINE
    Mirtazapine at 2-27-1 Shinkawa, Chu...
    Issue/Submission Date
    2001-02-22
    2017-06-21
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    Oteracil Potassium

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    USDMF

    Caution USDMF

    13908
    Inactive
    POTASSIUM OTASTAT
    1998-12-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10375
    Oteracil potassium at 2-27-1 Shinka...
    2007-12-19
    Written Confirmation

    Close WC

    Application Number
    13908
    219MF10375
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    POTASSIUM OTASTAT
    Oteracil potassium at 2-27-1 Shinka...
    Issue/Submission Date
    1998-12-22
    2007-12-19
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    • FDA
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    Paroxetine Hydrochloride

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    USDMF

    Caution USDMF

    13888
    Inactive
    PAROXETINE HYDROCHLORIDE ANHYDRATE
    1998-12-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10199
    Paroxetine hydrochloride hydrate at...
    2010-07-14
    Written Confirmation

    Close WC

    Application Number
    13888
    222MF10199
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PAROXETINE HYDROCHLORIDE ANHYDRATE
    Paroxetine hydrochloride hydrate at...
    Issue/Submission Date
    1998-12-07
    2010-07-14
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    • FDA
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    Phenothrin

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    USDMF

    Caution USDMF

    5631
    Inactive
    SUMITHRIN
    1984-11-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10106
    Phenothrin at 2-7-1 Nihonbashi, Chu...
    2013-05-20
    Written Confirmation

    Close WC

    Application Number
    5631
    225MF10106
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SUMITHRIN
    Phenothrin at 2-7-1 Nihonbashi, Chu...
    Issue/Submission Date
    1984-11-30
    2013-05-20
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    • FDA
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    4-Biphenylacetic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10189
    Japanese Pharmacopoeia felbinac at ...
    2008-08-18
    Written Confirmation

    Close WC

    Application Number
    220MF10189
    Status
     
    Filing Details
    Japanese Pharmacopoeia felbinac at ...
    Issue/Submission Date
    2008-08-18
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    Bezafibrate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10226
    Japanese Pharmacopoeia bezafibrate ...
    2007-07-06
    Written Confirmation

    Close WC

    Application Number
    219MF10226
    Status
     
    Filing Details
    Japanese Pharmacopoeia bezafibrate ...
    Issue/Submission Date
    2007-07-06
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    Bezafibrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10051
    Japanese Pharmacopoeia bezafibrate ...
    2010-02-12
    Written Confirmation

    Close WC

    Application Number
    222MF10051
    Status
     
    Filing Details
    Japanese Pharmacopoeia bezafibrate ...
    Issue/Submission Date
    2010-02-12
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    Bezafibrate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10164
    Bezafibrate (OK) at 2-7-1 Nihonbash...
    2011-11-28
    Written Confirmation

    Close WC

    Application Number
    223MF10164
    Status
     
    Filing Details
    Bezafibrate (OK) at 2-7-1 Nihonbash...
    Issue/Submission Date
    2011-11-28
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    • FDA
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    Bovine Serum

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2014-069 - Rev 00
    Valid
    Bovine hydroxyapatite
    2019-10-22
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2014-069 - Rev 00
    Status
    Valid
     
    Filing Details
    Bovine hydroxyapatite
    Issue/Submission Date
    2019-10-22
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    Cinchocaine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10234
    Japanese Pharmacopoeia dibucaine hy...
    2007-07-06
    Written Confirmation

    Close WC

    Application Number
    219MF10234
    Status
     
    Filing Details
    Japanese Pharmacopoeia dibucaine hy...
    Issue/Submission Date
    2007-07-06
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    • FDA
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    Crotamiton

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10075
    Japan Pharmaceutical Codex crotamit...
    2005-05-23
    Written Confirmation

    Close WC

    Application Number
    217MF10075
    Status
     
    Filing Details
    Japan Pharmaceutical Codex crotamit...
    Issue/Submission Date
    2005-05-23
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    Disopyramide

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10085
    Japanese Pharmacopoeia disopyramide...
    2005-05-23
    Written Confirmation

    Close WC

    Application Number
    217MF10085
    Status
     
    Filing Details
    Japanese Pharmacopoeia disopyramide...
    Issue/Submission Date
    2005-05-23
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    Disopyramide

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10097
    Japan Pharmaceutical Codex disopyra...
    2005-05-23
    Written Confirmation

    Close WC

    Application Number
    217MF10097
    Status
     
    Filing Details
    Japan Pharmaceutical Codex disopyra...
    Issue/Submission Date
    2005-05-23
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    • FDA
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    Fexofenadine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10088
    Japanese Pharmacopoeia fexofenadine...
    2011-06-27
    Written Confirmation

    Close WC

    Application Number
    223MF10088
    Status
     
    Filing Details
    Japanese Pharmacopoeia fexofenadine...
    Issue/Submission Date
    2011-06-27
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    • FDA
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    Imatinib Mesylate

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10163
    Imatinib mesylate at 2-7-1 Nihonbas...
    2012-08-16
    Written Confirmation

    Close WC

    Application Number
    224MF10163
    Status
     
    Filing Details
    Imatinib mesylate at 2-7-1 Nihonbas...
    Issue/Submission Date
    2012-08-16
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    • FDA
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    Ipriflavone

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10198
    Japanese Pharmacopoeia ipriflavone ...
    2010-07-13
    Written Confirmation

    Close WC

    Application Number
    222MF10198
    Status
     
    Filing Details
    Japanese Pharmacopoeia ipriflavone ...
    Issue/Submission Date
    2010-07-13
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    Lanthanum Carbonate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10014
    Lanthanum carbonate hydrate at 2-27...
    2017-01-23
    Written Confirmation

    Close WC

    Application Number
    229MF10014
    Status
     
    Filing Details
    Lanthanum carbonate hydrate at 2-27...
    Issue/Submission Date
    2017-01-23
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    Lanthanum Carbonate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    301MF10027
    Lanthanum carbonate hydrate (SU) at...
    2019-07-05
    Written Confirmation

    Close WC

    Application Number
    301MF10027
    Status
     
    Filing Details
    Lanthanum carbonate hydrate (SU) at...
    Issue/Submission Date
    2019-07-05
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    Lidocaine

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10089
    Japanese Pharmacopoeia lidocaine at...
    2005-05-23
    Written Confirmation

    Close WC

    Application Number
    217MF10089
    Status
     
    Filing Details
    Japanese Pharmacopoeia lidocaine at...
    Issue/Submission Date
    2005-05-23
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    Mequitazine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10270
    Japanese Pharmacopoeia mequitazine ...
    2006-02-17
    Written Confirmation

    Close WC

    Application Number
    218MF10270
    Status
     
    Filing Details
    Japanese Pharmacopoeia mequitazine ...
    Issue/Submission Date
    2006-02-17
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    Metaqualone

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10077
    Japanese Pharmacopoeia afloqualone ...
    2005-05-23
    Written Confirmation

    Close WC

    Application Number
    217MF10077
    Status
     
    Filing Details
    Japanese Pharmacopoeia afloqualone ...
    Issue/Submission Date
    2005-05-23
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    Milnacipran Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10844
    Milnacipran hydrochloride at 2-27-1...
    2006-10-20
    Written Confirmation

    Close WC

    Application Number
    218MF10844
    Status
     
    Filing Details
    Milnacipran hydrochloride at 2-27-1...
    Issue/Submission Date
    2006-10-20
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    Olmesartan Medoxomil

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10290
    Japanese Pharmacopoeia olmesartan m...
    2015-12-24
    Written Confirmation

    Close WC

    Application Number
    227MF10290
    Status
     
    Filing Details
    Japanese Pharmacopoeia olmesartan m...
    Issue/Submission Date
    2015-12-24
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    Olopatadine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10280
    Olopatadine hydrochloride at 2-7-1 ...
    2010-12-24
    Written Confirmation

    Close WC

    Application Number
    222MF10280
    Status
     
    Filing Details
    Olopatadine hydrochloride at 2-7-1 ...
    Issue/Submission Date
    2010-12-24
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    Olopatadine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    225MF10202
    Olopatadine hydrochloride (K) at 2-...
    2013-11-11
    Written Confirmation

    Close WC

    Application Number
    225MF10202
    Status
     
    Filing Details
    Olopatadine hydrochloride (K) at 2-...
    Issue/Submission Date
    2013-11-11
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    Phenethicillin Potassium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10230
    Japanese Pharmacopoeia chlorine phe...
    2007-07-06
    Written Confirmation

    Close WC

    Application Number
    219MF10230
    Status
     
    Filing Details
    Japanese Pharmacopoeia chlorine phe...
    Issue/Submission Date
    2007-07-06
    ASK
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    Pregabalin

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    230MF10072
    Pregabalin at 2-7-1 Nihonbashi, Chu...
    2018-06-20
    Written Confirmation

    Close WC

    Application Number
    230MF10072
    Status
     
    Filing Details
    Pregabalin at 2-7-1 Nihonbashi, Chu...
    Issue/Submission Date
    2018-06-20
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    Probucol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    222MF10231
    Japanese Pharmacopoeia probucol at ...
    2010-09-24
    Written Confirmation

    Close WC

    Application Number
    222MF10231
    Status
     
    Filing Details
    Japanese Pharmacopoeia probucol at ...
    Issue/Submission Date
    2010-09-24
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    Propylthiouracil

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10086
    Japanese Pharmacopoeia propylthiour...
    2005-05-23
    Written Confirmation

    Close WC

    Application Number
    217MF10086
    Status
     
    Filing Details
    Japanese Pharmacopoeia propylthiour...
    Issue/Submission Date
    2005-05-23
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    Quetiapine Hemifumarate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    223MF10089
    Quetiapine fumarate at 2-27-1 Shink...
    2011-06-27
    Written Confirmation

    Close WC

    Application Number
    223MF10089
    Status
     
    Filing Details
    Quetiapine fumarate at 2-27-1 Shink...
    Issue/Submission Date
    2011-06-27
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    Rivaroxaban

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    304MF10101
    Rivaroxaban at 2-7-1 Nihonbashi, Ch...
    2022-07-13
    Written Confirmation

    Close WC

    Application Number
    304MF10101
    Status
     
    Filing Details
    Rivaroxaban at 2-7-1 Nihonbashi, Ch...
    Issue/Submission Date
    2022-07-13
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    Sodium Valproate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10074
    Japanese Pharmacopoeia sodium valpr...
    2005-05-23
    Written Confirmation

    Close WC

    Application Number
    217MF10074
    Status
     
    Filing Details
    Japanese Pharmacopoeia sodium valpr...
    Issue/Submission Date
    2005-05-23
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    Telmisartan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10296
    Japanese Pharmacopoeia telmisartan ...
    2015-12-24
    Written Confirmation

    Close WC

    Application Number
    227MF10296
    Status
     
    Filing Details
    Japanese Pharmacopoeia telmisartan ...
    Issue/Submission Date
    2015-12-24
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    Trientine Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    218MF10740
    Japanese Pharmacopoeia trientine hy...
    2006-09-06
    Written Confirmation

    Close WC

    Application Number
    218MF10740
    Status
     
    Filing Details
    Japanese Pharmacopoeia trientine hy...
    Issue/Submission Date
    2006-09-06
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    Trimebutine Maleate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10228
    Japanese Pharmacopoeia trimebutine ...
    2007-07-06
    Written Confirmation

    Close WC

    Application Number
    219MF10228
    Status
     
    Filing Details
    Japanese Pharmacopoeia trimebutine ...
    Issue/Submission Date
    2007-07-06
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    Tulobuterol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF10099
    Tulobuterol at 2-27-1 Shinkawa, Chu...
    2005-05-23
    Written Confirmation

    Close WC

    Application Number
    217MF10099
    Status
     
    Filing Details
    Tulobuterol at 2-27-1 Shinkawa, Chu...
    Issue/Submission Date
    2005-05-23
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    Tulobuterol

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    219MF10229
    Japanese Pharmacopoeia tulobuterol ...
    2007-07-06
    Written Confirmation

    Close WC

    Application Number
    219MF10229
    Status
     
    Filing Details
    Japanese Pharmacopoeia tulobuterol ...
    Issue/Submission Date
    2007-07-06
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    Valsartan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    224MF10238
    Japanese Pharmacopoeia valsartan at...
    2012-12-26
    Written Confirmation

    Close WC

    Application Number
    224MF10238
    Status
     
    Filing Details
    Japanese Pharmacopoeia valsartan at...
    Issue/Submission Date
    2012-12-26
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    Valsartan

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    228MF10108
    Valsartan (GF) at 2-27-1 Shinkawa, ...
    2016-06-06
    Written Confirmation

    Close WC

    Application Number
    228MF10108
    Status
     
    Filing Details
    Valsartan (GF) at 2-27-1 Shinkawa, ...
    Issue/Submission Date
    2016-06-06
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    Valsartan

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10289
    Valsartan (GO) at 2-27-1 Shinkawa, ...
    2015-12-24
    Written Confirmation

    Close WC

    Application Number
    227MF10289
    Status
     
    Filing Details
    Valsartan (GO) at 2-27-1 Shinkawa, ...
    Issue/Submission Date
    2015-12-24
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    BNC-1021

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    USDMF

    Found USDMF

    32230
    Active
    BNC-1021
    2018-02-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32230
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    BNC-1021
    Issue/Submission Date
    2018-02-26
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    CPGB-02

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10123
    CPGB-02 at 2-27-1 Shinkawa, Chuo-ku...
    2017-07-14
    Written Confirmation

    Close WC

    Application Number
    229MF10123
    Status
     
    Filing Details
    CPGB-02 at 2-27-1 Shinkawa, Chuo-ku...
    Issue/Submission Date
    2017-07-14
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    CPGB

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10130
    CPGB at 2-27-1 Shinkawa, Chuo-ku, T...
    2015-04-30
    Written Confirmation

    Close WC

    Application Number
    227MF10130
    Status
     
    Filing Details
    CPGB at 2-27-1 Shinkawa, Chuo-ku, T...
    Issue/Submission Date
    2015-04-30
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    CDUL

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    USDMF

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    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10128
    CDUL at 2-27-1 Shinkawa, Chuo-ku, T...
    2015-04-23
    Written Confirmation

    Close WC

    Application Number
    227MF10128
    Status
     
    Filing Details
    CDUL at 2-27-1 Shinkawa, Chuo-ku, T...
    Issue/Submission Date
    2015-04-23
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    CPGB

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    227MF10015
    CPGB at 2-27-1 Shinkawa, Chuo-ku, T...
    2015-01-05
    Written Confirmation

    Close WC

    Application Number
    227MF10015
    Status
     
    Filing Details
    CPGB at 2-27-1 Shinkawa, Chuo-ku, T...
    Issue/Submission Date
    2015-01-05
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    Oxaprozin

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    11748
    Inactive
    OXAPROZIN
    1995-11-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11748
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    OXAPROZIN
    Issue/Submission Date
    1995-11-20
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    Sb 210232

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    10910
    Inactive
    SB210272
    1994-05-17
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    10910
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    SB210272
    Issue/Submission Date
    1994-05-17
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