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    01 Adenine (1)

    02 Allopurinol (1)

    03 Articaine Hydrochloride (1)

    04 Atomoxetin Hydrochloride (1)

    05 Bisoprolol Fumarate (1)

    06 Brinzolamide (1)

    07 Buprenorphine Hydrochloride (1)

    08 CAS 116539-55-0 (1)

    09 CAS 38862-65-6 (1)

    10 Cannabidiol (1)

    11 Clindamycin Palmitate (1)

    12 Divalproex Sodium (2)

    13 Duloxetine (2)

    14 Hydroxychloroquine Sulphate (1)

    15 Loxoprofen Sodium (1)

    16 Menthadienol (1)

    17 Methylphenidate Hydrochloride (1)

    18 Olivetol (1)

    19 Pentobarbital Sodium (1)

    20 Pimobendan (1)

    21 Probucol (1)

    22 Propafenone Hydrochloride (1)

    23 Ritalinic Acid (2)

    24 Sodium Valproate (1)

    25 Thiopental Sodium (1)

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    01 Active (20)

    02 Inactive (1)

    03 Blank (7)

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    01 Valid (10)

    02 Blank (18)

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    01 220MF10111 (1)

    02 223MF10166 (1)

    03 224MF10096 (1)

    04 229MF10017 (1)

    05 229MF10022 (1)

    06 229MF10026 (1)

    07 229MF10059 (1)

    08 Blank (21)

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    01 Blank (28)

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    Divalproex Sodium

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    USDMF

    Found USDMF

    16558
    Active
    VALPROIC ACID
    2003-04-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-108 - Rev 05
    Valid
    Valproic acid
    2019-06-13
    Japanese DMF

    Found JDMF

    220MF10111
    Valproic acid at No. 61, Ln. 309, H...
    2008-04-21
    Written Confirmation

    Close WC

    Application Number
    16558
    R1-CEP 2003-108 - Rev 05
    220MF10111
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    VALPROIC ACID
    Valproic acid
    Valproic acid at No. 61, Ln. 309, H...
    Issue/Submission Date
    2003-04-28
    2019-06-13
    2008-04-21
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    Propafenone Hydrochloride

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    USDMF

    Found USDMF

    23537
    Active
    PROPAFENONE HYDROCHLORIDE
    2010-02-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2010-183 - Rev 01
    Valid
    Propafenone hydrochloride
    2019-04-09
    Japanese DMF

    Found JDMF

    224MF10096
    Propafenone Hydrochloride at No. 61...
    2012-05-08
    Written Confirmation

    Close WC

    Application Number
    23537
    R1-CEP 2010-183 - Rev 01
    224MF10096
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PROPAFENONE HYDROCHLORIDE
    Propafenone hydrochloride
    Propafenone Hydrochloride at No. 61...
    Issue/Submission Date
    2010-02-04
    2019-04-09
    2012-05-08
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    Sodium Valproate

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    USDMF

    Found USDMF

    33350
    Active
    SODIUM VALPROATE
    2019-09-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2004-302 - Rev 04
    Valid
    Sodium valproate
    2019-07-26
    Japanese DMF

    Found JDMF

    229MF10059
    Sodium valproate at No. 61, Ln. 309...
    2017-03-03
    Written Confirmation

    Close WC

    Application Number
    33350
    R1-CEP 2004-302 - Rev 04
    229MF10059
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    SODIUM VALPROATE
    Sodium valproate
    Sodium valproate at No. 61, Ln. 309...
    Issue/Submission Date
    2019-09-24
    2019-07-26
    2017-03-03
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    Duloxetine

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    USDMF

    Caution USDMF

    23440
    Inactive
    DULOXETINE HYDROCHLORIDE (FROM (S)-...
    2010-01-08
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-217 - Rev 01
    Valid
    Duloxetine hydrochloride
    2022-09-21
    Japanese DMF

    Found JDMF

    229MF10017
    Duloxetine Hydrochloride at No. 61,...
    2017-01-25
    Written Confirmation

    Close WC

    Application Number
    23440
    R1-CEP 2012-217 - Rev 01
    229MF10017
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DULOXETINE HYDROCHLORIDE (FROM (S)-...
    Duloxetine hydrochloride
    Duloxetine Hydrochloride at No. 61,...
    Issue/Submission Date
    2010-01-08
    2022-09-21
    2017-01-25
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    Allopurinol

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    USDMF

    Found USDMF

    24876
    Active
    ALLOPURINOL
    2011-04-15
    CEP/COS

    Found CEP/COS

    R1-CEP 2002-164 - Rev 00
    Valid
    Allopurinol
    2009-01-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24876
    R1-CEP 2002-164 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ALLOPURINOL
    Allopurinol
    Issue/Submission Date
    2011-04-15
    2009-01-13
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    Articaine Hydrochloride

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    USDMF

    Found USDMF

    11877
    Active
    ARTICAINE HYDROCHLORIDE DRUG SUBSTA...
    1996-03-04
    CEP/COS

    Found CEP/COS

    R1-CEP 2003-215 - Rev 07
    Valid
    Articaine hydrochloride
    2019-07-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    11877
    R1-CEP 2003-215 - Rev 07
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    ARTICAINE HYDROCHLORIDE DRUG SUBSTA...
    Articaine hydrochloride
    Issue/Submission Date
    1996-03-04
    2019-07-08
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    Atomoxetin Hydrochloride

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    USDMF

    Found USDMF

    32363
    Active
    ATOMOXETINE HYDROCHLORIDE
    2018-06-28
    CEP/COS

    Found CEP/COS

    CEP 2017-029 - Rev 03
    Valid
    Atomoxetine hydrochloride
    2023-10-11
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32363
    CEP 2017-029 - Rev 03
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    ATOMOXETINE HYDROCHLORIDE
    Atomoxetine hydrochloride
    Issue/Submission Date
    2018-06-28
    2023-10-11
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    Brinzolamide

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    USDMF

    Found USDMF

    29746
    Active
    BRINZOLAMIDE
    2015-09-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10026
    Brinzolamide at No. 61, Ln. 309, Ha...
    2017-01-31
    Written Confirmation

    Close WC

    Application Number
    29746
    229MF10026
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BRINZOLAMIDE
    Brinzolamide at No. 61, Ln. 309, Ha...
    Issue/Submission Date
    2015-09-04
    2017-01-31
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    Hydroxychloroquine Sulphate

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    USDMF

    Found USDMF

    8619
    Active
    HYDROXYCHLOROQUINE SULFATE
    1990-06-27
    CEP/COS

    Found CEP/COS

    CEP 2017-297 - Rev 02
    Valid
    Hydroxychloroquine sulfate
    2023-12-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    8619
    CEP 2017-297 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    HYDROXYCHLOROQUINE SULFATE
    Hydroxychloroquine sulfate
    Issue/Submission Date
    1990-06-27
    2023-12-06
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    Probucol

    PDF Supplier PDF
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    USDMF

    Found USDMF

    17355
    Active
    PROBUCOL
    2004-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    229MF10022
    Probucol at No. 61, Ln. 309, Haihu ...
    2017-01-31
    Written Confirmation

    Close WC

    Application Number
    17355
    229MF10022
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    PROBUCOL
    Probucol at No. 61, Ln. 309, Haihu ...
    Issue/Submission Date
    2004-04-26
    2017-01-31
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