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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by ZCL Chemicals Limited

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    ZCL Chemicals Limited
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    Country
    Country
    India
    Address
    Address
    Birla Aurora, 12A, Dr Annie Besant Rd, Worli, Mumbai, 400030
    Telephone
    Telephone
    +91 22 615 39999
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    Email
    enquiries@pharmacompass.com
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    https://www.zclchemicals.com/
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    • FDA
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    Rivaroxaban

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    USDMF

    Found USDMF

    32115
    Active
    RIVAROXABAN
    2017-10-02
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-274 - Rev 00
    Valid
    Rivaroxaban
    2021-12-09
    Japanese DMF

    Found JDMF

    304MF10154
    Rivaroxaban at 215 Atrium, “C” ...
    2022-12-07
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Rivaroxaban IH
    2019-06-17
    Application Number
    32115
    R0-CEP 2020-274 - Rev 00
    304MF10154
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    RIVAROXABAN
    Rivaroxaban
    Rivaroxaban at 215 Atrium, “C” ...
    Rivaroxaban IH
    Issue/Submission Date
    2017-10-02
    2021-12-09
    2022-12-07
    2019-06-17
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    Aripiprazole

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    USDMF

    Found USDMF

    30120
    Active
    ARIPIPRAZOLE USP
    2015-12-14
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-021 - Rev 01
    Valid
    Aripiprazole
    2023-01-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Aripiprazole EP/USP
    2019-06-17
    Application Number
    30120
    R1-CEP 2016-021 - Rev 01
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ARIPIPRAZOLE USP
    Aripiprazole
    Aripiprazole EP/USP
    Issue/Submission Date
    2015-12-14
    2023-01-12
    2019-06-17
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    • FDA
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    Atomoxetin Hydrochloride

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    USDMF

    Found USDMF

    29211
    Active
    ATOMOXETINE HYDROCHLORIDE USP
    2015-03-26
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-150 - Rev 00
    Valid
    Atomoxetine hydrochloride
    2022-07-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Atomoxetine Hydrochloride EP/USP
    2019-06-17
    Application Number
    29211
    R1-CEP 2015-150 - Rev 00
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    ATOMOXETINE HYDROCHLORIDE USP
    Atomoxetine hydrochloride
    Atomoxetine Hydrochloride EP/USP
    Issue/Submission Date
    2015-03-26
    2022-07-18
    2019-06-17
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    • FDA
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    Clozapine

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    USDMF

    Found USDMF

    31999
    Active
    CLOZAPINE USP
    2017-08-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-192 - Rev 01
    Valid
    Clozapine
    2021-02-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Clozapine BP/USP/EP
    2019-06-17
    Application Number
    31999
    R0-CEP 2018-192 - Rev 01
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    CLOZAPINE USP
    Clozapine
    Clozapine BP/USP/EP
    Issue/Submission Date
    2017-08-24
    2021-02-12
    2019-06-17
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    • FDA
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    Dapsone

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35342
    Active
    DAPSONE USP
    2020-10-30
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-358 - Rev 00
    Valid
    Dapsone
    2023-01-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195A4
    Expired
    Dapsone EP/USP
    2021-08-27
    Application Number
    35342
    R0-CEP 2020-358 - Rev 00
    Indian CDSCO WC-0195A4
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Expired
    2022-07-02
    Filing Details
    DAPSONE USP
    Dapsone
    Dapsone EP/USP
    Issue/Submission Date
    2020-10-30
    2023-01-17
    2021-08-27
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    • FDA
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    Fluvoxamine

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    USDMF

    Found USDMF

    29582
    Active
    FLUVOXAMINE MALEATE USP
    2015-07-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2014-089 - Rev 02
    Valid
    Fluvoxamine maleate
    2023-03-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Fluvoxamine Maleate EP/USP
    2019-06-17
    Application Number
    29582
    R1-CEP 2014-089 - Rev 02
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    FLUVOXAMINE MALEATE USP
    Fluvoxamine maleate
    Fluvoxamine Maleate EP/USP
    Issue/Submission Date
    2015-07-22
    2023-03-27
    2019-06-17
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    • FDA
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    Pirfenidone

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    USDMF

    Found USDMF

    32201
    Active
    PIRFENIDONE
    2017-10-28
    CEP/COS

    Found CEP/COS

    CEP 2017-259 - Rev 02
    Valid
    Pirfenidone
    2023-10-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Pirfenidone BP/EP
    2019-06-17
    Application Number
    32201
    CEP 2017-259 - Rev 02
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    PIRFENIDONE
    Pirfenidone
    Pirfenidone BP/EP
    Issue/Submission Date
    2017-10-28
    2023-10-04
    2019-06-17
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    • FDA
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    Quetiapine Hemifumarate

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    USDMF

    Found USDMF

    32085
    Active
    QUETIAPINE FUMARATE USP
    2017-10-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-175 - Rev 00
    Valid
    Quetiapine Fumarate
    2023-06-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Quetiapine Fumarate BP/EP/USP
    2019-06-17
    Application Number
    32085
    R1-CEP 2017-175 - Rev 00
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-07-02
    Filing Details
    QUETIAPINE FUMARATE USP
    Quetiapine Fumarate
    Quetiapine Fumarate BP/EP/USP
    Issue/Submission Date
    2017-10-03
    2023-06-20
    2019-06-17
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    Zonisamide

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    USDMF

    Found USDMF

    31298
    Active
    ZONISAMIDE USP
    2017-01-04
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10074
    Japanese Pharmacopoeia Zonisamide a...
    2019-03-19
    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Zonisamide USP
    2019-06-17
    Application Number
    31298
    231MF10074
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    ZONISAMIDE USP
    Japanese Pharmacopoeia Zonisamide a...
    Zonisamide USP
    Issue/Submission Date
    2017-01-04
    2019-03-19
    2019-06-17
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    • FDA
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    Apixaban

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34988
    Active
    APIXABAN
    2020-07-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195A4
    Expired
    Apixaban IH
    2021-08-27
    Application Number
    34988
    Indian CDSCO WC-0195A4
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    APIXABAN
    Apixaban IH
    Issue/Submission Date
    2020-07-02
    2021-08-27
    ASK
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    • FDA
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    Betahistine Dihydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2013-240 - Rev 01
    Valid
    Betahistine dihydrochloride
    2021-02-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Betahistine Hydrochloride USP/EP/BP
    2019-06-17
    Application Number
    R1-CEP 2013-240 - Rev 01
    Indian CDSCO WC-0195
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Betahistine dihydrochloride
    Betahistine Hydrochloride USP/EP/BP
    Issue/Submission Date
    2021-02-12
    2019-06-17
    ASK
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    • FDA
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    Dapagliflozin Propanediol Monohydrate

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    34235
    Active
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    2019-10-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195A4
    Expired
    Dapagliflozin Propanediol Monohydra...
    2021-08-27
    Application Number
    34235
    Indian CDSCO WC-0195A4
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    DAPAGLIFLOZIN PROPANEDIOL MONOHYDRA...
    Dapagliflozin Propanediol Monohydra...
    Issue/Submission Date
    2019-10-15
    2021-08-27
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    • FDA
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    Eslicarbazepine Acetate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33028
    Active
    ESLICARBAZEPINE ACETATE
    2018-08-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Eslicarbazepine Acetate IH
    2019-06-17
    Application Number
    33028
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    ESLICARBAZEPINE ACETATE
    Eslicarbazepine Acetate IH
    Issue/Submission Date
    2018-08-09
    2019-06-17
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    • FDA
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    Levomepromazine Maleate

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2018-144 - Rev 03
    Valid
    Levomepromazine maleate
    2023-08-09
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Levomepromazine Maleate EP/BP
    2019-06-17
    Application Number
    R0-CEP 2018-144 - Rev 03
    Indian CDSCO WC-0195
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Levomepromazine maleate
    Levomepromazine Maleate EP/BP
    Issue/Submission Date
    2023-08-09
    2019-06-17
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    • FDA
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    Lurasidone Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31801
    Active
    LURASIDONE HYDROCHLORIDE
    2017-06-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Lurasidone Hydrochloride IH
    2019-06-17
    Application Number
    31801
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    LURASIDONE HYDROCHLORIDE
    Lurasidone Hydrochloride IH
    Issue/Submission Date
    2017-06-06
    2019-06-17
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    • FDA
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    Memantine Hydrochloride

    PDF Supplier PDF
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    USDMF

    Found USDMF

    29180
    Active
    MEMANTINE HYDROCHLORIDE USP
    2015-03-16
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Memantine Hydrochloride USP
    2019-06-17
    Application Number
    29180
    Indian CDSCO WC-0195
    Status
    Active
    Fees Paid
    Reviewed
     
    Expired
    2022-07-02
    Filing Details
    MEMANTINE HYDROCHLORIDE USP
    Memantine Hydrochloride USP
    Issue/Submission Date
    2015-03-16
    2019-06-17
    ASK
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    • FDA
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    Methylphenidate Hydrochloride

    PDF Supplier PDF
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R1-CEP 2017-181 - Rev 00
    Valid
    Methylphenidate hydrochloride
    2023-01-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Methylphenidate Hydrochloride EP/US...
    2019-06-17
    Application Number
    R1-CEP 2017-181 - Rev 00
    Indian CDSCO WC-0195
    Status
    Valid
     
    Expired
    2022-07-02
    Filing Details
    Methylphenidate hydrochloride
    Methylphenidate Hydrochloride EP/US...
    Issue/Submission Date
    2023-01-12
    2019-06-17
    ASK
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    Mirabegron

    PDF Supplier PDF
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    See Less

    USDMF

    Found USDMF

    33821
    Active
    MIRABEGRON
    2019-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195A4
    Expired
    Mirabegron IH
    2021-08-27
    Application Number
    33821
    Indian CDSCO WC-0195A4
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    MIRABEGRON
    Mirabegron IH
    Issue/Submission Date
    2019-04-26
    2021-08-27
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    Ticagrelor

    PDF Supplier PDF
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    USDMF

    Found USDMF

    34420
    Active
    TICAGRELOR
    2019-12-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195A4
    Expired
    Ticagrelor IH
    2021-08-27
    Application Number
    34420
    Indian CDSCO WC-0195A4
    Status
    Active
    Fees Paid
    N/A
     
    Expired
    2022-07-02
    Filing Details
    TICAGRELOR
    Ticagrelor IH
    Issue/Submission Date
    2019-12-31
    2021-08-27
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    • FDA
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    Atomoxetin Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    See Less

    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2019-212 - Rev 01
    Valid
    Atomoxetine hydrochloride, Process ...
    2021-02-12
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2019-212 - Rev 01
    Status
    Valid
     
    Filing Details
    Atomoxetine hydrochloride, Process ...
    Issue/Submission Date
    2021-02-12
    ASK
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    CAS 160707-37-9

    PDF Supplier PDF
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    USDMF

    Found USDMF

    27932
    Active
    THREO PHENYL-2- PIPERIDYL ACETAMIDE
    2014-01-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27932
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    THREO PHENYL-2- PIPERIDYL ACETAMIDE
    Issue/Submission Date
    2014-01-21
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    CAS 19982-07-1

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    USDMF

    Found USDMF

    33684
    Active
    1-ACETAMIDO 3,5-DIMETHYL ADAMANTANE
    2019-03-29
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    33684
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    1-ACETAMIDO 3,5-DIMETHYL ADAMANTANE
    Issue/Submission Date
    2019-03-29
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    Empagliflozin

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    USDMF

    Found USDMF

    36944
    Active
    EMPAGLIFLOZIN
    2022-07-12
    CEP/COS

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    Japanese DMF

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    Application Number
    36944
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    EMPAGLIFLOZIN
    Issue/Submission Date
    2022-07-12
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    Maraviroc

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    USDMF

    Found USDMF

    35789
    Active
    MARAVIROC
    2021-09-24
    CEP/COS

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    Japanese DMF

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    Application Number
    35789
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    MARAVIROC
    Issue/Submission Date
    2021-09-24
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    Ritalinic Acid

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    USDMF

    Found USDMF

    21038
    Active
    RITALINIC ACID
    2007-11-07
    CEP/COS

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    Application Number
    21038
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    RITALINIC ACID
    Issue/Submission Date
    2007-11-07
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    Ritalinic Acid

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    USDMF

    Found USDMF

    27931
    Active
    D-THREO RITALINIC ACID HYDROCHLORID...
    2014-01-21
    CEP/COS

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    Japanese DMF

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    Application Number
    27931
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    D-THREO RITALINIC ACID HYDROCHLORID...
    Issue/Submission Date
    2014-01-21
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    4-Biphenylacetic Acid

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    USDMF

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    CEP/COS

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    Japanese DMF

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    Written Confirmation

    Caution WC

    Indian CDSCO WC-0195
    Expired
    Felbinac BP/EP
    2019-06-17
    Application Number
    Indian CDSCO WC-0195
    Status
     
    Expired
    2022-07-02
    Filing Details
    Felbinac BP/EP
    Issue/Submission Date
    2019-06-17
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    Levomepromazine Maleate

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-263 - Rev 00
    Withdrawn by Holder
    Levomepromazine maleate
    2014-03-25
    Japanese DMF

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    Written Confirmation

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    Application Number
    R0-CEP 2012-263 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Levomepromazine maleate
    Issue/Submission Date
    2014-03-25
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    2-HYDROXYETHYL-N,N,N',N'-TETRAKIS(2-CHLOROETHYL) PHOSPH...

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    USDMF

    Caution USDMF

    20345
    Inactive
    2-HYDROXYETHYL-N,N,N',N'-TETRAKIS(2...
    2007-03-14
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    20345
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    2-HYDROXYETHYL-N,N,N',N'-TETRAKIS(2...
    Issue/Submission Date
    2007-03-14
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    Bempedoic Acid

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    USDMF

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    Cannabidiol

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    Dabigatran Etexilate Mesylate

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    USDMF

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    CEP/COS

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    Darunavir

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    USDMF

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    Japanese DMF

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    Filing Details
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    Darunavir Ethanolate

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    Dexmethylphenidate

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    Favipiravir

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    USDMF

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    Ivabradine Hydrochloride

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    USDMF

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    Laninamivir Octanoate

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    Miglustat

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    Modafinil

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    Olanzapine

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    Ranolazine

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    Remdesivir

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    Solifenacin Succinate

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