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    Intas Pharmaceuticals
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    Country
    India
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    Address
    Chinubhai Centre, Off. Nehru Bridge, Ashram Road, Ahmedabad, Gujarat
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    +91 79 6652 3100
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    Pregabalin

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    USDMF

    Found USDMF

    27839
    Active
    PREGABALIN
    2014-01-06
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-028 - Rev 00
    Valid
    Pregabalin, Process II
    2023-07-04
    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0440
    Valid
    Pregabalin IH
    2022-02-02
    Application Number
    27839
    R0-CEP 2022-028 - Rev 00
    Indian CDSCO WC-0440
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Valid
    2025-03-04
    Filing Details
    PREGABALIN
    Pregabalin, Process II
    Pregabalin IH
    Issue/Submission Date
    2014-01-06
    2023-07-04
    2022-02-02
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    Doxorubicin Hydrochloride

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    USDMF

    Found USDMF

    34545
    Active
    DOXORUBICIN HYDROCHLORIDE USP
    2020-01-27
    CEP/COS

    Found CEP/COS

    CEP 2012-367 - Rev 02
    Valid
    Doxorubicin Hydrochloride
    2024-03-20
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0357
    Expired
    Doxorubicin Hydrochloride BP/EP
    2020-06-23
    Application Number
    34545
    CEP 2012-367 - Rev 02
    Indian CDSCO WC-0357
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2023-10-05
    Filing Details
    DOXORUBICIN HYDROCHLORIDE USP
    Doxorubicin Hydrochloride
    Doxorubicin Hydrochloride BP/EP
    Issue/Submission Date
    2020-01-27
    2024-03-20
    2020-06-23
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    Rivaroxaban

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    USDMF

    Found USDMF

    30562
    Active
    RIVAROXABAN FORM- I (MICRONIZED)
    2016-06-08
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-178 - Rev 00
    Valid
    Rivaroxaban, Micronised
    2022-09-06
    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0440A2
    Expired
    Rivaroxaban IH
    2022-01-05
    Application Number
    30562
    R0-CEP 2020-178 - Rev 00
    Indian CDSCO WC-0440A2
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Expired
    2022-03-04
    Filing Details
    RIVAROXABAN FORM- I (MICRONIZED)
    Rivaroxaban, Micronised
    Rivaroxaban IH
    Issue/Submission Date
    2016-06-08
    2022-09-06
    2022-01-05
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    Azacitidine

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    USDMF

    Found USDMF

    27821
    Active
    AZACITIDINE
    2013-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0440
    Valid
    Azacitidine IH
    2022-02-02
    Application Number
    27821
    Indian CDSCO WC-0440
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-03-04
    Filing Details
    AZACITIDINE
    Azacitidine IH
    Issue/Submission Date
    2013-12-30
    2022-02-02
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    • FDA
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    Capecitabine

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    USDMF

    Found USDMF

    24370
    Active
    CAPECITABINE USP
    2010-11-09
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-325 - Rev 01
    Valid
    Capecitabine
    2022-06-24
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24370
    R1-CEP 2015-325 - Rev 01
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CAPECITABINE USP
    Capecitabine
    Issue/Submission Date
    2010-11-09
    2022-06-24
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    Capecitabine

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    USDMF

    Found USDMF

    33574
    Active
    CAPECITABINE USP (PROCESS II)
    2019-03-04
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-143 - Rev 01
    Valid
    Capecitabine, Process II
    2022-06-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33574
    R0-CEP 2019-143 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CAPECITABINE USP (PROCESS II)
    Capecitabine, Process II
    Issue/Submission Date
    2019-03-04
    2022-06-27
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    Carmustine

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    USDMF

    Found USDMF

    33730
    Active
    CARMUSTINE USP
    2019-03-26
    CEP/COS

    Found CEP/COS

    R0-CEP 2019-272 - Rev 01
    Valid
    Carmustine
    2022-06-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33730
    R0-CEP 2019-272 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CARMUSTINE USP
    Carmustine
    Issue/Submission Date
    2019-03-26
    2022-06-27
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    Docetaxel

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    USDMF

    Found USDMF

    28756
    Active
    DOCETAXEL ANHYDROUS USP (PROCESS II...
    2014-10-29
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-155 - Rev 00
    Valid
    Docetaxel, Process-IIb
    2020-09-18
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28756
    R0-CEP 2020-155 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DOCETAXEL ANHYDROUS USP (PROCESS II...
    Docetaxel, Process-IIb
    Issue/Submission Date
    2014-10-29
    2020-09-18
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    Fingolimod Hydrochloride

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    USDMF

    Found USDMF

    28387
    Active
    FINGOLIMOD HYDROCHLORIDE (FORM 1)
    2014-06-24
    CEP/COS

    Found CEP/COS

    R0-CEP 2020-090 - Rev 01
    Valid
    Fingolimod hydrochloride
    2023-07-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28387
    R0-CEP 2020-090 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    FINGOLIMOD HYDROCHLORIDE (FORM 1)
    Fingolimod hydrochloride
    Issue/Submission Date
    2014-06-24
    2023-07-05
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    Gemcitabine

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    USDMF

    Found USDMF

    22748
    Active
    GEMCITABINE HYDROCHLORIDE USP
    2009-04-15
    CEP/COS

    Found CEP/COS

    R0-CEP 2022-092 - Rev 00
    Valid
    Gemcitabine hydrochloride, Process ...
    2022-07-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    22748
    R0-CEP 2022-092 - Rev 00
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP
    Gemcitabine hydrochloride, Process ...
    Issue/Submission Date
    2009-04-15
    2022-07-13
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    Gemcitabine

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    USDMF

    Found USDMF

    36573
    Active
    GEMCITABINE HYDROCHLORIDE USP (PROC...
    2021-12-24
    CEP/COS

    Found CEP/COS

    R1-CEP 2009-089 - Rev 02
    Valid
    Gemcitabine hydrochloride
    2022-07-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36573
    R1-CEP 2009-089 - Rev 02
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    GEMCITABINE HYDROCHLORIDE USP (PROC...
    Gemcitabine hydrochloride
    Issue/Submission Date
    2021-12-24
    2022-07-13
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    Imatinib Mesylate

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    USDMF

    Found USDMF

    32270
    Active
    IMATINIB MESYLATE (ß-FORM)
    2017-11-27
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-047 - Rev 01
    Valid
    Imatinib mesilate, β-form
    2022-06-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32270
    R0-CEP 2018-047 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    IMATINIB MESYLATE (ß-FORM)
    Imatinib mesilate, β-form
    Issue/Submission Date
    2017-11-27
    2022-06-27
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    Lacosamide

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    USDMF

    Found USDMF

    26520
    Active
    LACOSAMIDE
    2012-10-19
    CEP/COS

    Found CEP/COS

    R0-CEP 2018-247 - Rev 01
    Valid
    Lacosamide, Form I
    2022-06-27
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26520
    R0-CEP 2018-247 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    LACOSAMIDE
    Lacosamide, Form I
    Issue/Submission Date
    2012-10-19
    2022-06-27
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    Paclitaxel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    26792
    Active
    PACLITAXEL USP (SEMI-SYNTHETIC)
    2013-01-17
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-455 - Rev 00
    Valid
    Paclitaxel, Produced by a semi-synt...
    2022-04-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26792
    R0-CEP 2021-455 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PACLITAXEL USP (SEMI-SYNTHETIC)
    Paclitaxel, Produced by a semi-synt...
    Issue/Submission Date
    2013-01-17
    2022-04-08
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    Paclitaxel

    PDF Supplier PDF
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    USDMF

    Found USDMF

    36253
    Active
    PACLITAXEL (SEMI SYNTHETIC) USP (PR...
    2021-09-02
    CEP/COS

    Found CEP/COS

    R1-CEP 2012-385 - Rev 01
    Valid
    Paclitaxel, Produced by semi-synthe...
    2022-07-19
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36253
    R1-CEP 2012-385 - Rev 01
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PACLITAXEL (SEMI SYNTHETIC) USP (PR...
    Paclitaxel, Produced by semi-synthe...
    Issue/Submission Date
    2021-09-02
    2022-07-19
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    Pregabalin

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    USDMF

    Found USDMF

    36519
    Active
    PREGABALIN USP (PROCESS-II)
    2021-11-22
    CEP/COS

    Found CEP/COS

    R1-CEP 2017-149 - Rev 00
    Valid
    Pregabalin
    2023-07-07
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36519
    R1-CEP 2017-149 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    PREGABALIN USP (PROCESS-II)
    Pregabalin
    Issue/Submission Date
    2021-11-22
    2023-07-07
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    Teriflunomide

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    USDMF

    Found USDMF

    30491
    Active
    TERIFLUNOMIDE
    2016-04-21
    CEP/COS

    Found CEP/COS

    R0-CEP 2021-384 - Rev 00
    Valid
    Teriflunomide
    2022-12-08
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30491
    R0-CEP 2021-384 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    TERIFLUNOMIDE
    Teriflunomide
    Issue/Submission Date
    2016-04-21
    2022-12-08
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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    25495
    Inactive
    DOCETAXEL ANHYDROUS USP
    2011-11-03
    CEP/COS

    Found CEP/COS

    R1-CEP 2015-047 - Rev 01
    Valid
    Docetaxel, Process-II
    2022-07-13
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25495
    R1-CEP 2015-047 - Rev 01
    Status
    Inactive
    Fees Paid
    N/A
    Valid
     
    Filing Details
    DOCETAXEL ANHYDROUS USP
    Docetaxel, Process-II
    Issue/Submission Date
    2011-11-03
    2022-07-13
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    Bendamustine Hydrochloride

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    USDMF

    Found USDMF

    38685
    Active
    BENDAMUSTINE HYDROCHLORIDE
    2023-08-31
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    38685
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BENDAMUSTINE HYDROCHLORIDE
    Issue/Submission Date
    2023-08-31
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    Cabazitaxel

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    USDMF

    Found USDMF

    27978
    Active
    CABAZITAXEL (AMORPHOUS)
    2014-02-20
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27978
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CABAZITAXEL (AMORPHOUS)
    Issue/Submission Date
    2014-02-20
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    Carfilzomib

    PDF Supplier PDF
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    USDMF

    Found USDMF

    35083
    Active
    CARFILZOMIB
    2020-09-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35083
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CARFILZOMIB
    Issue/Submission Date
    2020-09-08
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    Dasatinib

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    USDMF

    Found USDMF

    35382
    Active
    DASATINIB
    2020-12-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35382
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DASATINIB
    Issue/Submission Date
    2020-12-02
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    Decitabine

    PDF Supplier PDF
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    USDMF

    Found USDMF

    25317
    Active
    DECITABINE
    2011-09-21
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    25317
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DECITABINE
    Issue/Submission Date
    2011-09-21
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    Dimethyl Fumarate

    PDF Supplier PDF
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    USDMF

    Found USDMF

    31204
    Active
    DIMETHYL FUMARATE
    2016-12-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    31204
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DIMETHYL FUMARATE
    Issue/Submission Date
    2016-12-09
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    Diroximel fumarate

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    USDMF

    Found USDMF

    34677
    Active
    DIROXIMEL FUMARATE
    2020-03-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34677
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DIROXIMEL FUMARATE
    Issue/Submission Date
    2020-03-27
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    Dofetilide

    PDF Supplier PDF
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    USDMF

    Found USDMF

    33305
    Active
    DOFETILIDE USP
    2018-11-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33305
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DOFETILIDE USP
    Issue/Submission Date
    2018-11-26
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    Erlotinib Hydrochloride

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    USDMF

    Found USDMF

    30885
    Active
    ERLOTINIB HYDROCHLORIDE
    2016-08-29
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30885
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ERLOTINIB HYDROCHLORIDE
    Issue/Submission Date
    2016-08-29
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    Fampridine

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    USDMF

    Found USDMF

    27819
    Active
    DALFAMPRIDINE
    2013-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27819
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    DALFAMPRIDINE
    Issue/Submission Date
    2013-12-30
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    Fesoterodine

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    USDMF

    Found USDMF

    26503
    Active
    FESOTERODINE FUMARATE
    2012-10-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    26503
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    FESOTERODINE FUMARATE
    Issue/Submission Date
    2012-10-13
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    Lurasidone Hydrochloride

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    USDMF

    Found USDMF

    28447
    Active
    LURASIDONE HYDROCHLORIDE
    2014-07-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28447
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LURASIDONE HYDROCHLORIDE
    Issue/Submission Date
    2014-07-09
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    Perampanel

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    USDMF

    Found USDMF

    30649
    Active
    PERAMPANEL
    2016-06-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30649
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PERAMPANEL
    Issue/Submission Date
    2016-06-24
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    Prasugrel Hydrochloride

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    USDMF

    Found USDMF

    27230
    Active
    PRASUGREL HYDROCHLORIDE
    2013-06-27
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27230
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PRASUGREL HYDROCHLORIDE
    Issue/Submission Date
    2013-06-27
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    Ribociclib

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    USDMF

    Found USDMF

    36335
    Active
    RIBOCICLIB SUCCINATE
    2021-09-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36335
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    RIBOCICLIB SUCCINATE
    Issue/Submission Date
    2021-09-30
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    Sodium Thiosulfate

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    USDMF

    Found USDMF

    36782
    Active
    SODIUM THIOSULFATE
    2022-02-15
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36782
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SODIUM THIOSULFATE
    Issue/Submission Date
    2022-02-15
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    Tipiracil Hydrochloride

    PDF Supplier PDF
    URL Supplier Web Content
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    USDMF

    Found USDMF

    33578
    Active
    TIPIRACIL HYDROCHLORIDE
    2019-02-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33578
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TIPIRACIL HYDROCHLORIDE
    Issue/Submission Date
    2019-02-19
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    Tofacitinib Citrate

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    USDMF

    Found USDMF

    37156
    Active
    TOFACITINIB CITRATE
    2022-06-22
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37156
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TOFACITINIB CITRATE
    Issue/Submission Date
    2022-06-22
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    Trazodone Hydrochloride

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    USDMF

    Found USDMF

    27820
    Active
    TRAZODONE HYDROCHLORIDE USP
    2013-12-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    27820
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TRAZODONE HYDROCHLORIDE USP
    Issue/Submission Date
    2013-12-30
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    Trifluridine

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    USDMF

    Found USDMF

    33615
    Active
    TRIFLURIDINE USP
    2019-03-08
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    33615
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    TRIFLURIDINE USP
    Issue/Submission Date
    2019-03-08
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    Vilazodone Hydrochloride

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    USDMF

    Found USDMF

    28702
    Active
    VILAZODONE HYDROCHLORIDE (AMORPHOUS...
    2014-10-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28702
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    VILAZODONE HYDROCHLORIDE (AMORPHOUS...
    Issue/Submission Date
    2014-10-10
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    Apremilast

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    USDMF

    Caution USDMF

    32179
    Inactive
    APREMILAST (AMORPHOUS)
    2017-10-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32179
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    APREMILAST (AMORPHOUS)
    Issue/Submission Date
    2017-10-23
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    Azacitidine

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    URL Supplier Web Content
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0440A1
    Expired
    Azacitidine IH
    2020-12-18
    Application Number
    Indian CDSCO WC-0440A1
    Status
     
    Expired
    2022-03-04
    Filing Details
    Azacitidine IH
    Issue/Submission Date
    2020-12-18
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    Dabigatran Etexilate Mesylate

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    28475
    Inactive
    DABIGATRAN ETEXILATE MESYLATE FORM-...
    2014-07-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    28475
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    DABIGATRAN ETEXILATE MESYLATE FORM-...
    Issue/Submission Date
    2014-07-25
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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    20608
    Inactive
    ANHYDROUS DOCETAXEL
    2007-06-11
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20608
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    ANHYDROUS DOCETAXEL
    Issue/Submission Date
    2007-06-11
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    Docetaxel

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    21930
    Inactive
    DOCETAXEL TRIHYDRATE API
    2008-10-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    21930
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    DOCETAXEL TRIHYDRATE API
    Issue/Submission Date
    2008-10-23
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    Docetaxel

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2012-301 - Rev 00
    Withdrawn by Holder
    Docetaxel
    2013-09-10
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R0-CEP 2012-301 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Docetaxel
    Issue/Submission Date
    2013-09-10
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    Epirubicin Hydrochloride

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Caution WC

    Indian CDSCO WC-0357
    Expired
    Epirubicin Hydrochloride BP/EP
    2020-06-23
    Application Number
    Indian CDSCO WC-0357
    Status
     
    Expired
    2023-10-05
    Filing Details
    Epirubicin Hydrochloride BP/EP
    Issue/Submission Date
    2020-06-23
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    Paclitaxel

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    17650
    Inactive
    PACLITAXEL API
    2004-09-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    17650
    Status
    Inactive
    Fees Unpaid
    N/A
     
    Filing Details
    PACLITAXEL API
    Issue/Submission Date
    2004-09-02
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    Pazopanib Hydrochloride

    PDF Supplier PDF
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    USDMF

    Caution USDMF

    34693
    Inactive
    PAZOPANIB HYDROCHLORIDE
    2020-03-23
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34693
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    PAZOPANIB HYDROCHLORIDE
    Issue/Submission Date
    2020-03-23
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    Sodium Methoxide Solution

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    Status
     
    Filing Details
    Issue/Submission Date
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