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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Apicore LLC

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    Apicore LLC
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    Country
    Country
    India
    Address
    Address
    A-wing, 901 - 903 Kanakia Wall Street Andheri - Kurla Road, Chakala Andheri East, Mumbai- 400093 Maharashtra
    Telephone
    Telephone
    +91 9975615538
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    Email
    enquiries@pharmacompass.com
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    http://apicore.com/
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    • FDA
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    Bortezomib

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    USDMF

    Found USDMF

    22922
    Active
    BORTEZOMIB
    2009-06-30
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    231MF10057
    Bortezomib at 49 Napoleon Ct. , Som...
    2019-02-25
    Written Confirmation

    Close WC

    Application Number
    22922
    231MF10057
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BORTEZOMIB
    Bortezomib at 49 Napoleon Ct. , Som...
    Issue/Submission Date
    2009-06-30
    2019-02-25
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    Busulfan

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    USDMF

    Found USDMF

    23924
    Active
    BUSULFAN USP
    2010-08-05
    CEP/COS

    Found CEP/COS

    R1-CEP 2016-270 - Rev 00
    Valid
    Busulfan
    2023-05-17
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23924
    R1-CEP 2016-270 - Rev 00
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    BUSULFAN USP
    Busulfan
    Issue/Submission Date
    2010-08-05
    2023-05-17
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    Trabectedin

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    USDMF

    Found USDMF

    35828
    Active
    TRABECTEDIN
    2021-04-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Trabectedin IH
    2022-07-15
    Application Number
    35828
    Indian CDSCO WC-0110
    Status
    Active
    Fees Paid
    Reviewed
     
    Valid
    2025-07-02
    Filing Details
    TRABECTEDIN
    Trabectedin IH
    Issue/Submission Date
    2021-04-19
    2022-07-15
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    Alcaftadine

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    USDMF

    Found USDMF

    32382
    Active
    ALCAFTADINE
    2018-01-07
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    32382
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    ALCAFTADINE
    Issue/Submission Date
    2018-01-07
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    Bexarotene

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    USDMF

    Found USDMF

    23631
    Active
    BEXAROTENE
    2010-04-26
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    23631
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    BEXAROTENE
    Issue/Submission Date
    2010-04-26
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    Bromfenac Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Bromfenac Sodium IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Bromfenac Sodium IH
    Issue/Submission Date
    2022-07-15
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    Cevimeline Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Cevimeline HCl IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Cevimeline HCl IH
    Issue/Submission Date
    2022-07-15
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    Clofarabine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Clofarabine IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Clofarabine IH
    Issue/Submission Date
    2022-07-15
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    Cyclophosphamide

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    USDMF

    Found USDMF

    36089
    Active
    CYCLOPHOSPHAMIDE USP (STERILE BULK)
    2021-07-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36089
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    CYCLOPHOSPHAMIDE USP (STERILE BULK)
    Issue/Submission Date
    2021-07-28
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    Dacarbazine

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Dacarbazine (USP/EP) 
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Dacarbazine (USP/EP) 
    Issue/Submission Date
    2022-07-15
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    Degarelix Acetate

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    USDMF

    Found USDMF

    37005
    Active
    DEGARELIX ACETATE MANNITOL PREMIX 2...
    2023-04-19
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37005
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEGARELIX ACETATE MANNITOL PREMIX 2...
    Issue/Submission Date
    2023-04-19
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    Degarelix Acetate

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    USDMF

    Found USDMF

    37113
    Active
    DEGARELIX ACETATE MANNITOL PREMIX 4...
    2023-04-25
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37113
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    DEGARELIX ACETATE MANNITOL PREMIX 4...
    Issue/Submission Date
    2023-04-25
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    Dimetindene

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Dimetindene Maleate EP
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Dimetindene Maleate EP
    Issue/Submission Date
    2022-07-15
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    Ferric Carboxymaltose

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    USDMF

    Found USDMF

    36795
    Active
    FERRIC CARBOXYMALTOSE
    2022-03-10
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36795
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FERRIC CARBOXYMALTOSE
    Issue/Submission Date
    2022-03-10
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    Ferumoxytol

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    USDMF

    Found USDMF

    39032
    Active
    FERUMOXYTOL
    2023-10-24
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    39032
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FERUMOXYTOL
    Issue/Submission Date
    2023-10-24
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    Flibanserin

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    USDMF

    Found USDMF

    35336
    Active
    FLIBANSERIN
    2020-11-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35336
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    FLIBANSERIN
    Issue/Submission Date
    2020-11-12
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    • FDA
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    Ganirelix

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    USDMF

    Found USDMF

    36902
    Active
    GANIRELIX ACETATE
    2022-04-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    36902
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    GANIRELIX ACETATE
    Issue/Submission Date
    2022-04-28
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    • FDA
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    Methyltyrosine

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    USDMF

    Found USDMF

    37364
    Active
    METYROSINE, USP
    2022-09-06
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37364
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    METYROSINE, USP
    Issue/Submission Date
    2022-09-06
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    Miglustat

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Miglustat IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Miglustat IH
    Issue/Submission Date
    2022-07-15
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    Nadolol

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Nadolol (USP)
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Nadolol (USP)
    Issue/Submission Date
    2022-07-15
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    Penicillamine

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    USDMF

    Found USDMF

    30993
    Active
    PENICILLAMINE, USP
    2016-10-18
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    30993
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PENICILLAMINE, USP
    Issue/Submission Date
    2016-10-18
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    Perphenazine

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    USDMF

    Found USDMF

    24646
    Active
    PERPHENAZINE USP
    2012-11-28
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    24646
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    PERPHENAZINE USP
    Issue/Submission Date
    2012-11-28
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    Phentolamine Mesylate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Phentolamine Mesylate USP
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Phentolamine Mesylate USP
    Issue/Submission Date
    2022-07-15
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    Plerixafor

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Plerixafor IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Plerixafor IH
    Issue/Submission Date
    2022-07-15
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    Ponatinib

    PDF Supplier PDF
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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Ponatinib Hydrochloride IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Ponatinib Hydrochloride IH
    Issue/Submission Date
    2022-07-15
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    Safinamide Mesylate

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    USDMF

    Found USDMF

    34399
    Active
    SAFINAMIDE MESYLATE
    2020-02-13
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    34399
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    SAFINAMIDE MESYLATE
    Issue/Submission Date
    2020-02-13
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    Selegiline Hydrochloride

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    USDMF

    Found USDMF

    37046
    Active
    SELEGILINE
    2022-05-02
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    37046
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SELEGILINE
    Issue/Submission Date
    2022-05-02
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    Selexipag

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    USDMF

    Found USDMF

    35163
    Active
    SELEXIPAG-MANNITOL PREMIX
    2020-09-09
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    35163
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    SELEXIPAG-MANNITOL PREMIX
    Issue/Submission Date
    2020-09-09
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    Sugammadex Sodium

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Sugammadex Sodium IH
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Sugammadex Sodium IH
    Issue/Submission Date
    2022-07-15
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    Sulfiram

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Found WC

    Indian CDSCO WC-0110
    Valid
    Disulfiram (EP/USP)
    2022-07-15
    Application Number
    Indian CDSCO WC-0110
    Status
     
    Valid
    2025-07-02
    Filing Details
    Disulfiram (EP/USP)
    Issue/Submission Date
    2022-07-15
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    MTB008

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    USDMF

    Found USDMF

    36079
    Active
    MTB008
    2021-07-31
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    Application Number
    36079
    Status
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    MTB008
    Issue/Submission Date
    2021-07-31
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    Bromfenac Sodium

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    Indian CDSCO WC-0110a
    Expired
    Bromfenac Sodium IH
    2019-10-04
    Application Number
    Indian CDSCO WC-0110a
    Status
     
    Expired
    2022-07-02
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    Bromfenac Sodium IH
    Issue/Submission Date
    2019-10-04
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    Indian CDSCO WC-0110a
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    Cevimeline Hydrochloride IH
    2019-10-04
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    Indian CDSCO WC-0110a
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    Expired
    2022-07-02
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    Cevimeline Hydrochloride IH
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    2019-10-04
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    Indian CDSCO WC-0110a
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    Clofarabine IH
    2019-10-04
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    Indian CDSCO WC-0110a
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    Expired
    2022-07-02
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    Clofarabine IH
    Issue/Submission Date
    2019-10-04
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    Indian CDSCO WC-0110A3
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    Dacarbazine EP
    2019-12-05
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    Indian CDSCO WC-0110A3
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    2022-07-02
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    2019-12-05
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    2019-10-04
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    Indian CDSCO WC-0110a
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    2022-07-02
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    Dimetindene Maleate EP
    2019-10-04
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    Indian CDSCO WC-0110a
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    2022-07-02
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    USDMF

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    20438
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    FELBAMATE
    2007-04-12
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    Application Number
    20438
    Status
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    Fees Paid
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    FELBAMATE
    Issue/Submission Date
    2007-04-12
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    Indian CDSCO WC-0110a
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    Miglustat IH
    2019-10-04
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    Indian CDSCO WC-0110a
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    Expired
    2022-07-02
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    Miglustat IH
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    2019-10-04
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    Nadolol USP
    2019-10-04
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    Indian CDSCO WC-0110a
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    2022-07-02
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    2019-10-04
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    Phentolamine Mesylate USP
    2019-10-04
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    Indian CDSCO WC-0110a
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    Expired
    2022-07-02
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    Phentolamine Mesylate USP
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    2019-10-04
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    Indian CDSCO WC-0110A5
    Expired
    Ponatinib HCl
    2021-04-15
    Application Number
    Indian CDSCO WC-0110A5
    Status
     
    Expired
    2022-07-02
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    Ponatinib HCl
    Issue/Submission Date
    2021-04-15
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    21234
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    Protriptyline Hydrochloride
    2008-01-15
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    Application Number
    21234
    Status
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    Fees Paid
    N/A
     
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    Protriptyline Hydrochloride
    Issue/Submission Date
    2008-01-15
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    Indian CDSCO WC-0110A4
    Expired
    Sugammadex Sodium IH
    2020-11-05
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    Indian CDSCO WC-0110A4
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    Expired
    2022-07-02
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    Sugammadex Sodium IH
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    2020-11-05
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    Disulfiram EP/UP
    2019-10-04
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    Indian CDSCO WC-0110a
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    2022-07-02
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    Disulfiram EP/UP
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    2019-10-04
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    Indian CDSCO WC-0110A6
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    Trabectedin IH
    2021-11-23
    Application Number
    Indian CDSCO WC-0110A6
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    2022-07-02
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    Trabectedin IH
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    2021-11-23
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    Enasidenib

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