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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Deva Holding As

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    01 Aclidinium Bromide (1)

    02 Amlodipine Besylate (1)

    03 Amlodipine Mesylate (1)

    04 Apremilast (1)

    05 Benidipine Hydrochloride (1)

    06 Benserazide Hydrochloride (1)

    07 Cefuroxime Axetil (1)

    08 Clavulanic Acid (3)

    09 Dasatinib (1)

    10 Eltrombopag (1)

    11 Enzalutamide (1)

    12 Fingolimod Hydrochloride (1)

    13 Ibandronate Sodium (1)

    14 Imatinib Mesylate (1)

    15 Indacaterol Maleate (1)

    16 Isoproterenol Hydrochloride (1)

    17 Lenalidomide (1)

    18 Nilotinib (1)

    19 Olaparib (1)

    20 Palbociclib (1)

    21 Pazopanib Hydrochloride (1)

    22 Pomalidomide (1)

    23 Selexipag (1)

    24 Sugammadex Sodium (1)

    25 Teriflunomide (1)

    26 Tiotropium Bromide (1)

    27 Vismodegib (1)

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    01 Active (3)

    02 Inactive (1)

    03 Blank (25)

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    01 Expired (1)

    02 Valid (3)

    03 Withdrawn by Holder (3)

    04 Blank (22)

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    01 Blank (29)

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    01 Blank (29)

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    Benserazide Hydrochloride

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    USDMF

    Close USDMF

    CEP/COS

    Found CEP/COS

    R0-CEP 2021-345 - Rev 00
    Valid
    Benserazide hydrochloride
    2023-08-25
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2021-345 - Rev 00
    Status
    Valid
     
    Filing Details
    Benserazide hydrochloride
    Issue/Submission Date
    2023-08-25
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    Clavulanic Acid

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    USDMF

    Caution USDMF

    14065
    Inactive
    CLAVULANATE POTASSIUM
    1999-04-07
    CEP/COS

    Caution CEP/COS

    R1-CEP 2012-391 - Rev 00
    Withdrawn by Holder
    Potassium clavulanate, diluted, wit...
    2018-11-05
    Japanese DMF

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    Written Confirmation

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    Application Number
    14065
    R1-CEP 2012-391 - Rev 00
    Status
    Inactive
    Fees Paid
    N/A
    Withdrawn by Holder
     
    Filing Details
    CLAVULANATE POTASSIUM
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    1999-04-07
    2018-11-05
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    Fingolimod Hydrochloride

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    USDMF

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    CEP/COS

    Found CEP/COS

    R0-CEP 2020-352 - Rev 00
    Valid
    Fingolimod hydrochloride
    2022-05-03
    Japanese DMF

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    Written Confirmation

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    Application Number
    R0-CEP 2020-352 - Rev 00
    Status
    Valid
     
    Filing Details
    Fingolimod hydrochloride
    Issue/Submission Date
    2022-05-03
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    Imatinib Mesylate

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    USDMF

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    CEP/COS

    Found CEP/COS

    CEP 2016-299 - Rev 01
    Valid
    Imatinib mesilate, α Form
    2023-10-16
    Japanese DMF

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    Written Confirmation

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    Application Number
    CEP 2016-299 - Rev 01
    Status
    Valid
     
    Filing Details
    Imatinib mesilate, α Form
    Issue/Submission Date
    2023-10-16
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    Isoproterenol Hydrochloride

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    USDMF

    Found USDMF

    36634
    Active
    ISOPROTERENOL HYDROCHLORIDE USP
    2022-05-12
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    36634
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    ISOPROTERENOL HYDROCHLORIDE USP
    Issue/Submission Date
    2022-05-12
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    Lenalidomide

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    USDMF

    Found USDMF

    36440
    Active
    LENALIDOMIDE
    2021-12-09
    CEP/COS

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    Japanese DMF

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    Application Number
    36440
    Status
    Active
    Fees Paid
    Reviewed
     
    Filing Details
    LENALIDOMIDE
    Issue/Submission Date
    2021-12-09
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    Pomalidomide

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    USDMF

    Found USDMF

    39088
    Active
    POMALIDOMIDE
    2024-03-05
    CEP/COS

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    Japanese DMF

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    Application Number
    39088
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    POMALIDOMIDE
    Issue/Submission Date
    2024-03-05
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    Cefuroxime Axetil

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R0-CEP 2003-176 - Rev 00
    Expired
    Cefuroxime axetil, amorphous
    2005-06-23
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R0-CEP 2003-176 - Rev 00
    Status
    Expired
     
    Filing Details
    Cefuroxime axetil, amorphous
    Issue/Submission Date
    2005-06-23
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    Clavulanic Acid

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2012-392 - Rev 00
    Withdrawn by Holder
    Potassium clavulanate, diluted, wit...
    2018-11-05
    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    R1-CEP 2012-392 - Rev 00
    Status
    Withdrawn by Holder
     
    Filing Details
    Potassium clavulanate, diluted, wit...
    Issue/Submission Date
    2018-11-05
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    Clavulanic Acid

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    USDMF

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    CEP/COS

    Caution CEP/COS

    R1-CEP 1998-129 - Rev 08
    Withdrawn by Holder
    Potassium clavulanate
    2017-10-18
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 1998-129 - Rev 08
    Status
    Withdrawn by Holder
     
    Filing Details
    Potassium clavulanate
    Issue/Submission Date
    2017-10-18
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