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    Approved Drug Products containing Bepotastine listed in the FDA Orange Book. Original Data : FDA Website

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    FAMAR CDMO- From early development to commercial manufacturing.

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    xyz-pharma-m-2024-09-09

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    Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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    Veranova: A CDMO that manages complexity with confidence.

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    xyz-pharma-m-2024-09-09

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    Bepotastine

    ACTIVE PHARMA INGREDIENTS

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    FINISHED DOSAGE FORMULATIONS

    RELATED EXCIPIENT COMPANIES

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    01 1ALEMBIC

    02 1APOTEX

    03 1BAUSCH AND LOMB INC

    04 1MYLAN

    05 1SANDOZ INC

    06 1SOMERSET THERAPS LLC

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    01

    ALEMBIC

    India
    26th North American ISSX
    Not Confirmed
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    ALEMBIC

    India
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    26th North American ISSX
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code : AT

    BEPOTASTINE BESILATE

    Brand Name : BEPOTASTINE BESILATE

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 1.5%

    Approval Date : 2023-04-05

    Application Number : 214588

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

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    02

    APOTEX

    Canada
    26th North American ISSX
    Not Confirmed
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    APOTEX

    Canada
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    26th North American ISSX
    Not Confirmed
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    • EDQM
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    RLD : No

    TE Code : AT

    BEPOTASTINE BESILATE

    Brand Name : BEPOTASTINE BESILATE

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 1.5%

    Approval Date : 2019-03-05

    Application Number : 206066

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

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    03

    BAUSCH AND LOMB INC

    Canada
    26th North American ISSX
    Not Confirmed
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    BAUSCH AND LOMB INC

    Canada
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    26th North American ISSX
    Not Confirmed
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    • EDQM
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    RLD : Yes

    TE Code : AT

    BEPOTASTINE BESILATE

    Brand Name : BEPREVE

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 1.5%

    Approval Date : 2009-09-08

    Application Number : 22288

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code : AT

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    04

    SANDOZ INC

    Switzerland
    26th North American ISSX
    Not Confirmed
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    05

    SOMERSET THERAPS LLC

    U.S.A
    26th North American ISSX
    Not Confirmed
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    SOMERSET THERAPS LLC

    U.S.A
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    26th North American ISSX
    Not Confirmed
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    RLD :

    TE Code :

    BEPOTASTINE BESILATE

    Brand Name : BEPOTASTINE BESILATE

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 1.5%

    Approval Date :

    Application Number : 217770

    RX/OTC/DISCN :

    RLD :

    TE Code :

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    06

    MYLAN

    U.S.A
    26th North American ISSX
    Not Confirmed
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    MYLAN

    U.S.A
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    26th North American ISSX
    Not Confirmed
    • fda
    • EDQM
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    RLD : No

    TE Code : AT

    BEPOTASTINE BESILATE

    Brand Name : BEPOTASTINE BESILATE

    Dosage Form : SOLUTION/DROPS;OPHTHALMIC

    Dosage Strength : 1.5%

    Approval Date : 2019-03-18

    Application Number : 206220

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

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