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

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    Bismuth Subsalicylate

    ACTIVE PHARMA INGREDIENTS

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    01 1CASPER PHARMA LLC

    02 1NOSTRUM LABS INC

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    01

    CASPER PHARMA LLC

    U.S.A
    AAPS 2024
    Not Confirmed
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    CASPER PHARMA LLC

    U.S.A
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    AAPS 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : Yes

    TE Code :

    BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

    Brand Name : HELIDAC

    Dosage Form : TABLET, CHEWABLE, TABLET, CAPSULE;ORAL

    Dosage Strength : 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1996-08-15

    Application Number : 50719

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    02

    NOSTRUM LABS INC

    U.S.A
    AAPS 2024
    Not Confirmed
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    NOSTRUM LABS INC

    U.S.A
    arrow
    AAPS 2024
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    RLD : No

    TE Code :

    BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

    Brand Name : BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

    Dosage Form : TABLET, CHEWABLE, TABLET, CAPSULE;ORAL

    Dosage Strength : 262.4MG, N/A, N/A;N/A, 250MG, N/A;N/A, N/A, 500MG

    Approval Date : 2018-11-30

    Application Number : 202584

    RX/OTC/DISCN : RX

    RLD : No

    TE Code :

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