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

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    Fomepizole

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    01 AM REGENT (1)

    02 GLAND PHARMA LTD (1)

    03 MYLAN INSTITUTIONAL (2)

    04 NAVINTA LLC (1)

    05 PAR PHARM INC (1)

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    01 INJECTABLE;INJECTION (6)

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    01 DISCN (2)

    02 RX (4)

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    01 ANTIZOL (1)

    02 FOMEPIZOLE (5)

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    01 No (5)

    02 Yes (1)

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    AM REGENT

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      FOMEPIZOLE

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      INJECTABLE;INJECTION
      1.5GM/1.5ML (1GM/ML)
      2007-12-14
      78368
      FOMEPIZOLE
      RX
      No
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      GLAND PHARMA LTD

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      FOMEPIZOLE

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      INJECTABLE;INJECTION
      1.5GM/1.5ML (1GM/ML)
      2023-07-06
      216791
      FOMEPIZOLE
      RX
      No
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      NAVINTA LLC

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        FOMEPIZOLE

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        INJECTABLE;INJECTION
        1.5GM/1.5ML (1GM/ML)
        2008-03-06
        78537
        FOMEPIZOLE
        RX
        No
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        PAR PHARM INC

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        FOMEPIZOLE

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        INJECTABLE;INJECTION
        1.5GM/1.5ML (1GM/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        1997-12-04
        20696
        ANTIZOL
        DISCN
        Yes
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        MYLAN INSTITUTIONAL

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        FOMEPIZOLE

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        INJECTABLE;INJECTION
        1.5GM/1.5ML (1GM/ML)
        2008-03-03
        78639
        FOMEPIZOLE
        RX
        No
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        MYLAN INSTITUTIONAL

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        FOMEPIZOLE

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        INJECTABLE;INJECTION
        1.5GM/1.5ML (1GM/ML)
        2009-04-07
        79033
        FOMEPIZOLE
        DISCN
        No
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