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

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    Fluorouracil

    APIs // Active Pharmaceutical Ingredients

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    DOSSIERs // Finished Dosage Forms

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

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

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    01 DR REDDYS LABS SA (1)

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    01 CREAM;TOPICAL (8)

    02 INJECTABLE;INJECTION (50)

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    04 SOLUTION;TOPICAL (6)

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    01 DISCN (36)

    02 RX (28)

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    01 ADRUCIL (4)

    02 CARAC (1)

    03 EFUDEX (3)

    04 FLUOROPLEX (2)

    05 FLUOROURACIL (55)

    06 TOLAK (1)

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    01 No (55)

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    DR REDDYS LABS SA

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    FLUOROURACIL

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    CREAM;TOPICAL
    5%
    2008-04-11
    77524
    FLUOROURACIL
    RX
    No
    AB
    Dr Reddy Company Banner

    CPhI North America

    Attending

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    BAUSCH

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    FLUOROURACIL

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    SOLUTION;TOPICAL
    2%
    1982-01-01
    16831
    EFUDEX
    RX
    Yes
    AT
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    BAUSCH

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    FLUOROURACIL

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    SOLUTION;TOPICAL
    5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
    1982-01-01
    16831
    EFUDEX
    DISCN
    Yes
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    BAUSCH

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    FLUOROURACIL

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    CREAM;TOPICAL
    5%
    1982-01-01
    16831
    EFUDEX
    RX
    Yes
    AB
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    VALEANT PHARMS NORTH

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    FLUOROURACIL

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    CREAM;TOPICAL
    0.5%
    2000-10-27
    20985
    CARAC
    RX
    Yes
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    CHARTWELL RX

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    FLUOROURACIL

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    CREAM;TOPICAL
    1%
    1982-01-01
    16988
    FLUOROPLEX
    DISCN
    Yes
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    ELORAC

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      FLUOROURACIL

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      SOLUTION;TOPICAL
      1%
      1982-01-01
      16765
      FLUOROPLEX
      DISCN
      No
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      PHARMACIA AND UPJOHN

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      FLUOROURACIL

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      INJECTABLE;INJECTION
      50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
      1982-01-01
      17959
      ADRUCIL
      DISCN
      Yes
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      SPECTRUM PHARMS

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      FLUOROURACIL

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      INJECTABLE;INJECTION
      500MG/10ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
      1982-01-01
      12209
      FLUOROURACIL
      DISCN
      Yes
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      SPECTRUM PHARMS

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      FLUOROURACIL

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      INJECTABLE;INJECTION
      2.5GM/50ML (50MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
      2016-07-29
      12209
      FLUOROURACIL
      DISCN
      Yes
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