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

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    Mitomycin

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    01 3ACCORD HLTHCARE

    02 2BRISTOL

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    05 3FRESENIUS KABI USA

    06 3GLAND PHARMA LTD

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    08 1HOSPIRA

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    01

    BRISTOL

    United Kingdom
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    BRISTOL

    United Kingdom
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    RLD : Yes

    TE Code :

    MITOMYCIN

    Brand Name : MUTAMYCIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1982-01-01

    Application Number : 50450

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    BRISTOL

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    RLD : Yes

    TE Code :

    MITOMYCIN

    Brand Name : MUTAMYCIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1982-01-01

    Application Number : 50450

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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    03

    BRISTOL MYERS

    U.S.A
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    RLD : No

    TE Code :

    MITOMYCIN

    Brand Name : MUTAMYCIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 5MG/VIAL

    Approval Date : 1982-01-01

    Application Number : 62336

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    BRISTOL MYERS

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    RLD : No

    TE Code :

    MITOMYCIN

    Brand Name : MUTAMYCIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 20MG/VIAL

    Approval Date : 1982-01-01

    Application Number : 62336

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    05

    BRISTOL MYERS

    U.S.A
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    RLD : No

    TE Code :

    MITOMYCIN

    Brand Name : MUTAMYCIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 40MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 1988-03-10

    Application Number : 62336

    RX/OTC/DISCN : DISCN

    RLD : No

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    HIKMA

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    RLD : No

    TE Code :

    MITOMYCIN

    Brand Name : MITOMYCIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 5MG/VIAL

    Approval Date : 1995-04-19

    Application Number : 64117

    RX/OTC/DISCN : DISCN

    RLD : No

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    HIKMA

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    RLD : No

    TE Code : AP

    MITOMYCIN

    Brand Name : MITOMYCIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 20MG/VIAL

    Approval Date : 1995-04-19

    Application Number : 64117

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    08

    HOSPIRA

    U.S.A
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    HOSPIRA

    U.S.A
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    RLD : No

    TE Code :

    MITOMYCIN

    Brand Name : MITOMYCIN

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 20MG/VIAL

    Approval Date : 1995-11-29

    Application Number : 64106

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    MOBIUS THERAP

    U.S.A
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    RLD : Yes

    TE Code :

    MITOMYCIN

    Brand Name : MITOSOL

    Dosage Form : FOR SOLUTION;TOPICAL

    Dosage Strength : 0.2MG/VIAL

    Approval Date : 2012-02-07

    Application Number : 22572

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    10

    SUPERGEN

    U.S.A
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    RLD : Yes

    TE Code :

    MITOMYCIN

    Brand Name : MITOZYTREX

    Dosage Form : INJECTABLE;INJECTION

    Dosage Strength : 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    Approval Date : 2002-11-14

    Application Number : 50763

    RX/OTC/DISCN : DISCN

    RLD : Yes

    TE Code :

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