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Generated: September 23, 2018

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Details for New Drug Application (NDA): 064144

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NDA 064144 describes MITOMYCIN, which is a drug marketed by Accord Hlthcare, Hospira, Mylan Labs Ltd, and West-ward Pharms Int, and is included in six NDAs. It is available from three suppliers. Additional details are available on the MITOMYCIN profile page.

The generic ingredient in MITOMYCIN is mitomycin. There are seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
Summary for 064144
Tradename:MITOMYCIN
Applicant:Accord Hlthcare
Ingredient:mitomycin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 064144
Mechanism of ActionAlkylating Activity
Suppliers and Packaging for NDA: 064144
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MITOMYCIN mitomycin INJECTABLE;INJECTION 064144 ANDA Accord Healthcare Inc 16729-108 16729-108-11 1 VIAL in 1 BOX, UNIT-DOSE (16729-108-11) > 40 mL in 1 VIAL
MITOMYCIN mitomycin INJECTABLE;INJECTION 064144 ANDA Accord Healthcare Inc 16729-115 16729-115-05 1 VIAL in 1 CARTON (16729-115-05) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/VIAL
Approval Date:Apr 30, 1998TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/VIAL
Approval Date:Apr 30, 1998TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/VIAL
Approval Date:Aug 11, 2009TE:APRLD:No

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