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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050763

MITOZYTREX (MITOMYCIN)
5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: MITOMYCIN
Proprietary Name: MITOZYTREX
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N050763
Product Number: 001
Approval Date: Nov 14, 2002
Applicant Holder Full Name: SUPERGEN INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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