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FDA NDA · NDA050763

MITOZYTREX

Sponsor: SUPERGEN

APPLICATION
NDA050763
TYPE
NDA
ORIGINAL APPROVAL
2002-11-14
LATEST ACTION
2002-11-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MITOZYTREX · ReferenceDiscontinued
MITOMYCIN 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2002-11-14Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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