APPLICATION
ANDA064106
TYPE
ANDA
ORIGINAL APPROVAL
1995-11-29
LATEST ACTION
2001-07-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
MITOMYCINDiscontinued
MITOMYCIN 20MG/VIAL · INJECTABLE · INJECTION
Approval history
2001-07-30Manufacturing (CMC) · Supplement 11AP
2001-05-14Manufacturing (CMC) · Supplement 10AP
2000-10-11Labeling · Supplement 8AP
2000-08-08Manufacturing (CMC) · Supplement 6AP
2000-07-12Manufacturing (CMC) · Supplement 7AP
2000-05-15Manufacturing (CMC) · Supplement 5AP
2000-05-12Manufacturing (CMC) · Supplement 4AP
1999-06-18Manufacturing (CMC) · Supplement 2AP
1995-11-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.