APPLICATION
ANDA202670
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-13
LATEST ACTION
2017-10-13
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MITOMYCINPrescription
MITOMYCIN 5MG/VIAL · INJECTABLE · INJECTION
MITOMYCINPrescription
MITOMYCIN 20MG/VIAL · INJECTABLE · INJECTION
Approval history
2017-10-13UNKNOWN · OriginalAP
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.