APPLICATION
ANDA215687
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-20
LATEST ACTION
2021-10-20
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MITOMYCINPrescription
MITOMYCIN 5MG/VIAL · INJECTABLE · INJECTION
MITOMYCINPrescription
MITOMYCIN 20MG/VIAL · INJECTABLE · INJECTION
Approval history
2021-10-20UNKNOWN · Original · standardAP
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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