APPLICATION
ANDA064117
TYPE
ANDA
ORIGINAL APPROVAL
1995-04-19
LATEST ACTION
2000-07-17
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
MITOMYCINPrescription
MITOMYCIN 40MG/VIAL · INJECTABLE · INJECTION
MITOMYCINDiscontinued
MITOMYCIN 5MG/VIAL · INJECTABLE · INJECTION
MITOMYCINPrescription
MITOMYCIN 20MG/VIAL · INJECTABLE · INJECTION
Approval history
2000-07-17Labeling · Supplement 5AP
1999-06-02Manufacturing (CMC) · Supplement 3AP
1999-06-02Manufacturing (CMC) · Supplement 1AP
1999-06-02Manufacturing (CMC) · Supplement 4AP
1999-06-02Labeling · Supplement 2AP
1995-04-19OriginalAP
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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