APPLICATION
ANDA064144
TYPE
ANDA
ORIGINAL APPROVAL
1998-04-30
LATEST ACTION
2023-08-16
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
MITOMYCINPrescription
MITOMYCIN 20MG/VIAL · INJECTABLE · INJECTION
MITOMYCINPrescription
MITOMYCIN 40MG/VIAL · INJECTABLE · INJECTION
MITOMYCINPrescription
MITOMYCIN 5MG/VIAL · INJECTABLE · INJECTION
Approval history
2023-08-16Labeling · Supplement 21 · standardAP
2011-07-11Labeling · Supplement 11AP
2009-12-02Labeling · Supplement 7AP
2009-08-11Efficacy · Supplement 5AP
2009-08-11Labeling · Supplement 6AP
2009-04-01Labeling · Supplement 4AP
2001-02-28Labeling · Supplement 2AP
1999-02-22Manufacturing (CMC) · Supplement 1AP
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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