APPLICATION
ANDA065031
TYPE
ANDA
ORIGINAL APPROVAL
2000-03-10
LATEST ACTION
2015-08-20
ROUTE
INTRAMUSCULAR, INTRAPLEURAL, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
BLEOMYCIN SULFATEPrescription
BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL · INJECTABLE · INJECTION
BLEOMYCIN SULFATEPrescription
BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL · INJECTABLE · INJECTION
Approval history
2015-08-20Labeling · Supplement 14 · standardAP
2013-06-17Labeling · Supplement 12 · standardAP
2005-06-07Labeling · Supplement 5AP
2001-05-14Manufacturing (CMC) · Supplement 2AP
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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