APPLICATION
ANDA065033
TYPE
ANDA
ORIGINAL APPROVAL
2000-06-27
LATEST ACTION
2013-06-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
BLEOMYCIN SULFATEDiscontinued
BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL · INJECTABLE · INJECTION
BLEOMYCIN SULFATEDiscontinued
BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL · INJECTABLE · INJECTION
Approval history
2013-06-21Labeling · Supplement 23 · standardAP
2011-10-26Labeling · Supplement 17AP
2002-10-03Manufacturing (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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