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FDA ANDA · ANDA065185

BLEOMYCIN

bleomycin sulfate

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA065185
TYPE
ANDA
ORIGINAL APPROVAL
2008-01-28
LATEST ACTION
2011-11-08
ROUTE
INTRAMUSCULAR, INTRAPLEURAL, INTRAVENOUS, SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BLEOMYCIN SULFATEPrescription
BLEOMYCIN SULFATE EQ 15 UNITS BASE/VIAL · INJECTABLE · INJECTION
BLEOMYCIN SULFATEPrescription
BLEOMYCIN SULFATE EQ 30 UNITS BASE/VIAL · INJECTABLE · INJECTION

Approval history

2011-11-08Labeling · Supplement 3AP
2011-04-25Labeling · Supplement 2AP
2008-01-28OriginalAP
VIEW ON DRUGS@FDA ↗

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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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