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FDA ANDA · ANDA065042

BLEOMYCIN

Sponsor: HIKMA

APPLICATION
ANDA065042
TYPE
ANDA
ORIGINAL APPROVAL
2001-10-17
LATEST ACTION
2011-08-30
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

2011-08-30Labeling · Supplement 6AP
2011-04-25Labeling · Supplement 5AP
2007-09-05Labeling · Supplement 4AP
2001-10-17OriginalLetterAP
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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