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FDA ANDA · ANDA205030

BLEOMYCIN

bleomycin sulfate

Sponsor: MEITHEAL

APPLICATION
ANDA205030
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-20
LATEST ACTION
2018-04-20
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

2018-04-20UNKNOWN · Original · standardAP
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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