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FDA ANDA · ANDA076755

FLUMAZENIL

Sponsor: BAXTER HLTHCARE CORP

APPLICATION
ANDA076755
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-12
LATEST ACTION
2016-08-26
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

FLUMAZENILPrescription
FLUMAZENIL 0.5MG/5ML (0.1MG/ML) · INJECTABLE · INJECTION
FLUMAZENILPrescription
FLUMAZENIL 1MG/10ML (0.1MG/ML) · INJECTABLE · INJECTION

Approval history

2016-08-26Manufacturing (CMC) · Supplement 13 · unknownAP
2004-10-12OriginalAP
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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