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FDA NDA · NDA218590

ZURNAI

nalmefene hydrochloride

Sponsor: KNOA PHARMA

APPLICATION
NDA218590
TYPE
NDA
ORIGINAL APPROVAL
2024-08-07
LATEST ACTION
2024-08-07
ROUTE
INTRAMUSCULAR, SUBCUTANEOUS, INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ZURNAI (AUTOINJECTOR) · ReferencePrescription
NALMEFENE HYDROCHLORIDE EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML) · SOLUTION · INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2024-08-07Type 3 - New Dosage Form · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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