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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 218590

ZURNAI (AUTOINJECTOR) (NALMEFENE HYDROCHLORIDE)
EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)
Marketing Status: Prescription
Active Ingredient: NALMEFENE HYDROCHLORIDE
Proprietary Name: ZURNAI (AUTOINJECTOR)
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, SUBCUTANEOUS
Strength: EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N218590
Product Number: 001
Approval Date: Aug 7, 2024
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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