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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212955

NALMEFENE HYDROCHLORIDE (NALMEFENE HYDROCHLORIDE)
EQ 2MG BASE/2ML (EQ 1MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: NALMEFENE HYDROCHLORIDE
Proprietary Name: NALMEFENE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 2MG BASE/2ML (EQ 1MG BASE/ML)
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AP
Application Number: A212955
Product Number: 001
Approval Date: Feb 8, 2022
Applicant Holder Full Name: PURDUE PHARMA LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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