Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216007

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NALMEFENE HYDROCHLORIDE (NALMEFENE HYDROCHLORIDE)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Marketing Status: Prescription

Active Ingredient: NALMEFENE HYDROCHLORIDE
Proprietary Name: NALMEFENE HYDROCHLORIDE
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A216007
Product Number: 001
Approval Date: Nov 15, 2023
Applicant Holder Full Name: CHENGDU SHUODE PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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: No
TE Code: AP
Application Number: A216007
Product Number: 002
Approval Date: Nov 15, 2023
Applicant Holder Full Name: CHENGDU SHUODE PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information