Product Details for NDA 020459
REVEX (NALMEFENE HYDROCHLORIDE)
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NALMEFENE HYDROCHLORIDE
Proprietary Name: REVEX
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020459
Product Number: 001
Approval Date: Apr 17, 1995
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
REVEX (NALMEFENE HYDROCHLORIDE)
Proprietary Name: REVEX
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020459
Product Number: 001
Approval Date: Apr 17, 1995
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NALMEFENE HYDROCHLORIDE
Proprietary Name: REVEX
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020459
Product Number: 002
Approval Date: Apr 17, 1995
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: REVEX
Dosage Form; Route of Administration: SOLUTION; INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Strength: EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020459
Product Number: 002
Approval Date: Apr 17, 1995
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information