Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 2MG BASE;EQ 0.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203326
Product Number: 001
Approval Date: Jun 27, 2014
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:
Prescription
Patent and Exclusivity Information
Active Ingredient: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
Proprietary Name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 8MG BASE;EQ 2MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A203326
Product Number: 002
Approval Date: Jun 27, 2014
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status:
Prescription
Patent and Exclusivity Information