Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 204431

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BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 2MG BASE;EQ 0.5MG BASE
Marketing Status: Prescription

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: A204431
Product Number: 001
Approval Date: Oct 16, 2015
Applicant Holder Full Name: ETHYPHARM USA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE)
EQ 8MG BASE;EQ 2MG BASE
Marketing Status: Prescription

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: No
TE Code: AB
Application Number: A204431
Product Number: 002
Approval Date: Oct 16, 2015
Applicant Holder Full Name: ETHYPHARM USA CORP
Marketing Status:  Prescription
Patent and Exclusivity Information