Last Updated: August 10, 2026

Details for New Drug Application (NDA): 078331

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NDA 078331 describes BUPRENORPHINE HYDROCHLORIDE, which is a drug marketed by Am Regent, Hikma, Hospira, Ph Health, Somerset Theraps Llc, Actavis Elizabeth, Ascent Pharms Inc, Barr, Ethypharm, Quagen, Rhodes Pharms, Rubicon Research, Specgx Llc, Sun Pharm, Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Alkem Labs Ltd, Amneal Pharms, Lannett Co Inc, Teva Pharms Usa, and Wes Pharma Inc, and is included in thirty-five NDAs. It is available from twenty-one suppliers. Additional details are available on the BUPRENORPHINE HYDROCHLORIDE profile page.

The generic ingredient in BUPRENORPHINE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for 078331

Tradename:	BUPRENORPHINE HYDROCHLORIDE
Applicant:	Am Regent
Ingredient:	buprenorphine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 0.3MG BASE/ML
Approval Date:	Mar 27, 2007	TE:		RLD:	No

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