Details for New Drug Application (NDA): 211594

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NDA 211594 describes BUPRENORPHINE HYDROCHLORIDE, which is a drug marketed by Alvogen, Am Regent, Endo Operations, Hikma, Hospira, Actavis Elizabeth, Barr, Ethypharm, Norvium Bioscience, Rhodes Pharms, Rubicon, Sun Pharm, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Teva Pharms Usa, and Wes Pharma Inc, and is included in thirty-one NDAs. It is available from twenty 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-four suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Tradename:	BUPRENORPHINE HYDROCHLORIDE
Applicant:	Alvogen
Ingredient:	buprenorphine hydrochloride
Patents:	0

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM;BUCCAL			Strength	EQ 0.075MG BASE
Approval Date:	Aug 3, 2021	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM;BUCCAL			Strength	EQ 0.15MG BASE
Approval Date:	Aug 3, 2021	TE:		RLD:	No

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM;BUCCAL			Strength	EQ 0.3MG BASE
Approval Date:	Aug 3, 2021	TE:		RLD:	No

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