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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210162

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NDA 210162 describes BUPRENORPHINE, which is a drug marketed by Amneal, Difgen Pharms, Mylan Tech Viatris, Strides Pharma Intl, Watson Labs Teva, Am Regent, Hikma, Hospira, Ph Health, Somerset Theraps Llc, Actavis Elizabeth, Barr, Ethypharm, Pharmobedient, Rhodes Pharms, Rubicon Research, Sun Pharm, Alvogen, 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-six NDAs. It is available from six suppliers. Additional details are available on the BUPRENORPHINE profile page.

The generic ingredient in BUPRENORPHINE 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.

Summary for 210162

Tradename:	BUPRENORPHINE
Applicant:	Mylan Tech Viatris
Ingredient:	buprenorphine
Patents:	0

Medical Subject Heading (MeSH) Categories for 210162

Analgesics, Opioid
Narcotic Antagonists
Narcotics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	5MCG/HR
Approval Date:	May 3, 2021	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	7.5MCG/HR
Approval Date:	May 3, 2021	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FILM, EXTENDED RELEASE;TRANSDERMAL			Strength	10MCG/HR
Approval Date:	May 3, 2021	TE:		RLD:	No

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