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Last Updated: May 14, 2021

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Details for New Drug Application (NDA): 206953

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NDA 206953 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Mayne Pharma Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Teva Pharms Usa, and Wes Pharma Inc, and is included in sixteen NDAs. It is available from nineteen suppliers. Additional details are available on the BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE profile page.

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

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE;EQ 0.5MG BASE
Approval Date:Jul 17, 2020TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE;EQ 2MG BASE
Approval Date:Jul 17, 2020TE:RLD:No

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