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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 090622


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NDA 090622 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, Aveva, 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.
Summary for 090622
Tradename:BUPRENORPHINE HYDROCHLORIDE
Applicant:Ethypharm
Ingredient:buprenorphine hydrochloride
Patents:0
Pharmacology for NDA: 090622
Mechanism of ActionPartial Opioid Agonists
Suppliers and Packaging for NDA: 090622
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 090622 ANDA PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 0121-1019 0121-1019-30 30 TABLET in 1 BOTTLE (0121-1019-30)
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 090622 ANDA PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma 0121-2038 0121-2038-30 30 TABLET in 1 BOTTLE (0121-2038-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE
Approval Date:Sep 24, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE
Approval Date:Sep 24, 2010TE:ABRLD:No

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