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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 076931


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NDA 076931 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.
Summary for 076931
Tradename:BUPRENORPHINE HYDROCHLORIDE
Applicant:Hikma
Ingredient:buprenorphine hydrochloride
Patents:0
Pharmacology for NDA: 076931
Mechanism of ActionPartial Opioid Agonists
Suppliers and Packaging for NDA: 076931
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride INJECTABLE;INJECTION 076931 ANDA Hikma Pharmaceuticals USA Inc. 0143-9246 0143-9246-05 5 VIAL in 1 CARTON (0143-9246-05) / 1 mL in 1 VIAL (0143-9246-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.3MG BASE/ML
Approval Date:Mar 2, 2005TE:APRLD:No

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