BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
US Army
Express Scripts

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078331

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NDA 078331 describes BUPRENORPHINE HYDROCHLORIDE, which is a drug marketed by Hospira, Luitpold, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Ethypharm, Mylan Pharms Inc, Rhodes Pharms, Sandoz Inc, Sun Pharm Inds Ltd, Amneal Pharms, Ethypharm Usa Corp, Kremers Urban Pharms, Specgx Llc, and Teva Pharms Usa, and is included in twenty NDAs. It is available from eighteen 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-three suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 078331
Ingredient:buprenorphine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 078331
Mechanism of ActionPartial Opioid Agonists
Suppliers and Packaging for NDA: 078331
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride INJECTABLE;INJECTION 078331 ANDA American Regent, Inc. 0517-0725 N 0517-0725-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.3MG BASE/ML
Approval Date:Mar 27, 2007TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Queensland Health
Cantor Fitzgerald

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