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Serving leading biopharmaceutical companies globally:

UBS
Cipla
Mallinckrodt
Covington
Teva
Harvard Business School
QuintilesIMS
US Department of Justice
Farmers Insurance
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074137

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NDA 074137 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, and Teva Pharms Usa, and is included in nineteen NDAs. It is available from nineteen 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-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 074137
Tradename:BUPRENORPHINE HYDROCHLORIDE
Applicant:Hospira
Ingredient:buprenorphine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074137
Mechanism of ActionPartial Opioid Agonists
Suppliers and Packaging for NDA: 074137
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride INJECTABLE;INJECTION 074137 ANDA Hospira, Inc. 0409-2012 0409-2012-32 10 CARTRIDGE in 1 CARTON (0409-2012-32) > 1 mL in 1 CARTRIDGE (0409-2012-03)
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride INJECTABLE;INJECTION 074137 ANDA Rebel Distributors Corp 21695-515 21695-515-10 10 CARTRIDGE in 1 CARTON (21695-515-10) > 1 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.3MG BASE/ML
Approval Date:Jun 3, 1996TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Chubb
QuintilesIMS
Cipla
Boehringer Ingelheim
Queensland Health
Julphar
Citi
UBS
Mallinckrodt

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