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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090622

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NDA 090622 describes BUPRENORPHINE HYDROCHLORIDE, which is a drug marketed by Hospira, Luitpold, Par Sterile Products, West-ward Pharms Int, Actavis Elizabeth, Barr, Casi Pharms Inc, Ethypharm, Mylan Pharms Inc, Rhodes Pharms, 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 sixteen 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 090622
Tradename:BUPRENORPHINE HYDROCHLORIDE
Applicant:Ethypharm
Ingredient:buprenorphine hydrochloride
Patents:0
Formulation / Manufacturing:see details
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 Lake Erie Medical DBA Quality Care Products LLC 35356-556 N 35356-556-30
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 090622 ANDA PD-Rx Pharmaceuticals, Inc. 43063-667 N 43063-667-06

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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