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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Cipla
Argus Health
Julphar
Chinese Patent Office
Healthtrust
Moodys
Johnson and Johnson
Citi

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205022

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NDA 205022 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Kremers Urban Pharms, Specgx Llc, Sun Pharm Inds Ltd, Teva Pharms Usa, and West-ward Pharms Int, and is included in eight NDAs. It is available from seventeen suppliers. Additional details are available on the BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE profile page.

The generic ingredient in BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 205022
Pharmacology for NDA: 205022
Suppliers and Packaging for NDA: 205022
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 205022 ANDA Lannett Company, Inc.. 62175-452 N 62175-452-32
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 205022 ANDA Lannett Company, Inc.. 62175-458 N 62175-458-32

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE;EQ 0.5MG BASE
Approval Date:Sep 19, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE;EQ 2MG BASE
Approval Date:Sep 19, 2016TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Merck
Covington
Julphar
Express Scripts
Teva
Johnson and Johnson
Federal Trade Commission
Cantor Fitzgerald

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