Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Accenture
Cantor Fitzgerald
Daiichi Sankyo
Chubb
US Army
McKinsey
Novartis
Mallinckrodt
Fuji
Harvard Business School

Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201066

« Back to Dashboard

NDA 201066 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 201066
Tradename:BUPRENORPHINE HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:buprenorphine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201066
Mechanism of ActionPartial Opioid Agonists
Suppliers and Packaging for NDA: 201066
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 201066 ANDA Mylan Pharmaceuticals Inc. 0378-0923 N 0378-0923-93
BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 201066 ANDA Mylan Pharmaceuticals Inc. 0378-0924 N 0378-0924-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE
Approval Date:Mar 6, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE
Approval Date:Mar 6, 2015TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
US Army
Baxter
Argus Health
McKesson
AstraZeneca
Chubb
Fish and Richardson
US Department of Justice

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot