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Julphar
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Johnson and Johnson
Federal Trade Commission
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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201066

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NDA 201066 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 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-two 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

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Citi
Colorcon
Dow
Accenture
Baxter
Chinese Patent Office
Fish and Richardson
QuintilesIMS

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