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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Boehringer Ingelheim
Express Scripts
US Army
UBS
Merck
Julphar
Colorcon
Cerilliant

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018401

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NDA 018401 describes BUPRENEX, which is a drug marketed by Indivior Inc and is included in one NDA. It is available from one supplier. Additional details are available on the BUPRENEX profile page.

The generic ingredient in BUPRENEX is buprenorphine hydrochloride. There are twenty-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.

Summary for NDA: 018401

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 018401

Mechanism of ActionPartial Opioid Agonists

Suppliers and Packaging for NDA: 018401

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENEX
buprenorphine hydrochloride
 INJECTABLE;INJECTION 018401 NDA Reckitt Benckiser Pharmaceuticals Inc 12496-0757 12496-0757-5 5 AMPULE in 1 CARTON (12496-0757-5) > 1 mL in 1 AMPULE (12496-0757-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.3MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Moodys
Express Scripts
Medtronic
US Department of Justice
Fish and Richardson
Deloitte
Harvard Business School
Farmers Insurance
Cantor Fitzgerald

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.

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