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Serving 500+ biopharmaceutical companies globally:

Citi
Novartis
Cantor Fitzgerald
AstraZeneca
Julphar
Merck
Chinese Patent Office
Cipla
Daiichi Sankyo
Boehringer Ingelheim

Generated: June 24, 2017

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, Kremers Urban Pharms, West-ward Pharms Int, Ethypharm Usa Corp, Sun Pharm Inds Ltd, Amneal Pharms, and Teva Pharms Usa, and is included in seven NDAs. It is available from fifteen 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-eight 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 NDA: 205022

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

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 Kremers Urban Pharmaceuticals Inc. 62175-452 62175-452-32 30 TABLET in 1 BOTTLE (62175-452-32)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL 205022 ANDA Kremers Urban Pharmaceuticals Inc. 62175-458 62175-458-32 30 TABLET in 1 BOTTLE (62175-458-32)

Summary for product number 001

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

Summary 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 500+ biopharmaceutical companies globally:

Baxter
Teva
Moodys
Fuji
Boehringer Ingelheim
Cipla
Farmers Insurance
Deloitte
Julphar
Dow

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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