➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Dow
Moodys
McKinsey
McKesson

Last Updated: May 14, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204431

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 204431 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Alvogen Pine Brook, Dr Reddys Labs Sa, Mylan Technologies, Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Mayne Pharma Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Teva Pharms Usa, and Wes Pharma Inc, and is included in sixteen NDAs. It is available from nineteen 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.
Pharmacology for NDA: 204431
Suppliers and Packaging for NDA: 204431
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 204431 ANDA Hi-Tech Pharmacal Co. Inc. 50383-287 50383-287-93 30 TABLET in 1 BOTTLE, PLASTIC (50383-287-93)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204431 ANDA Hi-Tech Pharmacal Co. Inc. 50383-294 50383-294-93 30 TABLET in 1 BOTTLE, PLASTIC (50383-294-93)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE;EQ 0.5MG BASE
Approval Date:Oct 16, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE;EQ 2MG BASE
Approval Date:Oct 16, 2015TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Colorcon
McKesson
McKinsey
Johnson and Johnson
Baxter

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 verification 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.