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Cantor Fitzgerald
Julphar
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Dow
Moodys
Boehringer Ingelheim
Fuji
US Army
Chinese Patent Office

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204431

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NDA 204431 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Sun Pharm Inds Ltd, Teva Pharms Usa, and West-ward Pharms Int, and is included in eight NDAs. It is available from seventeen 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.
Summary for 204431
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 N 50383-287-93
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204431 ANDA Hi-Tech Pharmacal Co. Inc. 50383-294 N 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

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