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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203136

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NDA 203136 describes BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Amneal Pharms, Ethypharm Usa Corp, Kremers Urban Pharms, Sun Pharm Inds Ltd, Teva Pharms Usa, and West-ward Pharms Int, 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-nine 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 203136

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 203136

Suppliers and Packaging for NDA: 203136

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 203136 ANDA Mallinckrodt, Inc. 0406-1923 0406-1923-03 30 TABLET in 1 BOTTLE (0406-1923-03)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 203136 ANDA Mallinckrodt, Inc. 0406-1923 0406-1923-09 90 TABLET in 1 BOTTLE (0406-1923-09)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE;EQ 0.5MG BASE
Approval Date:Feb 22, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE;EQ 2MG BASE
Approval Date:Feb 22, 2013TE:ABRLD:No


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