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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020732

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NDA 020732 describes SUBUTEX, 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 SUBUTEX profile page.

The generic ingredient in SUBUTEX is buprenorphine 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 profile page.
Summary for 020732
Tradename:SUBUTEX
Applicant:Indivior Inc
Ingredient:buprenorphine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020732
Mechanism of ActionPartial Opioid Agonists
Suppliers and Packaging for NDA: 020732
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUBUTEX buprenorphine hydrochloride TABLET;SUBLINGUAL 020732 ANDA bryant ranch prepack 63629-4092 E 63629-4092-1
SUBUTEX buprenorphine hydrochloride TABLET;SUBLINGUAL 020732 ANDA bryant ranch prepack 63629-4092 E 63629-4092-2

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 8, 2002TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Oct 8, 2002TE:RLD:Yes

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