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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 018401


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NDA 018401 describes BUPRENEX, 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 BUPRENEX profile page.

The generic ingredient in BUPRENEX is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.
Summary for 018401
Tradename:BUPRENEX
Applicant:Indivior Inc
Ingredient:buprenorphine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 018401
Mechanism of ActionPartial Opioid Agonists
Suppliers and Packaging for NDA: 018401
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUPRENEX buprenorphine hydrochloride INJECTABLE;INJECTION 018401 NDA Indivior Inc. 12496-0757 12496-0757-5 5 AMPULE in 1 CARTON (12496-0757-5) > 1 mL in 1 AMPULE (12496-0757-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 0.3MG BASE/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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