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McKinsey
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Generated: October 19, 2017

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-three suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.

Summary for NDA: 020732

Tradename:
1
Applicant:
1
Ingredient:
1
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 63629-4092-1 10 TABLET in 1 BOTTLE (63629-4092-1)
SUBUTEX
buprenorphine hydrochloride
TABLET;SUBLINGUAL 020732 ANDA bryant ranch prepack 63629-4092 63629-4092-2 30 TABLET in 1 BOTTLE (63629-4092-2)

Summary 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2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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

Summary 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8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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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Deloitte
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