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Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020733

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NDA 020733 describes SUBOXONE, which is a drug marketed by Indivior Inc and is included in two NDAs. It is available from five suppliers. There are five patents protecting this drug and three Paragraph IV challenges. Additional details are available on the SUBOXONE profile page.

The generic ingredient in SUBOXONE is buprenorphine hydrochloride; naloxone 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; naloxone hydrochloride profile page.
Summary for 020733
Tradename:SUBOXONE
Applicant:Indivior Inc
Ingredient:buprenorphine hydrochloride; naloxone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020733
Suppliers and Packaging for NDA: 020733
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 020733 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-004 E 35356-004-30
SUBOXONE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 020733 NDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-004 E 35356-004-07

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;SUBLINGUALStrengthEQ 8MG BASE;EQ 2MG BASE
Approval Date:Oct 8, 2002TE:RLD:Yes

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