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Generated: April 29, 2017

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Details for New Drug Application (NDA): 200063

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NDA 200063 describes CONTRAVE, which is a drug marketed by Orexigen and is included in one NDA. It is available from three suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CONTRAVE profile page.

The generic ingredient in CONTRAVE is bupropion hydrochloride; naltrexone hydrochloride. There are thirty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride; naltrexone hydrochloride profile page.

Summary for NDA: 200063

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 200063

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
bupropion hydrochloride; naltrexone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200063 NDA A-S Medication Solutions 50090-2868 50090-2868-0 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-2868-0)
bupropion hydrochloride; naltrexone hydrochloride
TABLET, EXTENDED RELEASE;ORAL 200063 NDA A-S Medication Solutions 50090-2945 50090-2945-0 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-2945-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG;8MG
Approval Date:Sep 10, 2014TE:RLD:Yes
Patent:7,375,111Patent Expiration:Mar 26, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:8,088,786Patent Expiration:Feb 3, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:7,462,626Patent Expiration:Jul 20, 2024Product Flag?Substance Flag?Delist Request?

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