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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022497

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NDA 022497 describes FORFIVO XL, which is a drug marketed by Alvogen and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the FORFIVO XL profile page.

The generic ingredient in FORFIVO XL is bupropion hydrochloride. There are thirty-eight drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 022497
Tradename:FORFIVO XL
Applicant:Alvogen
Ingredient:bupropion hydrochloride
Patents:1
Therapeutic Class:Antidepressants
Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022497
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FORFIVO XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497 NDA Edgemont Pharmaceuticals, LLC 49909-010 N 49909-010-30
FORFIVO XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497 NDA Almatica Pharma Inc. 52427-575 N 52427-575-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength450MG
Approval Date:Nov 10, 2011TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 25, 2027Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Harvard Business School
Teva
Fish and Richardson
Moodys
Julphar
US Department of Justice
Express Scripts
Mallinckrodt

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