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Last Updated: September 28, 2021

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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 three 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. Sixty-six suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.
Summary for 022497
Tradename:FORFIVO XL
Ingredient:bupropion hydrochloride
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 AUTHORIZED GENERIC Alvogen Inc. 47781-637 47781-637-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-637-30)
FORFIVO XL bupropion hydrochloride TABLET, EXTENDED RELEASE;ORAL 022497 NDA Almatica Pharma Inc. 52427-575 52427-575-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (52427-575-30)
Paragraph IV (Patent) Challenges for 022497
Tradename Dosage Ingredient NDA Submissiondate
FORFIVO XL TABLET, EXTENDED RELEASE;ORAL bupropion hydrochloride 022497 2013-02-28

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
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