Details for New Drug Application (NDA): 022497

NDA 022497 describes FORFIVO XL, which is a drug marketed by Twi Pharms 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-three suppliers are listed for this compound. Additional details are available on the bupropion hydrochloride profile page.

Summary for 022497

Tradename:	FORFIVO XL
Applicant:	Twi Pharms
Ingredient:	bupropion hydrochloride
Patents:	1

Pharmacology for NDA: 022497

Mechanism of Action	Dopamine Uptake Inhibitors Norepinephrine Uptake Inhibitors
Physiological Effect	Increased Dopamine Activity Increased Norepinephrine Activity

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	Upsher-Smith Laboratories, LLC	24979-247	24979-247-06	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-247-06)
FORFIVO XL	bupropion hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022497	NDA AUTHORIZED GENERIC	Upsher-Smith Laboratories, LLC	24979-248	24979-248-06	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (24979-248-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	450MG
Approval Date:	Nov 10, 2011	TE:		RLD:	Yes
Patent:	7,674,479	Patent Expiration:	Aug 23, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

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