Details for New Drug Application (NDA): 022030

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NDA 022030 describes TOVIAZ, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TOVIAZ profile page.

The generic ingredient in TOVIAZ is fesoterodine fumarate. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.

Summary for 022030

Tradename:	TOVIAZ
Applicant:	Pfizer
Ingredient:	fesoterodine fumarate
Patents:	3

Suppliers and Packaging for NDA: 022030

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0242	0069-0242-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0242-30)
TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030	NDA	Pfizer Laboratories Div Pfizer Inc	0069-0244	0069-0244-30	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0244-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	4MG
Approval Date:	Oct 31, 2008	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 17, 2024
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Jun 17, 2024
Regulatory Exclusivity Use:	TREATMENT OF NEUROGENIC DETRUSOR OVERACTIVITY (NDO) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER AND WEIGHING GREATER THAN 25 KG
Patent:	⤷ Sign Up	Patent Expiration:	Dec 7, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022030

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	⤷ Sign Up	⤷ Sign Up
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	⤷ Sign Up	⤷ Sign Up
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	⤷ Sign Up	⤷ Sign Up
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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