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Last Updated: March 28, 2024

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. Fourteen 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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength4MG
Approval Date:Oct 31, 2008TE:ABRLD: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:⤷  Try a TrialPatent Expiration:Dec 7, 2027Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 022030

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

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