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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 five suppliers. There are eight 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 thirteen drug master file entries for this compound. Five suppliers are listed for this compound. There are twenty tentative approvals for this compound. Additional details are available on the fesoterodine fumarate profile page.

Summary for NDA: 022030

Tradename:
TOVIAZ
Applicant:
Pfizer
Ingredient:
fesoterodine fumarate
Patents:8

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength4MG
Approval Date:Oct 31, 2008TE:ABRLD:No
Patent:8,501,723Patent Expiration:Jun 7, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:6,858,650Patent Expiration:Jul 3, 2022Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY
Patent:7,384,980Patent Expiration:May 11, 2019Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND FREQUENCY


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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