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.
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 022030-001 | 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 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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