Details for New Drug Application (NDA): 022088
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The generic ingredient in TORISEL is temsirolimus. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the temsirolimus profile page.
Summary for 022088
Tradename: | TORISEL |
Applicant: | Pf Prism Cv |
Ingredient: | temsirolimus |
Patents: | 5 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022088
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088 | NDA | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 0008-1179 | 0008-1179-01 | 1 KIT in 1 CARTON (0008-1179-01) * 25 mL in 1 VIAL, SINGLE-USE (0008-1279-01) * 1.8 mL in 1 VIAL, SINGLE-USE (0008-1125-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 25MG/ML (25MG/ML) | ||||
Approval Date: | May 30, 2007 | TE: | AP | RLD: | Yes | ||||
Patent: | See Plans and Pricing | Patent Expiration: | Jul 20, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | See Plans and Pricing | Patent Expiration: | Jan 25, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | See Plans and Pricing | Patent Expiration: | Jan 25, 2024 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 022088
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | See Plans and Pricing | See Plans and Pricing |
Pf Prism Cv | TORISEL | temsirolimus | SOLUTION;INTRAVENOUS | 022088-001 | May 30, 2007 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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