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Generated: January 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022088

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NDA 022088 describes TORISEL, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TORISEL profile page.

The generic ingredient in TORISEL is temsirolimus. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the temsirolimus profile page.
Summary for 022088
Applicant:Pf Prism Cv
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:RXDosage:SOLUTION;INTRAVENOUSStrength25MG/ML (25MG/ML)
Approval Date:May 30, 2007TE:APRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 15, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jul 20, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jan 25, 2024Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

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