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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. One supplier is listed for this compound. Additional details are available on the temsirolimus profile page.

Summary for NDA: 022088

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
SOLUTION;INTRAVENOUS 022088 NDA Wyeth Pharmaceuticals Inc., 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength25MG/ML (25MG/ML)
Approval Date:May 30, 2007TE:RLD:Yes
Patent:5,362,718*PEDPatent Expiration:Aug 15, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:8,026,276*PEDPatent Expiration:Jul 20, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:8,299,116*PEDPatent Expiration:Jan 25, 2024Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022088

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
SOLUTION;INTRAVENOUS022088-001May 30, 20075,362,718*PED<disabled>
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