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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

Tradename:
TORISEL
Applicant:
Pf Prism Cv
Ingredient:
temsirolimus
Patents:7
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 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


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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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