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 five 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. 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

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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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