Details for New Drug Application (NDA): 021110

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NDA 021110 describes RAPAMUNE, which is a drug marketed by Pf Prism Cv and is included in two NDAs. It is available from three suppliers. Additional details are available on the RAPAMUNE profile page.

The generic ingredient in RAPAMUNE is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.

Summary for 021110

Tradename:	RAPAMUNE
Applicant:	Pf Prism Cv
Ingredient:	sirolimus
Patents:	0

Pharmacology for NDA: 021110

Mechanism of Action	Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for 021110

Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 021110

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RAPAMUNE	sirolimus	TABLET;ORAL	021110	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-1040	0008-1040-05	100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05)
RAPAMUNE	sirolimus	TABLET;ORAL	021110	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-1040	0008-1040-10	100 BLISTER PACK in 1 CARTON (0008-1040-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Aug 25, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2MG
Approval Date:	Aug 22, 2002	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 23, 2004	TE:		RLD:	Yes

Expired US Patents for NDA 021110

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-002	Aug 22, 2002	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-003	Feb 23, 2004	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	RAPAMUNE	sirolimus	TABLET;ORAL	021110-004	Jan 25, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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