Details for New Drug Application (NDA): 021083

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NDA 021083 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 021083

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

Pharmacology for NDA: 021083

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

Medical Subject Heading (MeSH) Categories for 021083

Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 021083

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RAPAMUNE	sirolimus	SOLUTION;ORAL	021083	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-1030	0008-1030-06	1 CARTON in 1 KIT (0008-1030-06) / 1 BOTTLE, GLASS in 1 CARTON (0008-1030-04) / 60 mL in 1 BOTTLE, GLASS
RAPAMUNE	sirolimus	SOLUTION;ORAL	021083	NDA AUTHORIZED GENERIC	Greenstone LLC	59762-1205	59762-1205-6	1 CARTON in 1 KIT (59762-1205-6) / 1 BOTTLE, GLASS in 1 CARTON (59762-1205-4) / 60 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Sep 15, 1999	TE:	AA	RLD:	Yes

Expired US Patents for NDA 021083

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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