Details for New Drug Application (NDA): 021083

✉ Email this page to a colleague

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. Nineteen 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

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	5,536,729*PED	⤷ Subscribe
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	5,100,899*PED	⤷ Subscribe
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	5,403,833*PED	⤷ Subscribe
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	5,308,847*PED	⤷ Subscribe
Pf Prism Cv	RAPAMUNE	sirolimus	SOLUTION;ORAL	021083-001	Sep 15, 1999	5,212,155*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.