Last Updated: September 28, 2026

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 one supplier. Additional details are available on the RAPAMUNE profile page.

The generic ingredient in RAPAMUNE is sirolimus. There is one drug master file entry for this compound. Twenty 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
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 AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 59762-1001 59762-1001-1 100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1001-1)
RAPAMUNE sirolimus TABLET;ORAL 021110 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 59762-1002 59762-1002-1 100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1002-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 25, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 22, 2002TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Feb 23, 2004TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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