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Last Updated: August 19, 2022

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 two 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. Fifteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021110
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:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 25, 2000TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:TREATMENTOF LYMPHANGIOLEIOMYOMATOSIS (LAM)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 22, 2002TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:TREATMENTOF LYMPHANGIOLEIOMYOMATOSIS (LAM)

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:TREATMENTOF LYMPHANGIOLEIOMYOMATOSIS (LAM)

Expired US Patents for NDA 021110

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 See Plans and Pricing See Plans and Pricing
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-001 Aug 25, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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