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Last Updated: December 5, 2019

DrugPatentWatch Database Preview

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 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. Nine 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 021083
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:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Sep 15, 1999TE:AARLD:Yes
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:TREATMENTOF LYMPHANGIOLEIOMYOMATOSIS (LAM)

Expired US Patents for NDA 021083

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

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