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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 three suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the RAPAMUNE profile page.

The generic ingredient in RAPAMUNE is sirolimus. There are sixteen drug master file entries for this compound. Seven suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the sirolimus profile page.

Summary for NDA: 021110

Tradename:
RAPAMUNE
Applicant:
Pf Prism Cv
Ingredient:
sirolimus
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 021110

Mechanism of ActionmTOR Inhibitors
Physiological EffectDecreased Immunologic Activity

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 Inc., 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 Inc., 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 25, 2000TE:ABRLD:No
Patent:5,989,591*PEDPatent Expiration:Sep 11, 2018Product Flag?Substance Flag?Delist Request?Y
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 22, 2002TE:ABRLD:Yes
Patent:5,989,591*PEDPatent Expiration:Sep 11, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021110

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 20045,100,899*PED► subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 20025,308,847*PED► subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 20005,212,155*PED► subscribe
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