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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 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 eighteen 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: 021083

Pf Prism Cv
Formulation / Manufacturing:see details

Pharmacology for NDA: 021083

Mechanism of ActionmTOR Inhibitors
Physiological EffectDecreased Immunologic Activity

Suppliers and Packaging for NDA: 021083

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 021083 NDA Wyeth Pharmaceuticals Inc., 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Sep 15, 1999TE:RLD:Yes
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Expired Orange Book Patents for NDA: 021083

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
SOLUTION;ORAL021083-001Sep 15, 19995,100,899*PED► subscribe
Pf Prism Cv
SOLUTION;ORAL021083-001Sep 15, 19995,403,833*PED► subscribe
Pf Prism Cv
SOLUTION;ORAL021083-001Sep 15, 19995,536,729*PED► subscribe
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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 verifification 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.