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Details for New Drug Application (NDA): 021246

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NDA 021246 describes TAMIFLU, which is a drug marketed by Roche and is included in two NDAs. It is available from six suppliers. There are three patents protecting this drug and three Paragraph IV challenges. Additional details are available on the TAMIFLU profile page.

The generic ingredient in TAMIFLU is oseltamivir phosphate. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.

Summary for NDA: 021246

oseltamivir phosphate
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021246

Mechanism of ActionNeuraminidase Inhibitors

Suppliers and Packaging for NDA: 021246

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
oseltamivir phosphate
FOR SUSPENSION;ORAL 021246 NDA Genentech, Inc. 0004-0822 0004-0822-05 1 BOTTLE, GLASS in 1 CARTON (0004-0822-05) > 60 mL in 1 BOTTLE, GLASS
oseltamivir phosphate
FOR SUSPENSION;ORAL 021246 NDA Rebel Distributors Corp 42254-092 42254-092-60 1 BOTTLE, GLASS in 1 CARTON (42254-092-60) > 6 mL in 1 BOTTLE, GLASS

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 12MG BASE/ML
Approval Date:Dec 14, 2000TE:RLD:No
Patent:5,763,483*PEDPatent Expiration:Jun 27, 2017Product Flag?Substance Flag?Delist Request?Y
Patent:5,866,601*PEDPatent Expiration:Aug 2, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:5,952,375*PEDPatent Expiration:Aug 27, 2015Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021246

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-002Mar 21, 20115,866,601*PED<disabled>
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-001Dec 14, 20005,866,601*PED<disabled>
oseltamivir phosphate
FOR SUSPENSION;ORAL021246-002Mar 21, 20115,952,375*PED<disabled>
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