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Details for New Drug Application (NDA): 021087

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NDA 021087 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 seven 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: 021087

Tradename:
TAMIFLU
Applicant:
Roche
Ingredient:
oseltamivir phosphate
Patents:3
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021087

Mechanism of ActionNeuraminidase Inhibitors

Suppliers and Packaging for NDA: 021087

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL 021087 NDA Genentech, Inc. 0004-0800 0004-0800-85 1 BLISTER PACK in 1 CARTON (0004-0800-85) > 10 CAPSULE in 1 BLISTER PACK
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL 021087 NDA Genentech, Inc. 0004-0801 0004-0801-85 1 BLISTER PACK in 1 CARTON (0004-0801-85) > 10 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Oct 27, 1999TE:ABRLD:Yes
Patent:5,763,483*PEDPatent Expiration:Feb 23, 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: 021087

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-003Jul 2, 20075,866,601*PED► subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-001Oct 27, 19995,866,601*PED► subscribe
Roche
TAMIFLU
oseltamivir phosphate
CAPSULE;ORAL021087-002Jul 2, 20075,952,375*PED► subscribe
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