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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

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 three suppliers. Additional details are available on the TAMIFLU profile page.

The generic ingredient in TAMIFLU is oseltamivir phosphate. There are eight drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the oseltamivir phosphate profile page.
Summary for 021246
Tradename:TAMIFLU
Applicant:Roche
Ingredient:oseltamivir phosphate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021246
Suppliers and Packaging for NDA: 021246
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAMIFLU 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
TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246 NDA A-S Medication Solutions 50090-1244 50090-1244-0 1 BOTTLE, GLASS in 1 CARTON (50090-1244-0) > 60 mL in 1 BOTTLE, GLASS
Paragraph IV (Patent) Challenges for 021246
Tradename Dosage Ingredient NDA Submissiondate
TAMIFLU FOR SUSPENSION;ORAL oseltamivir phosphate 021246

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrengthEQ 12MG BASE/ML
Approval Date:Dec 14, 2000TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrengthEQ 6MG BASE/ML
Approval Date:Mar 21, 2011TE:ABRLD:Yes

Expired US Patents for NDA 021246

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-002 Mar 21, 2011   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000   Start Trial   Start Trial
Roche TAMIFLU oseltamivir phosphate FOR SUSPENSION;ORAL 021246-001 Dec 14, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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