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Generated: November 12, 2018

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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 five suppliers. 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. Twenty-one 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
Pharmacology for NDA: 021246
Mechanism of ActionNeuraminidase Inhibitors
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 Rebel Distributors Corp 42254-092 42254-092-60 1 BOTTLE, GLASS in 1 CARTON (42254-092-60) > 6 mL in 1 BOTTLE, GLASS

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

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
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Cerilliant
Deloitte
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UBS
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Chubb
Queensland Health

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