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Last Updated: April 19, 2024

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 two 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. Thirty-two 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 Action	Neuraminidase Inhibitors

Medical Subject Heading (MeSH) Categories for 021246

Antiviral Agents
Enzyme Inhibitors

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 12MG BASE/ML
Approval Date:	Dec 14, 2000	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	EQ 6MG BASE/ML
Approval Date:	Mar 21, 2011	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021246

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

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