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Last Updated: April 23, 2024

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 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 021087

Tradename:	TAMIFLU
Applicant:	Roche
Ingredient:	oseltamivir phosphate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021087

Mechanism of Action	Neuraminidase Inhibitors

Medical Subject Heading (MeSH) Categories for 021087

Antiviral Agents
Enzyme 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	0004-0800-07	1 BOTTLE, PLASTIC in 1 CARTON (0004-0800-07) / 10 CAPSULE in 1 BOTTLE, PLASTIC
TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087	NDA	Genentech, Inc.	0004-0800	0004-0800-08	1 BOTTLE, PLASTIC in 1 CARTON (0004-0800-08) / 10 CAPSULE in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Oct 27, 1999	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 45MG BASE
Approval Date:	Jul 2, 2007	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 30MG BASE
Approval Date:	Jul 2, 2007	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021087

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999	⤷ Try a Trial	⤷ Try a Trial
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999	⤷ Try a Trial	⤷ Try a Trial
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-003	Jul 2, 2007	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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