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 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. Thirty-five 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

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	A-S Medication Solutions	50090-0662	50090-0662-0	1 BLISTER PACK in 1 CARTON (50090-0662-0) / 10 CAPSULE in 1 BLISTER PACK
TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087	NDA	Redpharm Drug	67296-0131	67296-0131-1	1 BLISTER PACK in 1 CARTON (67296-0131-1) / 10 CAPSULE in 1 BLISTER PACK

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	021087-002	Jul 2, 2007	⤷ Sign Up	⤷ Sign Up
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-003	Jul 2, 2007	⤷ Sign Up	⤷ Sign Up
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999	⤷ Sign Up	⤷ Sign Up
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-001	Oct 27, 1999	⤷ Sign Up	⤷ Sign Up
Roche	TAMIFLU	oseltamivir phosphate	CAPSULE;ORAL	021087-003	Jul 2, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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