Last Updated: November 9, 2026

Details for New Drug Application (NDA): 021036

NDA 021036 describes RELENZA, which is a drug marketed by Glaxosmithkline and is included in one NDA. It is available from two suppliers. Additional details are available on the RELENZA profile page.

The generic ingredient in RELENZA is zanamivir. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the zanamivir profile page.

Summary for 021036

Tradename:	RELENZA
Applicant:	Glaxosmithkline
Ingredient:	zanamivir
Patents:	0

Pharmacology for NDA: 021036

Mechanism of Action	Neuraminidase Inhibitors

Medical Subject Heading (MeSH) Categories for 021036

Antiviral Agents
Enzyme Inhibitors

Suppliers and Packaging for NDA: 021036

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RELENZA	zanamivir	POWDER;INHALATION	021036	NDA	GlaxoSmithKline LLC	0173-0681	0173-0681-01	5 PACKAGE in 1 CARTON (0173-0681-01) / 4 POWDER in 1 PACKAGE
RELENZA	zanamivir	POWDER;INHALATION	021036	NDA	GlaxoSmithKline LLC	0173-0681	0173-0681-22	5 PACKAGE in 1 CARTON (0173-0681-22) / 4 POWDER in 1 PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INHALATION			Strength	5MG
Approval Date:	Jul 26, 1999	TE:		RLD:	Yes

Expired US Patents for NDA 021036

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	⤷ Start Trial	⤷ Start Trial
Glaxosmithkline	RELENZA	zanamivir	POWDER;INHALATION	021036-001	Jul 26, 1999	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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