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Details for New Drug Application (NDA): 021036

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

The generic ingredient in RELENZA is zanamivir. Three suppliers are listed for this compound. Additional details are available on the zanamivir profile page.

Summary for NDA: 021036

Tradename:
RELENZA
Applicant:
Glaxosmithkline
Ingredient:
zanamivir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021036

Mechanism of ActionNeuraminidase 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 Physicians Total Care, Inc. 54868-4377 54868-4377-0 5 PACKAGE in 1 CARTON (54868-4377-0) > 4 POWDER in 1 PACKAGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INHALATIONStrength5MG
Approval Date:Jul 26, 1999TE:RLD:Yes

Expired Orange Book Patents for NDA: 021036

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline
RELENZA
zanamivir
POWDER;INHALATION021036-001Jul 26, 19994,627,432► subscribe
Glaxosmithkline
RELENZA
zanamivir
POWDER;INHALATION021036-001Jul 26, 19995,360,817► subscribe
Glaxosmithkline
RELENZA
zanamivir
POWDER;INHALATION021036-001Jul 26, 19996,294,572► subscribe
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