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RELENZA

These highlights do not include all the information needed to use RELENZA safely and effectively. See full prescribing information for RELENZA. RELENZA (zanamivir inhalation powder), for oral inhalation useInitial U.S. Approval: 1999

Approved
Approval ID

d7c3bcc3-0c0d-4068-fd80-88cf54a376ef

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 24, 2023

Manufacturers
FDA

GlaxoSmithKline LLC

DUNS: 167380711

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

zanamivir

PRODUCT DETAILS

NDC Product Code0173-0681
Application NumberNDA021036
Marketing CategoryC73594
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 19, 2021
Generic Namezanamivir

INGREDIENTS (2)

ZANAMIVIRActive
Quantity: 5 mg in 1 1
Code: L6O3XI777I
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
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RELENZA - FDA Approval | MedPath