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 inhalationInitial U.S. Approval: 1999
Approved
Approval ID
315556f2-4da0-47fc-86af-8fb61f6dd3bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
zanamivir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4377
Application NumberNDA021036
Product Classification
M
Marketing Category
C73594
G
Generic Name
zanamivir
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 18, 2011
FDA Product Classification
INGREDIENTS (2)
ZANAMIVIRActive
Quantity: 5 mg in 1 1
Code: L6O3XI777I
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT