SEREVENT
These highlights do not include all the information needed to use SEREVENT DISKUS safely and effectively. See full prescribing information for SEREVENT DISKUS.SEREVENT DISKUS (salmeterol xinafoate inhalation powder), for oral inhalation useInitial U.S. Approval: 1994
Approved
Approval ID
12d9728e-6b5c-4aee-bfb0-745e542ed2e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2022
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.
salmeterol xinafoate
PRODUCT DETAILS
NDC Product Code0173-0521
Application NumberNDA020692
Marketing CategoryC73594
Route of AdministrationRESPIRATORY (INHALATION), ORAL
Effective DateFebruary 25, 2022
Generic Namesalmeterol xinafoate
INGREDIENTS (2)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SALMETEROL XINAFOATEActive
Quantity: 50 ug in 1 1
Code: 6EW8Q962A5
Classification: ACTIM