SYMBICORT
These highlights do not include all the information needed to use SYMBICORT safely and effectively. See full prescribing information for SYMBICORT. SYMBICORT (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, for oral inhalation use Initial U.S. Approval: 2006
Approved
Approval ID
6b78d08a-e098-4188-8f7f-94fbd5f396ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Budesonide and Formoterol Fumarate Dihydrate
PRODUCT DETAILS
NDC Product Code50090-1403
Application NumberNDA021929
Marketing CategoryC73594
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateOctober 17, 2023
Generic NameBudesonide and Formoterol Fumarate Dihydrate
INGREDIENTS (5)
FORMOTEROL FUMARATEActive
Quantity: 4.5 ug in 1 1
Code: W34SHF8J2K
Classification: ACTIB
BUDESONIDEActive
Quantity: 160 ug in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
APAFLURANEInactive
Code: R40P36GDK6
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT