Budesonide and Formoterol Fumarate Dihydrate
These highlights do not include all the information needed to use BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL safely and effectively. See full prescribing information for BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE INHALATION AEROSOL. BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE Inhalation Aerosol, for oral inhalation useInitial U.S. Approval: 2006
Approved
Approval ID
b974bab9-c6d2-41ad-b930-28f2904c5f9d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 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 Code50090-6382
Application NumberNDA021929
Marketing CategoryC73605
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJuly 24, 2019
Generic NameBudesonide and Formoterol Fumarate Dihydrate
INGREDIENTS (5)
BUDESONIDEActive
Quantity: 80 ug in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
FORMOTEROL FUMARATEActive
Quantity: 4.5 ug in 1 1
Code: W34SHF8J2K
Classification: ACTIR
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
APAFLURANEInactive
Code: R40P36GDK6
Classification: IACT