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
ca94e217-1828-4a7f-b7c3-3352f00a97d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2020
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-2667
Application NumberNDA021929
Product Classification
M
Marketing Category
C73605
G
Generic Name
Budesonide and Formoterol Fumarate Dihydrate
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJuly 24, 2019
FDA Product Classification
INGREDIENTS (5)
BUDESONIDEActive
Quantity: 160 ug in 1 1
Code: Q3OKS62Q6X
Classification: ACTIB
POLYETHYLENE GLYCOL 1000Inactive
Code: U076Q6Q621
Classification: IACT
FORMOTEROL FUMARATEActive
Quantity: 4.5 ug in 1 1
Code: W34SHF8J2K
Classification: ACTIR
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
APAFLURANEInactive
Code: R40P36GDK6
Classification: IACT