QVAR REDIHALER
These highlights do not include all the information needed to use QVAR REDIHALER safely and effectively. See full prescribing information for QVAR REDIHALER. QVAR REDIHALER (beclomethasone dipropionate HFA) inhalation aerosol, for oral inhalation useInitial U.S. Approval: 1976
Approved
Approval ID
9fb78667-7db9-4d98-b8a2-0de60458de11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Beclomethasone Dipropionate HFA
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-2436
Application NumberNDA207921
Product Classification
M
Marketing Category
C73594
G
Generic Name
Beclomethasone Dipropionate HFA
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 28, 2023
FDA Product Classification
INGREDIENTS (3)
BECLOMETHASONE DIPROPIONATEActive
Quantity: 40 ug in 1 1
Code: 5B307S63B2
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
Beclomethasone Dipropionate HFA
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53002-3477
Application NumberNDA207921
Product Classification
M
Marketing Category
C73594
G
Generic Name
Beclomethasone Dipropionate HFA
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 28, 2023
FDA Product Classification
INGREDIENTS (3)
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
BECLOMETHASONE DIPROPIONATEActive
Quantity: 80 ug in 1 1
Code: 5B307S63B2
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT