Alvesco
These highlights do not include all the information needed to use ALVESCO safely and effectively. See full prescribing information for ALVESCO. Initial U.S. Approval: 2006
Approved
Approval ID
9f6112fb-78ef-43cf-8ae3-36370eb45468
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2023
Manufacturers
FDA
Covis Pharma US, Inc
DUNS: 118094829
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ciclesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70515-712
Application NumberNDA021658
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciclesonide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2022
FDA Product Classification
INGREDIENTS (3)
CICLESONIDEActive
Quantity: 160 ug in 1 1
Code: S59502J185
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ciclesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70515-711
Application NumberNDA021658
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciclesonide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateDecember 19, 2022
FDA Product Classification
INGREDIENTS (3)
CICLESONIDEActive
Quantity: 80 ug in 1 1
Code: S59502J185
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT