Alvesco
These highlights do not include all the information needed to use ALVESCO safely and effectively. See full prescribing information for ALVESCO.ALVESCO (ciclesonide) Inhalation Aerosol 80 mcg, 160 mcgFor Oral Inhalation OnlyInitial U.S. Approval: 2006
Approved
Approval ID
e4d92dc8-9bde-45af-a79f-13d80a812768
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2008
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5989
Application NumberNDA021658
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciclesonide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 15, 2010
FDA Product Classification
INGREDIENTS (3)
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
CICLESONIDEActive
Quantity: 80 ug in 1 1
Code: S59502J185
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ciclesonide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5990
Application NumberNDA021658
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciclesonide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 15, 2010
FDA Product Classification
INGREDIENTS (3)
CICLESONIDEActive
Quantity: 160 ug in 1 1
Code: S59502J185
Classification: ACTIB
NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT