Omnaris
Approved
Approval ID
45e1c9d9-b8bc-4df9-acbb-d3a9c31a24b0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-6020
Application NumberNDA022004
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciclesonide
Product Specifications
Route of AdministrationNASAL
Effective DateMay 24, 2010
FDA Product Classification
INGREDIENTS (7)
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
CICLESONIDEActive
Quantity: 50 ug in 1 1
Code: S59502J185
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
EDETATE SODIUMInactive
Code: MP1J8420LU
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT