Omnaris
These highlights do not include all the information needed to use OMNARIS safely and effectively. See full prescribing information for OMNARIS. Initial U.S. Approval: 2006
Approved
Approval ID
15fefd46-ac7e-40d0-b635-e6c3d653c666
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2022
Manufacturers
FDA
Covis Pharma US, Inc
DUNS: 118094829
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 Code70515-701
Application NumberNDA022004
Product Classification
M
Marketing Category
C73594
G
Generic Name
ciclesonide
Product Specifications
Route of AdministrationNASAL
Effective DateMarch 14, 2018
FDA Product Classification
INGREDIENTS (8)
CICLESONIDEActive
Quantity: 50 ug in 1 1
Code: S59502J185
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT