DYMISTA
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 2012
Approved
Approval ID
4c557ec4-c4cf-11df-851a-0800200c9a66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 8, 2022
Manufacturers
FDA
Meda Pharmaceuticals Inc.
DUNS: 051229602
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azelastine Hydrochloride and Fluticasone Propionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0037-0245
Application NumberNDA202236
Product Classification
M
Marketing Category
C73594
G
Generic Name
Azelastine Hydrochloride and Fluticasone Propionate
Product Specifications
Route of AdministrationNASAL
Effective DateAugust 8, 2022
FDA Product Classification
INGREDIENTS (10)
FLUTICASONE PROPIONATEActive
Quantity: 50 ug in 1 1
Code: O2GMZ0LF5W
Classification: ACTIB
AZELASTINE HYDROCHLORIDEActive
Quantity: 137 ug in 1 1
Code: 0L591QR10I
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
PHENYLETHYL ALCOHOLInactive
Code: ML9LGA7468
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT