Azelastine Hydrochloride
These highlights do not include all the information needed to use AZELASTINE HYDROCHLORIDE NASAL SPRAY safely and effectively. See full prescribing information for AZELASTINE HYDROCHLORIDE NASAL SPRAY.AZELASTINE HYDROCHLORIDE nasal spray, for intranasal use Initial U.S. Approval: 1996
Approved
Approval ID
fc69f672-17ec-4d86-b5af-086fd260b512
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2022
Manufacturers
FDA
Akorn
DUNS: 117696873
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azelastine Hydrochloride
PRODUCT DETAILS
NDC Product Code50383-942
Application NumberANDA210032
Marketing CategoryC73584
Route of AdministrationNASAL
Effective DateMarch 1, 2022
Generic NameAzelastine Hydrochloride
INGREDIENTS (8)
AZELASTINE HYDROCHLORIDEActive
Quantity: 1.5 mg in 1 mL
Code: 0L591QR10I
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT