AZELASTINE HYDROCHLORIDE
478 - Nasal Spray Azelastine Hydrochloride
Approved
Approval ID
3e2fdb0d-c2f5-41ab-b1cd-4fae80648112
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 2, 2025
Manufacturers
FDA
Allegiant Health
DUNS: 079501930
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 Code69168-478
Application NumberANDA216421
Marketing CategoryC73584
Route of AdministrationNASAL
Effective DateMay 2, 2025
Generic NameAZELASTINE HYDROCHLORIDE
INGREDIENTS (8)
AZELASTINE HYDROCHLORIDEActive
Quantity: 205.5 ug in 1 1
Code: 0L591QR10I
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT