Basic Information
Azelastine Hydrochloride
42291-094
Regulatory Information
42291-094
ANDA204660
C73584
January 9, 2024
USA
AZELASTINE HYDROCHLORIDE nasal spray, for intranasal use 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. Initial U.S. Approval: 1996
HUMAN PRESCRIPTION DRUG LABEL
3
Company Information
796560394
Active Ingredients
SODIUM PHOSPHATE
Code: SE337SVY37
Class Code: IACT
EDETATE DISODIUM
Code: 7FLD91C86K
Class Code: IACT
SODIUM CHLORIDE
Code: 451W47IQ8X
Class Code: IACT
BENZALKONIUM CHLORIDE
Code: F5UM2KM3W7
Class Code: IACT
ANHYDROUS CITRIC ACID
Code: XF417D3PSL
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
Active Moieties
AZELASTINE
Code: ZQI909440X