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 Initial U.S. Approval: 1996
Approved
Approval ID
97c91a09-98d0-4666-8448-0bd50c02bb14
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 3, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-214
Application NumberANDA212289
Product Classification
M
Marketing Category
C73584
G
Generic Name
AZELASTINE HYDROCHLORIDE
Product Specifications
Route of AdministrationNASAL
Effective DateFebruary 3, 2023
FDA Product Classification
INGREDIENTS (8)
SODIUM PHOSPHATE, DIBASIC DODECAHYDRATEInactive
Code: E1W4N241FO
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
AZELASTINE HYDROCHLORIDEActive
Quantity: 137 ug in 1 1
Code: 0L591QR10I
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT