Azelastine Hydrochloride
AZELASTINE nasal spray Initial U.S. Approval: 1996
Approved
Approval ID
c922833b-e10d-13a4-e053-2995a90abc88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 9, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-2497
Application NumberANDA077954
Product Classification
M
Marketing Category
C73584
G
Generic Name
azelastine hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateAugust 9, 2021
FDA Product Classification
INGREDIENTS (8)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMInactive
Code: GR686LBA74
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
AZELASTINE HYDROCHLORIDEActive
Quantity: 137 ug in 1 1
Code: 0L591QR10I
Classification: ACTIB