Azelastine Hydrochloride
Azelastine Hydrochloride Nasal Solution 0.1% (Nasal Spray), 137 mcg/spray For Intranasal Use Only
Approved
Approval ID
666f0e35-577d-4ebf-b3ed-3660725f8277
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6131
Application NumberANDA077954
Product Classification
M
Marketing Category
C73584
G
Generic Name
azelastine hydrochloride
Product Specifications
Route of AdministrationNASAL
Effective DateJune 29, 2011
FDA Product Classification
INGREDIENTS (8)
azelastine hydrochlorideActive
Quantity: 137 ug in 1 1
Code: 0L591QR10I
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT