azelastine hydrochloride

FDA Drug Profile — Azelastine Hydrochloride, AZELASTINE HYDROCHLORIDE

azelastine hydrochloride is listed in the FDA National Drug Code directory with 8 NDC codes, marketed under brand names including Azelastine Hydrochloride, AZELASTINE HYDROCHLORIDE. Available dosage forms: spray, metered, solution/ drops.

Drug Details

Generic Name
azelastine hydrochloride
Brand Names
Azelastine Hydrochloride, AZELASTINE HYDROCHLORIDE
Application Number
ANDA077954
Sponsor
Apotex Corp.
NDC Codes
8
Dosage Forms
SPRAY, METERED, SOLUTION/ DROPS
Routes
NASAL, INTRAOCULAR, OPHTHALMIC
Active Ingredients
AZELASTINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. Azelastine hydrochloride and fluticasone propionate nasal spray contains an H 1 -receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in adult and pediatric patients 6 years of age and older. ( 1 )