Azelastine

FDA Drug Profile — Azelastine HCl, Azelastine Hydrochloride, Azelastine

Azelastine is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including Azelastine HCl, Azelastine Hydrochloride, Azelastine. Available dosage form: spray, metered.

Drug Details

Generic Name
Azelastine
Brand Names
Azelastine HCl, Azelastine Hydrochloride, Azelastine
Application Number
ANDA216576
Sponsor
Amneal Pharmaceuticals NY LLC
NDC Codes
4
Dosage Forms
SPRAY, METERED
Routes
NASAL
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 )