Application Nr Approved Date Route Status External Links
ANDA091444 2014-10-24 Nasal RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Azelastine Hydrochloride Nasal Spray Is Indicated For The Treatment Of The Symptoms Of Seasonal Allergic Rhinitis In Adults And Pediatric Patients 5 Years And Older, And For The Treatment Of The Symptoms Of Vasomotor Rhinitis In Adults And Adolescent Patients 12 Years And Older. Azelastine Hydrochloride Nasal Spray Is An H1-Receptor Antagonist Indicated For The Treatment Of The Symptoms Of Seasonal Allergic Rhinitis In Adults And Pediatric Patients 5 Years And Older And For The Treatment Of The Symptoms Of Vasomotor Rhinitis In Adults And Adolescent Patients 12 Years And Older. (1)

All Formulated Excipients (4 Total)

Name Structure Kind Function Status
1. Methyl Alcohol METHYL ALCOHOL Molecular
2. Anhydrous Citric Acid ANHYDROUS CITRIC ACID Molecular
3. Edetate Disodium EDETATE DISODIUM Molecular
4. Hypromelloses HYPROMELLOSES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Azelastine Hydrochloride AZELASTINE HYDROCHLORIDE ZINC601229

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