Application Nr Approved Date Route Status External Links
ANDA076447 2011-04-13 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Fexofenadine Hydrochloride Is An H1-Receptor Antagonist Indicated For: Relief Of Symptoms Associated With Seasonal Allergic Rhinitis In Patients ≥ 2 Years Of Age (1.1) Treatment Of Uncomplicated Skin Manifestations Of Chronic Idiopathic Urticaria In Patients ≥ 6 Months Of Age (1.2) 1.1 Seasonal Allergic Rhinitis Fexofenadine Hydrochloride Tablets Are Indicated For The Relief Of Symptoms Associated With Seasonal Allergic Rhinitis In Adults And Children 2 Years Of Age And Older. 1.2 Chronic Idiopathic Urticaria Fexofenadine Hydrochloride Tablets Are Indicated For Treatment Of Uncomplicated Skin Manifestations Of Chronic Idiopathic Urticaria In Adults And Children 6 Months Of Age And Older.

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
4. Ferric Oxide Red FERRIC OXIDE RED Molecular
5. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Fexofenadine Hydrochloride FEXOFENADINE HYDROCHLORIDE ZINC3824921

Comments