Application Nr Approved Date Route Status External Links
ANDA202039 2014-11-19 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Antihistamine

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Anhydrous Lactose ANHYDROUS LACTOSE Molecular
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Starch, Corn STARCH, CORN Unresolved
4. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
5. Hypromelloses HYPROMELLOSES Unresolved
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. Polyethylene Glycol 400 POLYETHYLENE GLYCOL 400 Unresolved
8. Ferric Oxide Red FERRIC OXIDE RED Molecular
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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