Application Nr Approved Date Route Status External Links
ANDA077498 2007-12-27 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Antihistamine

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Povidones POVIDONES Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE ZINC19364229

Comments