Application Nr Approved Date Route Status External Links
ANDA076805 2004-08-20 Oral OTC Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Purpose Antihistamine

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Citric Acid Monohydrate CITRIC ACID MONOHYDRATE Molecular
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Water WATER Molecular
5. Sodium Benzoate SODIUM BENZOATE Molecular
6. Sodium Metabisulfite SODIUM METABISULFITE Unresolved BC-Boiler compound , PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
7. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Loratadine LORATADINE ZINC537931

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