ANDA 76471, held by Apotex. Loratadine.
As of Nov 14, 2026, ANDA 76471 (Loratadine), held by Apotex, was first approved by FDA on Feb 14, 2006, with 0 approved supplements and 0 published complete response letters.
Uses Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies runny nose itchy, watery eyes sneezing itching of the nose or throat
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 14, 2006 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG · tablet;oral | Loratadine | OTC |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
