ANDA 76154, held by Mylan. Loratadine.
As of Nov 14, 2026, ANDA 76154 (Loratadine), held by Mylan, was first approved by FDA on Aug 20, 2003, with 0 approved supplements and 0 published complete response letters.
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 |
|---|---|---|---|
| Aug 20, 2003 | Original application | Approved |
| 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
