ANDA 75505, held by Teva. Loratadine.
As of Nov 14, 2026, ANDA 75505 (Loratadine), held by Teva, was first approved by FDA on Nov 7, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 7, 2003 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine1MG/ML ยท syrup;oral | Loratadine | Discontinued |
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
