NDA 21512, held by Perrigo. Loratadine.
As of Nov 14, 2026, NDA 21512 (Loratadine), held by Perrigo, was first approved by FDA on Jun 24, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 24, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG · tablet;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
