ANDA 75990, held by Actavis Labs Fl Inc. Loratadine.
As of Nov 14, 2026, ANDA 75990 (Loratadine), held by Actavis Labs Fl Inc, was first approved by FDA on Nov 3, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 3, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG ยท tablet, orally disintegrating;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
