ANDA 76529, held by Ranbaxy Labs Ltd. Loratadine.
As of Nov 14, 2026, ANDA 76529 (Loratadine), held by Ranbaxy Labs Ltd, was first approved by FDA on Aug 20, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2004 | Original application | Approved | None posted |
| 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
