NDA 21734, held by Sun Pharma Canada. Loratadine.
As of Nov 15, 2026, NDA 21734 (Loratadine), held by Sun Pharma Canada, was first approved by FDA on Oct 4, 2005, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 4, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine1MG/ML · suspension;oral | Loratadine | DiscontinuedReference drug |
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
