ANDA 215127, held by Catalent Pharma. Loratadine.
As of Nov 14, 2026, ANDA 215127 (Loratadine), held by Catalent Pharma, was first approved by FDA on Feb 28, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG ยท capsule;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
