ANDA 202538, held by Bionpharma. Loratadine.
As of Nov 14, 2026, ANDA 202538 (Loratadine), held by Bionpharma, was first approved by FDA on Dec 21, 2018, with 0 approved supplements and 0 published complete response letters.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 21, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG · capsule;oral | Loratadine | OTC |
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
