ANDA 208931, held by Aurobindo Pharma Ltd. Loratadine.
As of Nov 14, 2026, ANDA 208931 (Loratadine), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 29, 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: runny nose itchy, watery eyes sneezing itching of the nose or throat
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 29, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine1MG/ML · syrup;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
