ANDA 208477, held by Aurobindo Pharma Ltd. Loratadine.
As of Nov 14, 2026, ANDA 208477 (Loratadine), held by Aurobindo Pharma Ltd, was first approved by FDA on Apr 11, 2018, with 1 approved supplement and 0 published complete response letters.
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
| Dec 8, 2022 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Apr 11, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG · tablet, orally disintegrating;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
