ANDA 210088, held by Sun Pharm. Loratadine.
As of Nov 14, 2026, ANDA 210088 (Loratadine), held by Sun Pharm, was first approved by FDA on Apr 16, 2018, with 3 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 |
|---|---|---|---|
| Apr 16, 2018 | Original application | Approved |
| Loratadine5MG · tablet, chewable;oral | Loratadine | OTC |
| Loratadine10MG · tablet, chewable;oral | Loratadine | OTC |
| Apr 25, 2025 | Supplement 15Manufacturing | Approved | None posted |
| Oct 13, 2023 | Supplement 12Labeling · Standard review | Approved | None posted |
| Mar 5, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 16, 2018 | Original application | Approved |
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
