ANDA 210722, held by Granules. Loratadine.
As of Nov 14, 2026, ANDA 210722 (Loratadine), held by Granules, was first approved by FDA on Dec 23, 2019, with 0 approved supplements and 0 published complete response letters.
Uses 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 |
|---|---|---|---|
| Dec 23, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG · tablet;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
