ANDA 211718, held by Hetero Labs Ltd V. Loratadine.
As of Nov 14, 2026, ANDA 211718 (Loratadine), held by Hetero Labs Ltd V, was first approved by FDA on Jul 28, 2023, with 0 approved supplements and 0 published complete response letters.
USE(S) 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 |
|---|---|---|---|
| Jul 28, 2023 | 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
