ANDA 210409, held by Hetero Labs Ltd Iii. Loratadine.
As of Nov 14, 2026, ANDA 210409 (Loratadine), held by Hetero Labs Ltd Iii, was first approved by FDA on May 7, 2021, 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:
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 2021 | 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
