ANDA 77421, held by Lannett Co Inc. Loratadine.
As of Nov 14, 2026, ANDA 77421 (Loratadine), held by Lannett Co Inc, was first approved by FDA on Jun 29, 2006, with 2 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 |
|---|---|---|---|
| Jun 29, 2006 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine1MG/ML · syrup;oral | Loratadine | OTC |
| Nov 7, 2014 | Supplement 8Manufacturing | Approved | None posted |
| Aug 12, 2014 | Supplement 4Labeling | Approved | None posted |
| Jun 29, 2006 | 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
