ANDA 76134, held by Sun Pharm Inds Ltd. Loratadine.
As of Nov 14, 2026, ANDA 76134 (Loratadine), held by Sun Pharm Inds Ltd, was first approved by FDA on Aug 18, 2003, 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 |
|---|---|---|---|
| Aug 18, 2003 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG · tablet;oral | Loratadine | OTC |
| Mar 24, 2009 | Supplement 19Labeling | Approved | None posted |
| Apr 16, 2007 | Supplement 8Labeling | Approved | None posted |
| Mar 23, 2007 | Supplement 15Manufacturing | Approved | None posted |
| Aug 18, 2003 | 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
