ANDA 77153, held by Sun Pharm Inds Ltd. Loratadine.
As of Nov 14, 2026, ANDA 77153 (Loratadine Redidose), held by Sun Pharm Inds Ltd, was first approved by FDA on Apr 11, 2007, with 2 approved supplements and 0 published complete response letters.
USES Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 11, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine Redidose10MG · tablet, orally disintegrating;oral | Loratadine | OTC |
| Mar 3, 2020 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 26, 2014 | Supplement 6Labeling | Approved | None posted |
| Apr 11, 2007 | Original application | Approved | None posted |
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
