ANDA 76011, held by Perrigo Pharma Intl. Loratadine.
As of Nov 14, 2026, ANDA 76011 (Loratadine), held by Perrigo Pharma Intl, was first approved by FDA on Sep 29, 2003, with 0 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 |
|---|---|---|---|
| Sep 29, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG · tablet, orally disintegrating;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
