ANDA 76301, held by Perrigo. Loratadine.
As of Nov 14, 2026, ANDA 76301 (Loratadine), held by Perrigo, was first approved by FDA on Jun 25, 2004, 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 |
|---|---|---|---|
| Jun 25, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine10MG · tablet;oral | Loratadine | OTC |
| Sep 23, 2011 | Supplement 25Labeling | Approved | None posted |
| Mar 20, 2009 | Supplement 21Labeling | Approved | None posted |
| Jun 25, 2004 | 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
