ANDA 76805, held by Taro. Loratadine.
As of Nov 14, 2026, ANDA 76805 (Loratadine), held by Taro, was first approved by FDA on Aug 20, 2004, with 6 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 20, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Loratadine1MG/ML · syrup;oral | Loratadine | OTC |
| Aug 19, 2014 | Supplement 20Labeling | Approved | None posted |
| Aug 19, 2014 | Supplement 19Labeling | Approved | None posted |
| Apr 21, 2011 | Supplement 25Manufacturing | Approved | None posted |
| Aug 31, 2009 | Supplement 17Labeling | Approved | None posted |
| Mar 3, 2008 | Supplement 4Labeling | Approved | None posted |
| Sep 19, 2007 | Supplement 2Labeling | Approved | None posted |
| Aug 20, 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
