NDA 21993, held by Bayer Healthcare LLC. Loratadine.
As of Nov 14, 2026, NDA 21993 (Claritin Reditabs), held by Bayer Healthcare LLC, was first approved by FDA on Dec 12, 2006, 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 |
|---|---|---|---|
| Dec 12, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Claritin Reditabs5MG · tablet, orally disintegrating;oral | Loratadine | OTCReference drug |
| May 25, 2023 | Supplement 23Labeling · Standard review | Approved | |
| Feb 28, 2019 | Supplement 17Labeling · Standard review | Approved | |
| Jul 23, 2018 | Supplement 16Labeling · Standard review | Approved | |
| Nov 25, 2015 | Supplement 13Labeling · Standard review | Approved | |
| Jul 22, 2014 | Supplement 12Labeling · Standard review | Approved | |
| Oct 21, 2008 | Supplement 4Labeling · Standard review | Approved | |
| Dec 12, 2006 | Original applicationNew formulation or manufacturer · Standard review | 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
