NDA 21952, held by Bayer Healthcare LLC. Loratadine.
As of Nov 15, 2026, NDA 21952 (Claritin), held by Bayer Healthcare LLC, was first approved by FDA on Jun 16, 2008, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Claritin10MG · capsule;oral | Loratadine | OTCReference drug |
| May 9, 2025 | Supplement 24Manufacturing | Approved | |
| May 31, 2023 | Supplement 22Labeling · Standard review | Approved | |
| Dec 21, 2018 | Supplement 18Labeling · Standard review | Approved | |
| Jul 20, 2018 | Supplement 17Labeling · Standard review | Approved | |
| Jun 20, 2018 | Supplement 16Labeling · Standard review | Approved | |
| Jun 4, 2018 | Supplement 15Labeling · Standard review | Approved | |
| Apr 18, 2018 | Supplement 14Labeling · Standard review | Approved | |
| Dec 9, 2015 | Supplement 12Labeling · Standard review | Approved | |
| Apr 6, 2009 | Supplement 3Labeling · Standard review | Approved | |
| Jun 16, 2008 | Original applicationNew dosage form · 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
