NDA 202342, held by Belcher. Esomeprazole Strontium.
As of Nov 14, 2026, NDA 202342 (Esomeprazole Strontium), held by Belcher, was first approved by FDA on Aug 6, 2013, with 5 approved supplements and 0 published complete response letters.
1.INDICATIONS & USAGE SECTION 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) in Adults Healing of Erosive Esophagitis Esomeprazole strontium is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of esomeprazole strontium may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2013 | Original applicationNew active ingredient · Standard review | Approved |
| Esomeprazole Strontium24.65MG · capsule, delayed release;oral | Esomeprazole Strontium | DiscontinuedReference drug |
| Esomeprazole Strontium49.3MG · capsule, delayed release;oral | Esomeprazole Strontium | DiscontinuedReference drug |
| Mar 4, 2022 | Supplement 7Labeling · Standard review | Approved | |
| Nov 27, 2020 | Supplement 6Labeling · Standard review | Approved | |
| Jun 7, 2018 | Supplement 5Labeling · Standard review | Approved | |
| Oct 24, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Dec 19, 2014 | Supplement 2Labeling | Approved | |
| Aug 6, 2013 | Original applicationNew active ingredient · 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
