Treats heartburn and other symptoms associated GERD. ANDA 211752, held by Cipla. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 211752 (Esomeprazole Magnesium), held by Cipla, was first approved by FDA on Mar 23, 2020, with 4 approved supplements and 0 published complete response letters.
Esomeprazole magnesium for delayed release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed release oral suspension is indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 1 year to 17 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age. Maintenance of healing of EE in adults. Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 1 year to 17 years of age.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Esomeprazole MagnesiumEQ 10MG BASE/PACKET · for suspension, delayed release;oral | Esomeprazole Magnesium | Rx |
| Sep 11, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 11, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 11, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 11, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 23, 2020 | Original application | 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
