Treats heartburn and other symptoms associated GERD. ANDA 211751, held by Cipla. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 211751 (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. Maintenance of healing of EE in adults. Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 2020 | Original application | Approved |
| Esomeprazole MagnesiumEQ 20MG BASE/PACKET · for suspension, delayed release;oral | Esomeprazole Magnesium | Rx |
| Esomeprazole MagnesiumEQ 40MG BASE/PACKET · for suspension, delayed release;oral | Esomeprazole Magnesium | Rx |
| Sep 11, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 11, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 11, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 11, 2023 | Supplement 6Labeling · 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
