Treats heartburn and other symptoms associated GERD. ANDA 210559, held by Indchemie Health. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 210559 (Esomeprazole Magnesium), held by Indchemie Health, was first approved by FDA on Feb 26, 2021, with 2 approved supplements and 0 published complete response letters.
Esomeprazole magnesium is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years 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 |
|---|---|---|---|
| Feb 26, 2021 | Original application | Approved | None posted |
| Esomeprazole MagnesiumEQ 20MG BASE · capsule, delayed rel pellets;oral | Esomeprazole Magnesium | Rx |
| Esomeprazole MagnesiumEQ 40MG BASE · capsule, delayed rel pellets;oral | Esomeprazole Magnesium | Rx |
| May 22, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 22, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 26, 2021 | Original application | Approved | None posted |
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
