Treats heartburn and other symptoms associated GERD. ANDA 206296, held by Zydus Pharms. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 206296 (Esomeprazole Magnesium), held by Zydus Pharms, was first approved by FDA on May 22, 2019, with 4 approved supplements and 0 published complete response letters.
Esomeprazole magnesium delayed-release capsules are 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 |
|---|---|---|---|
| May 22, 2019 | 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 |
| Feb 5, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 5, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 5, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 5, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 22, 2019 | 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
