Treats heartburn and other symptoms associated GERD. ANDA 212652, held by Torrent. Esomeprazole Magnesium.
As of Nov 15, 2026, ANDA 212652 (Esomeprazole Magnesium), held by Torrent, was first approved by FDA on Mar 5, 2025, with 0 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 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 |
|---|---|---|---|
| Mar 5, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Esomeprazole MagnesiumEQ 10MG BASE/PACKET · for suspension, delayed release;oral | Esomeprazole Magnesium | Rx |
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
