NDA 213593, held by Azurity. Omeprazole; Sodium Bicarbonate.
As of Nov 13, 2026, NDA 213593 (Konvomep), held by Azurity, was first approved by FDA on Aug 30, 2022, with 0 approved supplements and 1 published complete response letter.
KONVOMEP is indicated in adults for: short-term treatment (4 to 8 weeks) of active benign gastric ulcer. reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients. KONVOMEP is a combination of omeprazole, a proton pump inhibitor (PPI) and sodium bicarbonate, indicated in adults for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2022 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jan 28, 2021 | Omeprazole and sodium bicarbonateProduct Quality, Clinical | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Konvomep2MG/ML;84MG/ML · for suspension;oral | Omeprazole; Sodium Bicarbonate | RxReference drug |
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
