Treats active duodenal ulcer. ANDA 203481, held by Breckenridge. Omeprazole.
As of Nov 15, 2026, ANDA 203481 (Omeprazole), held by Breckenridge, was first approved by FDA on Jul 3, 2017, with 4 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE Omeprazole delayed-release capsules, USP, are a proton pump inhibitor (PPI) indicated for the: Treatment of active duodenal ulcer in adults Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults Treatment of active benign gastric ulcer in adults Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older Maintenance of healing of EE due to acid-mediated GERD in patients 2 years of age and older Pathologic hypersecretory conditions in adults 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 3, 2017 | Original application | Approved | None posted |
| Omeprazole10MG · capsule, delayed rel pellets;oral | Omeprazole | Rx |
| Omeprazole20MG · capsule, delayed rel pellets;oral | Omeprazole | Rx |
| Omeprazole40MG · capsule, delayed rel pellets;oral | Omeprazole | Rx |
| Jul 18, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Mar 4, 2022 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 11, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 7, 2018 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 3, 2017 | 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
