NDA 209400, held by Dexcel. Omeprazole.
As of Nov 14, 2026, NDA 209400 (Omeprazole), held by Dexcel, was first approved by FDA on Jul 5, 2017, with 9 approved supplements and 0 published complete response letters.
Use
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 5, 2017 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Omeprazole20MG · tablet, orally disintegrating, delayed release;oral | Omeprazole | OTCReference drug |
| Mar 11, 2026 | Supplement 21Labeling · Standard review | Approved | |
| Oct 21, 2022 | Supplement 12Labeling · Standard review | Approved | |
| Jul 7, 2021 | Supplement 6Labeling · Standard review | Approved | |
| Nov 13, 2020 | Supplement 10Labeling · Standard review | Approved | |
| Apr 29, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Jan 28, 2019 | Supplement 5Labeling · Standard review | Approved | |
| Jul 12, 2018 | Supplement 3Labeling · Standard review | Approved | |
| Jun 12, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Feb 28, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Jul 5, 2017 | Original applicationNew dosage form · Standard review | Approved |
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
