NDA 208025, held by Dexcel. Lansoprazole.
As of Nov 13, 2026, NDA 208025 (Lansoprazole), held by Dexcel, was first approved by FDA on Jun 7, 2016, with 9 approved supplements and 0 published complete response letters.
Use
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 2016 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lansoprazole15MG · tablet, orally disintegrating, delayed release;oral | Lansoprazole | OTC |
| Mar 11, 2026 | Supplement 18Labeling · Standard review | Approved | |
| Nov 1, 2022 | Supplement 12Labeling · Standard review | Approved | |
| Nov 20, 2020 | Supplement 10Labeling · Standard review | Approved | |
| Apr 9, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Nov 30, 2017 | Supplement 7Labeling · Standard review | Approved | |
| Nov 30, 2017 | Supplement 6Manufacturing | Approved | |
| Nov 15, 2017 | Supplement 5Labeling · Standard review | Approved | |
| May 9, 2017 | Supplement 3Labeling · Standard review | Approved | |
| Jan 25, 2017 | Supplement 1Labeling · Standard review | Approved | |
| Jun 7, 2016 | Original applicationNew formulation or manufacturer · 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
