NDA 208056, held by Takeda Pharms USA. Dexlansoprazole.
As of Nov 13, 2026, NDA 208056 (Dexilant Solutab), held by Takeda Pharms USA, was first approved by FDA on Jan 26, 2016, with 2 approved supplements and 0 published complete response letters.
| Jul 8, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 26, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dexilant Solutab30MG · tablet, orally disintegrating, delayed release;oral | Dexlansoprazole | DiscontinuedReference drug |
| Oct 24, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Jul 8, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 26, 2016 | 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
