NDA 21456, held by Eisai Medcl Res. Rabeprazole Sodium.
As of Nov 14, 2026, NDA 21456 (Aciphex), held by Eisai Medcl Res, was first approved by FDA on Nov 8, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 8, 2002 | Original applicationTYPE 6 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aciphex20MG · tablet, delayed release; oral | Rabeprazole Sodium | Rx |
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
