ANDA 76824, held by Dr Reddys. Rabeprazole Sodium.
As of Nov 15, 2026, ANDA 76824 (Rabeprazole Sodium), held by Dr Reddys, was first approved by FDA on Nov 8, 2013, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 8, 2013 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rabeprazole Sodium20MG ยท 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
