ANDA 218459, held by Aurobindo Pharma Ltd. Siponimod.
As of Nov 14, 2026, ANDA 218459 (Siponimod), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 6, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 2026 | Original application | Approved | None posted |
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
