ANDA 218393, held by Dr Reddys Labs Ltd. Siponimod.
As of Nov 14, 2026, ANDA 218393 (Siponimod), held by Dr Reddys Labs Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 5, 2025 | Original application | Tentative approval | 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