ANDA 214367, held by Msn Laboratories Private Ltd. Selexipag.
As of Nov 14, 2026, ANDA 214367 (Selexipag), held by Msn Laboratories Private Ltd, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 16, 2026 | Original application | Tentative approval |
| Selexipag0.2MG · tablet;oral | Selexipag | None (tentative approval) |
| Selexipag0.4MG · tablet;oral | Selexipag | None (tentative approval) |
| Selexipag0.6MG · tablet;oral | Selexipag | None (tentative approval) |
| Selexipag0.8MG · tablet;oral | Selexipag | None (tentative approval) |
| Selexipag1MG · tablet;oral | Selexipag | None (tentative approval) |
| Selexipag1.2MG · tablet;oral | Selexipag | None (tentative approval) |
| Selexipag1.4MG · tablet;oral | Selexipag | None (tentative approval) |
| Selexipag1.6MG · tablet;oral | Selexipag | None (tentative approval) |
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
