ANDA 208174, held by Teva Pharms. Ranolazine.
As of Nov 14, 2026, ANDA 208174 (Ranolazine), held by Teva Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 12, 2016 | Original application | Tentative approval | None posted |
| Ranolazine500MG · tablet, extended release;oral | Ranolazine | None (tentative approval) |
| Ranolazine1000MG · tablet, extended release;oral | Ranolazine | 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