ANDA 212930, held by Accord Hlthcare. Ranolazine.
As of Nov 14, 2026, ANDA 212930 (Ranolazine), held by Accord Hlthcare, was first approved by FDA on May 18, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 18, 2021 | Original application | Approved | None posted |
| Ranolazine500MG · tablet, extended release;oral | Ranolazine | Discontinued |
| Ranolazine1GM · tablet, extended release;oral | Ranolazine | Discontinued |
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
