ANDA 210668, held by Novast Labs. Ranolazine.
As of Nov 14, 2026, ANDA 210668 (Ranolazine), held by Novast Labs, was first approved by FDA on Sep 27, 2023, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2023 | Original application | Approved | None posted |
| Ranolazine500MG · tablet, extended release;oral | Ranolazine | Rx |
| Ranolazine1GM · tablet, extended release;oral | Ranolazine | Rx |
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
