ANDA 211707, held by Sun Pharm. Ranolazine.
As of Nov 14, 2026, ANDA 211707 (Ranolazine), held by Sun Pharm, was first approved by FDA on May 28, 2019, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 28, 2019 | Original application | Approved | None posted |
| Ranolazine500MG · tablet, extended release;oral | Ranolazine | Discontinued |
| Ranolazine1GM · tablet, extended release;oral | Ranolazine | Discontinued |
| Apr 29, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 31, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 28, 2019 | Original application | Approved | 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
