Treats chronic angina. ANDA 209953, held by Alkem Labs Ltd. Ranolazine.
As of Nov 14, 2026, ANDA 209953 (Ranolazine), held by Alkem Labs Ltd, was first approved by FDA on Nov 30, 2020, with 0 approved supplements and 0 published complete response letters.
Ranolazine extended-release tablets are indicated for the treatment of chronic angina. Ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. Ranolazine extended-release tablets are an antianginal indicated for the treatment of chronic angina.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 30, 2020 | 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
