Treats chronic angina. ANDA 213083, held by Unichem. Ranolazine.
As of Nov 14, 2026, ANDA 213083 (Ranolazine), held by Unichem, was first approved by FDA on Mar 16, 2023, 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 is an antianginal indicated for the treatment of chronic angina.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 16, 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
