Treats chronic angina. ANDA 210188, held by Cadila. Ranolazine.
As of Nov 14, 2026, ANDA 210188 (Ranolazine), held by Cadila, was first approved by FDA on Aug 19, 2019, with 1 approved supplement and 0 published complete response letters.
Ranolazine extended-release tablet is indicated for the treatment of chronic angina. Ranolazine extended-release tablet 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 tablet is an antianginal indicated for the treatment of chronic angina.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 19, 2019 | Original application | Approved | None posted |
| Ranolazine500MG · tablet, extended release;oral | Ranolazine | Rx |
| Ranolazine1GM · tablet, extended release;oral | Ranolazine | Rx |
| Jan 22, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 19, 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
