Treats chronic angina. ANDA 209081, held by Aurobindo Pharma. Ranolazine.
As of Nov 14, 2026, ANDA 209081 (Ranolazine), held by Aurobindo Pharma, was first approved by FDA on Dec 23, 2022, 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 |
|---|---|---|---|
| Dec 23, 2022 | 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
