Treats chronic angina. NDA 216018, held by Spil. Ranolazine.
As of Nov 14, 2026, NDA 216018 (Aspruzyo Sprinkle), held by Spil, was first approved by FDA on Feb 28, 2022, with 0 approved supplements and 0 published complete response letters.
ASPRUZYO Sprinkle is indicated for the treatment of chronic angina. ASPRUZYO Sprinkle may be used with beta-blockers, nitrates, calcium channel blockers, anti‑platelet therapy, lipid-lowering therapy, ACE inhibitors, and angiotensin receptor blockers. ASPRUZYO Sprinkle is an antianginal indicated for the treatment of chronic angina.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2022 | Original applicationNew dosage form · Standard review | Approved |
| Aspruzyo Sprinkle500MG · granule, extended release;oral | Ranolazine | DiscontinuedReference drug |
| Aspruzyo Sprinkle1GM · granule, extended release;oral | Ranolazine | DiscontinuedReference drug |
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
