NDA 21961, held by Synthon Pharms. Simvastatin.
As of Nov 14, 2026, NDA 21961 (Simvastatin), held by Synthon Pharms, was first approved by FDA on Oct 9, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2007 | Original applicationNew dosage form · Standard review | Approved |
| Simvastatin10MG · tablet, orally disintegrating;oral | Simvastatin | DiscontinuedReference drug |
| Simvastatin20MG · tablet, orally disintegrating;oral | Simvastatin | DiscontinuedReference drug |
| Simvastatin40MG · tablet, orally disintegrating;oral | Simvastatin | DiscontinuedReference drug |
| Simvastatin80MG · tablet, orally disintegrating;oral | Simvastatin | 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
