ANDA 76532, held by Teva Pharms. Simvastatin.
As of Nov 13, 2026, ANDA 76532 (Simvastatin), held by Teva Pharms, was not approved, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 2005 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Simvastatin5MG · tablet; oral | Simvastatin | None (tentative approval) |
| Simvastatin10MG · tablet; oral | Simvastatin | None (tentative approval) |
| Simvastatin20MG · tablet; oral | Simvastatin | None (tentative approval) |
| Simvastatin40MG · tablet; oral | Simvastatin | None (tentative approval) |
| Simvastatin80MG · tablet; oral | Simvastatin | None (tentative approval) |
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