ANDA 78735, held by Tp Anda Holdings. Simvastatin.
As of Nov 13, 2026, ANDA 78735 (Simvastatin), held by Tp Anda Holdings, was first approved by FDA on Aug 30, 2010, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Simvastatin5MG · tablet;oral | Simvastatin | Rx |
| Simvastatin10MG · tablet;oral | Simvastatin | Rx |
| Simvastatin20MG · tablet;oral | Simvastatin | Rx |
| Simvastatin40MG · tablet;oral | Simvastatin | Rx |
| Simvastatin80MG · tablet;oral | Simvastatin | 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
