NDA 206679, held by Salerno Pharms. Simvastatin.
As of Nov 13, 2026, NDA 206679 (Flolipid), held by Salerno Pharms, was first approved by FDA on Apr 21, 2016, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 21, 2016 | Original applicationNew dosage form · Standard review | Approved |
| Flolipid20MG/5ML · suspension;oral | Simvastatin | RxReference drug |
| Flolipid40MG/5ML · suspension;oral | Simvastatin | RxReference drug |
| Sep 25, 2020 | Supplement 3Labeling | Approved | |
| Oct 4, 2017 | Supplement 2Labeling · Standard review | Approved | |
| Apr 21, 2016 | Original applicationNew dosage form · Standard review | Approved |
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
