ANDA 77752, held by Rising. Simvastatin.
As of Nov 13, 2026, ANDA 77752 (Simvastatin), held by Rising, was first approved by FDA on Dec 20, 2006, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2006 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Simvastatin10MG · tablet;oral | Simvastatin | Rx |
| Simvastatin20MG · tablet;oral | Simvastatin | Rx |
| Simvastatin40MG · tablet;oral | Simvastatin | Rx |
| Simvastatin80MG · tablet;oral | Simvastatin | Rx |
| Simvastatin5MG · tablet;oral | Simvastatin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 5, 2015 | Supplement 22Labeling · Standard review | Approved | None posted |
| Nov 3, 2014 | Supplement 21Labeling · Standard review | Approved | None posted |
| Nov 3, 2014 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jan 29, 2013 | Supplement 19Labeling · Standard review | Approved | None posted |
| Apr 30, 2012 | Supplement 18Labeling | Approved | None posted |
| Jan 11, 2012 | Supplement 17Labeling | Approved | None posted |
| Jul 25, 2011 | Supplement 16Labeling | Approved | None posted |
| Dec 21, 2010 | Supplement 15Labeling | Approved | None posted |
| Sep 27, 2010 | Supplement 14Labeling | Approved | None posted |
| Apr 30, 2010 | Supplement 13Labeling | Approved | None posted |
| Sep 10, 2008 | Supplement 9Labeling | Approved | None posted |
| Feb 6, 2008 | Supplement 4Labeling | Approved | None posted |
| Dec 20, 2006 | Original application | Approved | None posted |
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
