NDA 20184, held by Symplmed Pharms LLC. Perindopril Erbumine.
As of Nov 13, 2026, NDA 20184 (Aceon), held by Symplmed Pharms LLC, was first approved by FDA on Dec 30, 1993, with 18 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 23, 2005 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Dec 30, 1993 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Aceon2MG · tablet;oral | Perindopril Erbumine | DiscontinuedReference drug |
| Aceon4MG · tablet;oral | Perindopril Erbumine | DiscontinuedReference drug |
| Aceon8MG · tablet;oral | Perindopril Erbumine | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 2017 | Supplement 23Labeling · Standard review | Approved | |
| Mar 30, 2015 | Supplement 22Labeling · Standard review | Approved | |
| Feb 26, 2013 | Supplement 20Labeling · Standard review | Approved | |
| Apr 11, 2012 | Supplement 19Labeling | Approved | |
| Aug 23, 2011 | Supplement 17Labeling | Approved | |
| Dec 10, 2010 | Supplement 15Labeling · Standard review | Approved | |
| Sep 3, 2008 | Supplement 13Labeling · Standard review | Approved | |
| Sep 3, 2008 | Supplement 14Labeling · Standard review | Approved | |
| Aug 23, 2005 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Oct 29, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Nov 20, 2002 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Aug 14, 2002 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1999 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 21, 1997 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1997 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 8, 1997 | Supplement 3Labeling · Standard review | Approved | |
| Nov 14, 1996 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| May 13, 1994 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1993 | Original applicationNew molecular entity · Standard review | 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
