NDA 20668, held by Astrazeneca. Enalapril Maleate; Felodipine.
As of Nov 13, 2026, NDA 20668 (Lexxel), held by Astrazeneca, was first approved by FDA on Dec 27, 1996, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 27, 1996 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lexxel5MG;5MG · tablet, extended release;oral | Enalapril Maleate; Felodipine | Discontinued |
| Lexxel5MG;2.5MG · tablet, extended release;oral | Enalapril Maleate; Felodipine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 4, 2007 | Supplement 13Labeling · Standard review | Approved | |
| Aug 2, 2005 | Supplement 5Labeling · Standard review | Approved | |
| Dec 23, 2004 | Supplement 12Labeling · Standard review | Approved | |
| Jun 7, 2004 | Supplement 11Labeling · Standard review | Approved | |
| Jun 11, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Sep 18, 2001 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 6, 2001 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 18, 2000 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 28, 1998 | Supplement 3Manufacturing · Standard review | Approved | |
| Jul 22, 1998 | Supplement 4Labeling · Standard review | Approved | |
| Mar 3, 1998 | Supplement 2Labeling · Standard review | Approved | |
| Jul 2, 1997 | Supplement 1Manufacturing · Standard review | Approved | |
| Dec 27, 1996 | Original applicationNew combination · 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
