NDA 21268, held by Abbvie. Eprosartan Mesylate; Hydrochlorothiazide.
As of Nov 14, 2026, NDA 21268 (Teveten Hct), held by Abbvie, was first approved by FDA on Nov 1, 2001, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 1, 2001 | Original applicationNew combination · Standard review | Approved |
| Teveten Hct600MG;12.5MG · tablet;oral | Eprosartan Mesylate; Hydrochlorothiazide | Discontinued |
| Teveten Hct600MG;25MG · tablet;oral | Eprosartan Mesylate; Hydrochlorothiazide | Discontinued |
| Jul 22, 2014 | Supplement 19Labeling · Standard review | Approved | |
| Sep 12, 2012 | Supplement 18Labeling | Approved | |
| Jan 19, 2012 | Supplement 17Labeling | Approved | |
| May 19, 2011 | Supplement 15Labeling | Approved | |
| May 19, 2011 | Supplement 16Labeling | Approved | |
| Jul 11, 2005 | Supplement 9Manufacturing · Standard review | Approved | |
| Oct 16, 2003 | Supplement 2Labeling · Standard review | Approved | |
| Jul 7, 2003 | Supplement 6Manufacturing · Standard review | Approved | |
| Sep 27, 2002 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Nov 1, 2001 | Original applicationNew combination · 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
