ANDA 203161, held by Chartwell Rx. Irbesartan.
As of Nov 15, 2026, ANDA 203161 (Irbesartan), held by Chartwell Rx, was first approved by FDA on Sep 27, 2012, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 27, 2012 | Original application | Approved | None posted |
| Irbesartan75MG · tablet;oral | Irbesartan | Discontinued |
| Irbesartan150MG · tablet;oral | Irbesartan | Discontinued |
| Irbesartan300MG · tablet;oral | Irbesartan | Discontinued |
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
