ANDA 203685, held by Ajanta Pharma Ltd. Irbesartan.
As of Nov 15, 2026, ANDA 203685 (Irbesartan), held by Ajanta Pharma Ltd, was first approved by FDA on Dec 10, 2015, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 10, 2015 | 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
