ANDA 211056, held by Ipca Labs Ltd. Irbesartan.
As of Nov 15, 2026, ANDA 211056 (Irbesartan), held by Ipca Labs Ltd, was first approved by FDA on May 22, 2024, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2024 | Original application | Approved | None posted |
| Irbesartan75MG · tablet;oral | Irbesartan | Discontinued |
| Irbesartan150MG · tablet;oral | Irbesartan | Discontinued |
| Irbesartan300MG · tablet;oral | Irbesartan | Discontinued |
| Sep 16, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 22, 2024 | Original application | 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
