Treats hypertension. ANDA 206194, held by Hisun Pharm Hangzhou. Irbesartan.
As of Nov 15, 2026, ANDA 206194 (Irbesartan), held by Hisun Pharm Hangzhou, was first approved by FDA on Jun 14, 2016, with 5 approved supplements and 0 published complete response letters.
1.1 Hypertension Irbesartan tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2016 | Original application | Approved | None posted |
| Irbesartan75MG · tablet;oral | Irbesartan | Rx |
| Irbesartan150MG · tablet;oral | Irbesartan | Rx |
| Irbesartan300MG · tablet;oral | Irbesartan | Rx |
| May 15, 2026 | Supplement 9Labeling · Standard review | Approved | None posted |
| Feb 16, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Feb 16, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 16, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 2, 2018 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 14, 2016 | 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
