Treats hypertension. ANDA 206511, held by Aurobindo Pharma. Telmisartan.
As of Nov 14, 2026, ANDA 206511 (Telmisartan), held by Aurobindo Pharma, was first approved by FDA on Sep 3, 2015, with 4 approved supplements and 0 published complete response letters.
Telmisartan tablets are an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Cardiovascular (CV) risk reduction in patients unable to take ACE inhibitors 1.1 Hypertension Telmisartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 2015 | Original application | Approved |
| Telmisartan20MG · tablet;oral | Telmisartan | Rx |
| Telmisartan40MG · tablet;oral | Telmisartan | Rx |
| Telmisartan80MG · tablet;oral | Telmisartan | Rx |
| Jun 9, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jun 9, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jun 9, 2023 | Supplement 14Labeling · Standard review | Approved | None posted |
| Apr 2, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 3, 2015 | Original application | 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
