Treats hypertension. ANDA 205150, held by Adaptis. Telmisartan.
As of Nov 14, 2026, ANDA 205150 (Telmisartan), held by Adaptis, was first approved by FDA on Oct 30, 2015, with 5 approved supplements and 0 published complete response letters.
Telmisartan tablets, USP 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, USP 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 |
|---|---|---|---|
| Oct 30, 2015 | Original application | Approved | None posted |
| Telmisartan20MG · tablet;oral | Telmisartan | Rx |
| Telmisartan40MG · tablet;oral | Telmisartan | Rx |
| Telmisartan80MG · tablet;oral | Telmisartan | Rx |
| Mar 3, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Jul 9, 2019 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 9, 2019 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 28, 2017 | Supplement 3Manufacturing | Approved | None posted |
| Mar 24, 2016 | Supplement 1Manufacturing | Approved | None posted |
| Oct 30, 2015 | 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
