Treats hypertension. ANDA 207882, held by Prinston. Telmisartan.
As of Nov 14, 2026, ANDA 207882 (Telmisartan), held by Prinston, was first approved by FDA on May 3, 2017, with 4 approved supplements and 0 published complete response letters.
Telmisartan is 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 |
|---|---|---|---|
| May 3, 2017 | Original application | Approved | None posted |
| Telmisartan20MG · tablet;oral | Telmisartan | Rx |
| Telmisartan40MG · tablet;oral | Telmisartan | Rx |
| Telmisartan80MG · tablet;oral | Telmisartan | Rx |
| Jun 26, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 10, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 10, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 10, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 3, 2017 | 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
