Treats hypertension. ANDA 78710, held by Chartwell Rx. Telmisartan.
As of Nov 14, 2026, ANDA 78710 (Telmisartan), held by Chartwell Rx, was first approved by FDA on Jan 8, 2014, 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. 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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 8, 2014 | Original application | Approved | None posted |
| Telmisartan20MG · tablet;oral | Telmisartan | Rx |
| Telmisartan40MG · tablet;oral | Telmisartan | Rx |
| Telmisartan80MG · tablet;oral | Telmisartan | Rx |
| May 1, 2023 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Apr 23, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 25, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 25, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 8, 2014 | 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
