Treats hypertension. ANDA 202130, held by Alembic. Telmisartan.
As of Nov 14, 2026, ANDA 202130 (Telmisartan), held by Alembic, was first approved by FDA on Jul 7, 2014, with 3 approved supplements and 0 published complete response letters.
Telmisartanis 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 is 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 |
|---|---|---|---|
| Jul 7, 2014 | Original application | Approved | None posted |
| Telmisartan20MG · tablet;oral | Telmisartan | Rx |
| Telmisartan40MG · tablet;oral | Telmisartan | Rx |
| Telmisartan80MG · tablet;oral | Telmisartan | Rx |
| Apr 16, 2019 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 8, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 25, 2014 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 7, 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
