Treats hypertension. ANDA 204164, held by Jubilant Generics. Telmisartan.
As of Nov 14, 2026, ANDA 204164 (Telmisartan), held by Jubilant Generics, was first approved by FDA on Aug 22, 2016, with 2 approved supplements and 0 published complete response letters.
Telmisartan tablets, USP are 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 |
|---|---|---|---|
| Aug 22, 2016 | Original application | Approved | None posted |
| Telmisartan20MG · tablet;oral | Telmisartan | Rx |
| Telmisartan40MG · tablet;oral | Telmisartan | Rx |
| Telmisartan80MG · tablet;oral | Telmisartan | Rx |
| Mar 12, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 4, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 22, 2016 | 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
