Treats hypertension. ANDA 203325, held by Zydus Pharms. Telmisartan.
As of Nov 14, 2026, ANDA 203325 (Telmisartan), held by Zydus Pharms, was first approved by FDA on Aug 26, 2014, with 3 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. 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 |
|---|---|---|---|
| Aug 26, 2014 | Original application | Approved | None posted |
| Telmisartan20MG · tablet;oral | Telmisartan | Rx |
| Telmisartan40MG · tablet;oral | Telmisartan | Rx |
| Telmisartan80MG · tablet;oral | Telmisartan | Rx |
| Mar 21, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Apr 16, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 4, 2015 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 26, 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
