Treats hypertension. ANDA 90032, held by Glenmark Pharms Ltd. Telmisartan.
As of Nov 14, 2026, ANDA 90032 (Telmisartan), held by Glenmark Pharms Ltd, was first approved by FDA on Jul 7, 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. 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 |
|---|---|---|---|
| Jul 7, 2014 | Original application | Approved | None posted |
| Telmisartan20MG · tablet;oral | Telmisartan | Rx |
| Telmisartan40MG · tablet;oral | Telmisartan | Rx |
| Telmisartan80MG · tablet;oral | Telmisartan | Rx |
| Apr 25, 2023 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 15, 2021 | Supplement 6Manufacturing | Approved | None posted |
| Mar 16, 2021 | Supplement 5Labeling · Standard review | Approved | None posted |
| Nov 17, 2015 | Supplement 2Labeling · 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
