Treats hypertension. ANDA 202544, held by Glenmark Pharms Ltd. Hydrochlorothiazide; Telmisartan.
As of Nov 15, 2026, ANDA 202544 (Telmisartan And Hydrochlorothiazide), held by Glenmark Pharms Ltd, was first approved by FDA on Mar 4, 2019, with 2 approved supplements and 0 published complete response letters.
Telmisartan and hydrochlorothiazide 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 classes to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with telmisartan and hydrochlorothiazide tablets.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2019 | Original application | Approved | None posted |
| Telmisartan And Hydrochlorothiazide12.5MG;40MG · tablet;oral | Hydrochlorothiazide; Telmisartan | Rx |
| Telmisartan And Hydrochlorothiazide12.5MG;80MG · tablet;oral | Hydrochlorothiazide; Telmisartan | Rx |
| Telmisartan And Hydrochlorothiazide25MG;80MG · tablet;oral | Hydrochlorothiazide; Telmisartan | Rx |
| Jul 12, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 24, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 4, 2019 | 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
