Treats hypertension. ANDA 208727, held by Aurobindo Pharma. Hydrochlorothiazide; Telmisartan.
As of Nov 15, 2026, ANDA 208727 (Telmisartan And Hydrochlorothiazide), held by Aurobindo Pharma, was first approved by FDA on Dec 15, 2016, with 3 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 |
|---|---|---|---|
| Dec 15, 2016 | 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 |
| Aug 25, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 25, 2023 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 13, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 15, 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
