Manages hypertension. ANDA 78164, held by Aurobindo Pharma. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 78164 (Hydrochlorothiazide), held by Aurobindo Pharma, was first approved by FDA on Sep 19, 2007, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrochlorothiazide capsules are indicated in the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Unlike potassium sparing combination diuretic products, hydrochlorothiazide capsules may be used in those patients in whom the development of hyperkalemia cannot be risked, including patients taking ACE inhibitors. Usage in Pregnancy: The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 19, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrochlorothiazide12.5MG · capsule;oral | Hydrochlorothiazide | Rx |
| Apr 4, 2024 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 28, 2014 | Supplement 3Labeling | Approved | None posted |
| Sep 19, 2007 | 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
