Manages hypertension. ANDA 40707, held by Actavis Elizabeth. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 40707 (Hydrochlorothiazide), held by Actavis Elizabeth, was first approved by FDA on Feb 27, 2007, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrochlorothiazide12.5MG · tablet;oral | Hydrochlorothiazide | Rx |
| Aug 20, 2020 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 16, 2007 | Supplement 1Manufacturing | Approved | None posted |
| Feb 27, 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
