Manages hypertension. ANDA 40702, held by Leading. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 40702 (Hydrochlorothiazide), held by Leading, was first approved by FDA on Mar 16, 2007, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrochlorothiazide tablets USP are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets USP have 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 USP 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 |
|---|---|---|---|
| Mar 16, 2007 | Original application | Approved | None posted |
| Hydrochlorothiazide25MG · tablet;oral | Hydrochlorothiazide | Rx |
| Hydrochlorothiazide50MG · tablet;oral | Hydrochlorothiazide | Rx |
| Hydrochlorothiazide12.5MG · tablet;oral | Hydrochlorothiazide | Rx |
| Oct 6, 2023 | Supplement 14Labeling · Standard review | Approved | None posted |
| Aug 20, 2020 | Supplement 12Labeling · Standard review | Approved | None posted |
| Oct 22, 2014 | Supplement 6Manufacturing | Approved | None posted |
| May 1, 2008 | Supplement 3Labeling | Approved | None posted |
| Mar 16, 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
