Manages hypertension. ANDA 40907, held by Unichem. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 40907 (Hydrochlorothiazide), held by Unichem, was first approved by FDA on Aug 15, 2008, with 3 approved supplements and 0 published complete response letters.
Hydrochlorothiazide tablets are indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Hydrochlorothiazide tablets 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 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 |
|---|---|---|---|
| Aug 15, 2008 | Original application | Approved | None posted |
| Hydrochlorothiazide25MG · tablet;oral | Hydrochlorothiazide | Rx |
| Hydrochlorothiazide50MG · tablet;oral | Hydrochlorothiazide | Rx |
| Hydrochlorothiazide12.5MG · tablet;oral | Hydrochlorothiazide | Rx |
| Aug 20, 2020 | Supplement 18Labeling · Standard review | Approved | None posted |
| Mar 7, 2016 | Supplement 9Manufacturing | Approved | None posted |
| Nov 14, 2011 | Supplement 4Labeling | Approved | None posted |
| Aug 15, 2008 | 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
