Manages hypertension. ANDA 40412, held by Prinston. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 40412 (Hydrochlorothiazide), held by Prinston, was first approved by FDA on Mar 29, 2002, 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 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 |
|---|---|---|---|
| Mar 29, 2002 | Original application | Approved |
| Hydrochlorothiazide25MG · tablet;oral | Hydrochlorothiazide | Discontinued |
| Hydrochlorothiazide50MG · tablet;oral | Hydrochlorothiazide | Discontinued |
| Aug 20, 2020 | Supplement 23Labeling · Standard review | Approved | None posted |
| Dec 31, 2011 | Supplement 11Labeling | Approved | None posted |
| Mar 29, 2002 | Original application | Approved |
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
