Manages hypertension. ANDA 40780, held by Aurobindo Pharma. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 40780 (Hydrochlorothiazide), held by Aurobindo Pharma, was first approved by FDA on Jul 20, 2007, with 3 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 |
|---|---|---|---|
| Jul 20, 2007 | Original application | Approved | None posted |
| Hydrochlorothiazide25MG · tablet;oral | Hydrochlorothiazide | Rx |
| Hydrochlorothiazide50MG · tablet;oral | Hydrochlorothiazide | Rx |
| Aug 20, 2020 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jan 22, 2014 | Supplement 9Labeling | Approved | None posted |
| Jan 19, 2012 | Supplement 12Labeling | Approved | None posted |
| Jul 20, 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
