Manages hypertension. ANDA 218248, held by Rubicon Research. Hydrochlorothiazide.
As of Nov 15, 2026, ANDA 218248 (Hydrochlorothiazide), held by Rubicon Research, was first approved by FDA on Oct 7, 2026, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Hydrochlorothiazide solution is 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 glomeru-lonephritis, and chronic renal failure. Hydrochlorothiazide is 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 |
|---|---|---|---|
| Oct 7, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydrochlorothiazide50MG/5ML · solution;oral | Hydrochlorothiazide | Rx |
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
