Treats salt and water retention. ANDA 213251, held by Alembic. Metolazone.
As of Nov 15, 2026, ANDA 213251 (Metolazone), held by Alembic, was first approved by FDA on Dec 2, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Metolazone tablets are indicated for the treatment of salt and water retention including: edema accompanying congestive heart failure; edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. Metolazone tablets are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class. MYKROX Tablets, a more rapidly available form of metolazone, are intended for the treatment of new patients with mild to moderate hypertension.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 2, 2020 | Original application | Approved | None posted |
| Metolazone2.5MG · tablet;oral | Metolazone | Rx |
| Metolazone5MG · tablet;oral | Metolazone | Rx |
| Metolazone10MG · tablet;oral | Metolazone | 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
