For significant cardiac arrhythmias. ANDA 79133, held by Sigmapharm Labs LLC. Amiloride Hydrochloride.
As of Nov 15, 2026, ANDA 79133 (Amiloride Hydrochloride), held by Sigmapharm Labs LLC, was first approved by FDA on Jan 30, 2009, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Amiloride HCl tablets are indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to: a. help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic b. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 30, 2009 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Amiloride Hydrochloride5MG · tablet;oral | Amiloride Hydrochloride | 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
