Amiloride Hydrochloride

For significant cardiac arrhythmias. ANDA 70346, held by Ph Health. Amiloride Hydrochloride.

As of Nov 15, 2026, ANDA 70346 (Amiloride Hydrochloride), held by Ph Health, was first approved by FDA on Jan 22, 1986, with 9 approved supplements and 0 published complete response letters.

First approved: Jan 22, 1986
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Jan 22, 1986	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Amiloride Hydrochloride5MG · tablet;oral	Amiloride Hydrochloride	Rx

All 10 submissions, including labeling and manufacturing supplements


Jun 18, 2004	Supplement 12Labeling	Approved	None posted
Sep 16, 2002	Supplement 11Labeling	Approved	None posted
Jun 7, 2001	Supplement 10Manufacturing	Approved	None posted
Nov 26, 1997	Supplement 8Manufacturing	Approved	None posted
Nov 26, 1997	Supplement 9Manufacturing	Approved	None posted
Oct 24, 1989	Supplement 7Labeling	Approved	None posted
May 19, 1989	Supplement 6Labeling	Approved	None posted
Oct 5, 1987	Supplement 4Manufacturing	Approved	None posted
May 16, 1986	Supplement 1Manufacturing	Approved	None posted
Jan 22, 1986	Original application	Approved	None posted

Identifiers

Application: ANDA 70346
Drugs@FDA: Overview at FDA
Company: PH Health

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