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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 204180

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NDA 204180 describes AMILORIDE HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Ph Health, Sigmapharm Labs Llc, Barr, Rising, Teva, and Watson Labs, and is included in eight NDAs. It is available from three suppliers. Additional details are available on the AMILORIDE HYDROCHLORIDE profile page.

The generic ingredient in AMILORIDE HYDROCHLORIDE is amiloride hydrochloride; hydrochlorothiazide. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.

Summary for 204180

Tradename:	AMILORIDE HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	amiloride hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 204180

Acid Sensing Ion Channel Blockers
Diuretics
Epithelial Sodium Channel Blockers

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 7, 2015	TE:		RLD:	No

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