Details for New Drug Application (NDA): 070346

NDA 070346 describes AMILORIDE HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Endo Operations, 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. Two suppliers are listed for this compound. Additional details are available on the amiloride hydrochloride; hydrochlorothiazide profile page.

Summary for 070346

Tradename:	AMILORIDE HYDROCHLORIDE
Applicant:	Endo Operations
Ingredient:	amiloride hydrochloride
Patents:	0

Pharmacology for NDA: 070346

Physiological Effect

Decreased Renal K+ Excretion Increased Diuresis

Medical Subject Heading (MeSH) Categories for 070346

Acid Sensing Ion Channel Blockers

Diuretics

Epithelial Sodium Channel Blockers

Suppliers and Packaging for NDA: 070346

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	070346	ANDA	Par Pharmaceutical, Inc.	49884-117	49884-117-01	100 TABLET in 1 BOTTLE (49884-117-01)
AMILORIDE HYDROCHLORIDE	amiloride hydrochloride	TABLET;ORAL	070346	ANDA	Par Pharmaceutical, Inc.	49884-117	49884-117-10	1000 TABLET in 1 BOTTLE (49884-117-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 22, 1986	TE:	AB	RLD:	No

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