Details for New Drug Application (NDA): 071111

NDA 071111 describes AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Barr, Chartwell Rx, Rising, Teva, and Watson Labs, and is included in five NDAs. It is available from two suppliers. Additional details are available on the AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE 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 071111

Tradename:	AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
Applicant:	Barr
Ingredient:	amiloride hydrochloride; hydrochlorothiazide
Patents:	0

Pharmacology for NDA: 071111

Physiological Effect

Decreased Renal K+ Excretion Increased Diuresis

Suppliers and Packaging for NDA: 071111

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	071111	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0483	0555-0483-02	100 TABLET in 1 BOTTLE (0555-0483-02)
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	amiloride hydrochloride; hydrochlorothiazide	TABLET;ORAL	071111	ANDA	Teva Pharmaceuticals USA, Inc.	0555-0483	0555-0483-05	1000 TABLET in 1 BOTTLE (0555-0483-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 5MG ANHYDROUS;50MG
Approval Date:	May 10, 1988	TE:	AB	RLD:	No

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