Details for New Drug Application (NDA): 071851

NDA 071851 describes TRIAMTERENE AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Ani Pharms, Cadila, Chartwell Rx, Duramed Pharms Barr, Lannett Co Inc, Norvium Bioscience, Novartis, Sandoz, Vitarine, Am Therap, Apotex Inc, Pliva, Quantum Pharmics, Rubicon, Watson Labs, and Zydus Pharms, and is included in twenty-two NDAs. It is available from twenty-nine suppliers. Additional details are available on the TRIAMTERENE AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in TRIAMTERENE AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; triamterene. There are thirty-two drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.

Summary for 071851

Tradename:	TRIAMTERENE AND HYDROCHLOROTHIAZIDE
Applicant:	Watson Labs
Ingredient:	hydrochlorothiazide; triamterene
Patents:	0

Pharmacology for NDA: 071851

Physiological Effect

Decreased Renal K+ Excretion Increased Diuresis

Suppliers and Packaging for NDA: 071851

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	071851	ANDA	Actavis Pharma, Inc.	0591-0348	0591-0348-01	100 TABLET in 1 BOTTLE, PLASTIC (0591-0348-01)
TRIAMTERENE AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; triamterene	TABLET;ORAL	071851	ANDA	Actavis Pharma, Inc.	0591-0348	0591-0348-05	500 TABLET in 1 BOTTLE, PLASTIC (0591-0348-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	50MG;75MG
Approval Date:	Nov 30, 1988	TE:	AB	RLD:	No

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