MAXZIDE-25 (nda019129)- (25MG;37.5MG)

Generic Name	HYDROCHLOROTHIAZIDE; TRIAMTERENE	Innovator	AUROBINDO PHARMA USA
Dosage	25MG;37.5MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2002-Jul-27	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	1. MAXZIDE (triamterene and hydrochlorothiazide) is indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. 2. MAXZIDE is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arrhythmias, etc.). MAXZIDE may be used alone or in combination with other antihypertensive drugs, such as beta-blockers. Since MAXZIDE (triamterene and hydrochlorothiazide) may enhance the actions of these drugs, dosage adjustments may be necessary.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
5	0	4

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
25MG;37.5MG	**	**	-	4	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of MAXZIDE-25