ZAROXOLYN (nda017386)- (2.5MG,5MG,10MG)

Generic Name	METOLAZONE	Innovator	I3 PHARMS
Dosage	2.5MG,5MG,10MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZAROXOLYN tablets, USP, are indicated for the treatment of salt and water retention including: • edema accompanying congestive heart failure; • edema accompanying renal diseases, including the nephrotic syndrome and states of diminished renal function. ZAROXOLYN tablets, USP, are also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
11	0	9

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
2.5MG	**	**	-	-	7
5MG	**	**	-	-	7
10MG	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	8

Manufacturing Details of ZAROXOLYN