GIAZO (nda022205)- (1.1GM)

Generic Name	BALSALAZIDE DISODIUM	Innovator	VALEANT PHARMS INTL
Dosage	1.1GM
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2031-Jun-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	GIAZO is an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	2	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1.1GM	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of GIAZO