COLAZAL (nda020610)- (750MG)

Generic Name	BALSALAZIDE DISODIUM	Innovator	VALEANT PHARMS INTL
Dosage	750MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2027-Feb-24	NCE Excl Expiry	Expired
ODE Expiry	2013-Dec-20	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	COLAZAL is an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	0	3

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
750MG	**	**	-	-	3

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of COLAZAL