MIRALAX (nda020698)- (17GM/SCOOPFUL)

Generic Name	POLYETHYLENE GLYCOL 3350	Innovator	BRAINTREE
Dosage	17GM/SCOOPFUL
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2019-Apr-20	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	MIRALAX is indicated for: • relieves occasional constipation (irregularity) • generally produces a bowel movement in 1 to 3 days

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
17GM/SCOOPFUL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of MIRALAX