TIMENTIN (nda050590)- (EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL,EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL,EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL)

Generic Name	CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM	Innovator	GLAXOSMITHKLINE
Dosage	EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL,EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL,EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL
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	TIMENTIN is a combination of a β-lactam antibacterial and a β-lactamase inhibitor indicated for the treatment of the following infections due to designated susceptible bacteria: • Septicemia • Lower respiratory infections • Bone and joint infections • Skin and skin structure infections • Urinary tract infections • Gynecologic infections • Intra-abdominal infections

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	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
EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL	**	**	-	-	-
EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL	**	**	-	-	-
EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of TIMENTIN