ANCEF (nda050461)- (EQ 250MG BASE/VIAL,EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL,EQ 5GM BASE/VIAL,EQ 10GM BASE/VIAL)

Generic Name	CEFAZOLIN SODIUM	Innovator	GLAXOSMITHKLINE
Dosage	EQ 250MG BASE/VIAL,EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL,EQ 5GM BASE/VIAL,EQ 10GM 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	ANCEF (Cefazolin Sodium) injection is a cephalosporin antibacterial indicated for: • Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved: ο Respiratory tract infections ο Urinary tract infections ο Skin and skin structure infections ο Biliary tract infections ο Bone and joint infections ο Genital infections ο Septicemia ο Endocarditis • Perioperative prophylaxis in adults for whom appropriate dosing with this formulation can be achieved.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	8

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	Yes

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 250MG BASE/VIAL	**	**	-	-	-
EQ 500MG BASE/VIAL	**	**	-	-	-
EQ 1GM BASE/VIAL	**	**	-	-	4
EQ 5GM BASE/VIAL	**	**	-	-	-
EQ 10GM BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	8

Manufacturing Details of ANCEF