CEFAZOLIN IN DEXTROSE (nda207131)- (EQ 2GM BASE/100ML (EQ 20MG BASE/ML),EQ 1GM BASE/50ML (EQ 20MG BASE/ML))

Generic Name	CEFAZOLIN SODIUM	Innovator	BAXTER HLTHCARE CORP
Dosage	EQ 2GM BASE/100ML (EQ 20MG BASE/ML),EQ 1GM BASE/50ML (EQ 20MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Cefazolin 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
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 2GM BASE/100ML (EQ 20MG BASE/ML)	**	**	-	-	-
EQ 1GM BASE/50ML (EQ 20MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of CEFAZOLIN IN DEXTROSE