CEFAZOLIN AND DEXTROSE (nda050779)- (EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL,EQ 2GM BASE/VIAL)

Generic Name	CEFAZOLIN SODIUM	Innovator	B BRAUN
Dosage	EQ 500MG BASE/VIAL,EQ 1GM BASE/VIAL,EQ 2GM BASE/VIAL
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 for Injection and Dextrose 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:  Respiratory tract infections;  Urinary tract infections;  Skin and skin structure infections;  Biliary tract infections;  Bone and joint infections;  Genital infections;  Septicemia;  Endocarditis;  Perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old 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 500MG BASE/VIAL	**	**	-	-	-
EQ 1GM BASE/VIAL	**	**	-	-	-
EQ 2GM BASE/VIAL	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of CEFAZOLIN AND DEXTROSE