CEFEPIME IN PLASTIC CONTAINER (nda050817)- (EQ 1GM BASE/50ML (EQ 20MG BASE/ML),EQ 2GM BASE/100ML (EQ 20MG BASE/ML))

Generic Name	CEFEPIME HYDROCHLORIDE	Innovator	BAXTER HLTHCARE
Dosage	EQ 1GM BASE/50ML (EQ 20MG BASE/ML),EQ 2GM BASE/100ML (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	Cefepime Injection is a cephalosporin antibacterial indicated in the treatment of the following infections caused by susceptible isolates of the designated microorganisms: pneumonia; empiric therapy for febrile neutropenic patients; uncomplicated and complicated urinary tract infections; uncomplicated skin and skin structure infections; and complicated intra-abdominal infections (used in combination with metronidazole).

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 1GM BASE/50ML (EQ 20MG BASE/ML)	**	**	-	-	-
EQ 2GM BASE/100ML (EQ 20MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of CEFEPIME IN PLASTIC CONTAINER