ZOSYN IN PLASTIC CONTAINER (nda050750)- (EQ 40MG BASE/ML;EQ 5MG BASE/ML,EQ 60MG BASE/ML;EQ 7.5MG BASE/ML,EQ 4GM BASE/100ML;EQ 500MG BASE/100ML)

Generic Name	PIPERACILLIN SODIUM; TAZOBACTAM SODIUM	Innovator	BAXTER HLTHCARE CORP
Dosage	EQ 40MG BASE/ML;EQ 5MG BASE/ML,EQ 60MG BASE/ML;EQ 7.5MG BASE/ML,EQ 4GM BASE/100ML;EQ 500MG BASE/100ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2023-Apr-14	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ZOSYN is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of:  Intra-abdominal infections in adult and pediatric patients 2 months of age and older  Nosocomial pneumonia in adult and pediatric patients 2 months of age and older  Skin and skin structure infections in adults  Female pelvic infections in adults  Community-acquired pneumonia in adults.

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 40MG BASE/ML;EQ 5MG BASE/ML	**	**	-	-	-
EQ 60MG BASE/ML;EQ 7.5MG BASE/ML	**	**	-	-	-
EQ 4GM BASE/100ML;EQ 500MG BASE/100ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ZOSYN IN PLASTIC CONTAINER