TYZAVAN (nda211962)- (EQ 500MG BASE/100ML (EQ 5MG BASE/ML),EQ 1GM BASE/200ML (EQ 5MG BASE/ML),EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML),EQ 2GM BASE/400ML (EQ 5MG BASE/ML),EQ 750MG BASE/150ML (EQ 5MG BASE/ML),EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML),EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML))

Generic Name	VANCOMYCIN HYDROCHLORIDE	Innovator	HIKMA
Dosage	EQ 500MG BASE/100ML (EQ 5MG BASE/ML),EQ 1GM BASE/200ML (EQ 5MG BASE/ML),EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML),EQ 2GM BASE/400ML (EQ 5MG BASE/ML),EQ 750MG BASE/150ML (EQ 5MG BASE/ML),EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML),EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2035-Nov-06	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: • Septicemia • Infective Endocarditis • Skin and Skin Structure Infections • Bone Infections • Lower Respiratory Tract Infections

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	8

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 500MG BASE/100ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 2GM BASE/400ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TYZAVAN