VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER (nda050671)- (EQ 500MG BASE/100ML (EQ 5MG BASE/ML),EQ 750MG BASE/150ML (EQ 5MG BASE/ML),EQ 1GM BASE/200ML (EQ 5MG BASE/ML),EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML),EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML))

Generic Name	VANCOMYCIN HYDROCHLORIDE	Innovator	BAXTER HLTHCARE
Dosage	EQ 500MG BASE/100ML (EQ 5MG BASE/ML),EQ 750MG BASE/150ML (EQ 5MG BASE/ML),EQ 1GM BASE/200ML (EQ 5MG BASE/ML),EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML),EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER is a glycopeptide antibacterial indicated in adult and pediatric patients (less than 18 years of age) for the treatment of:  Clostridioides difficile-associated diarrhea  Enterocolitis caused by Staphylococcus aureus (including methicillinresistant strains).

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/100ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 750MG BASE/150ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 1GM BASE/200ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)	**	**	-	-	-
EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER