GIAPREZA (nda209360)- (EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML),EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML),EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML))

Generic Name	ANGIOTENSIN II ACETATE	Innovator	LA JOLLA PHARMA
Dosage	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML),EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML),EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2037-Jan-06	NCE Excl Expiry	2022-Dec-21
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	**	**	-	-	-
EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	**	**	-	-	-
EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of GIAPREZA