APRESOLINE (nda008303)- (20MG/ML)

Generic Name	HYDRALAZINE HYDROCHLORIDE	Innovator	NOVARTIS
Dosage	20MG/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	APRESOLINE is indicated for essential hypertension, alone or as an adjunct.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	7

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
20MG/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	7

Manufacturing Details of APRESOLINE