CARDURA (nda019668)- (EQ 1MG BASE,EQ 2MG BASE,EQ 4MG BASE,EQ 8MG BASE)

Generic Name	DOXAZOSIN MESYLATE	Innovator	VIATRIS
Dosage	EQ 1MG BASE,EQ 2MG BASE,EQ 4MG BASE,EQ 8MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2000-Oct-18	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CARDURA is an alpha1 adrenergic antagonist indicated for:  Signs and symptoms of Benign Prostatic Hyperplasia (BPH)  Treatment of Hypertension

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	8

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1MG BASE	**	**	-	-	7
EQ 2MG BASE	**	**	-	6	1
EQ 4MG BASE	**	**	-	-	7
EQ 8MG BASE	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	6

Manufacturing Details of CARDURA