SINEQUAN (nda016798)- (EQ 25MG BASE,EQ 50MG BASE,EQ 10MG BASE,EQ 100MG BASE,EQ 75MG BASE,EQ 150MG BASE)

Generic Name	DOXEPIN HYDROCHLORIDE	Innovator	PFIZER
Dosage	EQ 25MG BASE,EQ 50MG BASE,EQ 10MG BASE,EQ 100MG BASE,EQ 75MG BASE,EQ 150MG BASE
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	SINEQUAN is recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
25	0	21

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 25MG BASE	**	**	-	-	14
EQ 50MG BASE	**	**	-	-	14
EQ 10MG BASE	**	**	-	-	14
EQ 100MG BASE	**	**	-	-	14
EQ 75MG BASE	**	**	-	-	14
EQ 150MG BASE	**	**	-	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	18

Manufacturing Details of SINEQUAN