PROZAC (nda018936)- (EQ 20MG BASE,EQ 40MG BASE,EQ 60MG BASE,EQ 10MG BASE)

Generic Name	FLUOXETINE HYDROCHLORIDE	Innovator	ELI LILLY AND CO
Dosage	EQ 20MG BASE,EQ 40MG BASE,EQ 60MG BASE,EQ 10MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2017-Nov-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Prozac is indicated for the treatment of major depressive disorder.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
14	0	9

Other Developers

Total Other Developers	7

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 20MG BASE	**	**	Up	6	1
EQ 40MG BASE	**	**	Up	6	1
EQ 60MG BASE	**	**	-	-	-
EQ 10MG BASE	**	**	-	-	7

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	7

Manufacturing Details of PROZAC