NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE (nda022573)- (0.025MG;0.8MG)

Generic Name	ETHINYL ESTRADIOL; NORETHINDRONE	Innovator	TEVA BRANDED PHARM
Dosage	0.025MG;0.8MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2019-Apr-06	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2013-Dec-22
GAIN Expiry	None	Drug Complexity	No
Indication	GENERESS Fe is an estrogen/progestin COC indicated for use by women to prevent pregnancy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

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
0.025MG;0.8MG	**	**	-	2	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE