FEMCON FE (nda021490)- (0.035MG;0.4MG)

Generic Name	ETHINYL ESTRADIOL; NORETHINDRONE	Innovator	APIL
Dosage	0.035MG;0.4MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2021-Jun-12	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	FEMCON Fe is a progestin/estrogen COC indicated for use by females of reproductive potential to prevent pregnancy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	5

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
0.035MG;0.4MG	**	**	-	2	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of FEMCON FE