SEASONALE (nda021544)- (0.03MG;0.15MG)

Generic Name	ETHINYL ESTRADIOL; LEVONORGESTREL	Innovator	TEVA BRANDED PHARM
Dosage	0.03MG;0.15MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2017-Jun-23	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	SEASONALE is an estrogen/progestin COC indicated for use by women to prevent pregnancy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
8	0	6

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
0.03MG;0.15MG	**	**	-	-	5

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	6

Manufacturing Details of SEASONALE