SEASONIQUE (nda021840)- (0.03MG,0.01MG;0.15MG,N/A)

Generic Name	ETHINYL ESTRADIOL; LEVONORGESTREL	Innovator	TEVA BRANDED PHARM
Dosage	0.03MG,0.01MG;0.15MG,N/A
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2028-Dec-05	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	is an estrogen/progestin COC indicated for use by women to prevent pregnancy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
7	1	6

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.03MG,0.01MG;0.15MG,N/A	**	**	-	-	6

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	6

Manufacturing Details of SEASONIQUE