BALCOLTRA (nda208612)- (0.02MG;0.1MG)

Generic Name	ETHINYL ESTRADIOL; LEVONORGESTREL	Innovator	AVION PHARMS
Dosage	0.02MG;0.1MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2027-Jun-01	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Balcoltra 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
2	0	2

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.02MG;0.1MG	**	**	Up	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of BALCOLTRA