DROSPIRENONE (nda216285)- (3.5MG)

Generic Name	DROSPIRENONE	Innovator	EXELTIS USA INC
Dosage	3.5MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2031-Jun-28	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2025-Jun-29
GAIN Expiry	None	Drug Complexity	No
Indication	Drospirenone Chewable Tablets is a progestin indicated for use by females of reproductive potential to prevent pregnancy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
3.5MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of DROSPIRENONE