IMVEXXY (nda208564)- (0.004MG,0.01MG)

Generic Name	ESTRADIOL	Innovator	MAYNE PHARMA
Dosage	0.004MG,0.01MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2034-Feb-02	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2021-May-29
GAIN Expiry	None	Drug Complexity	No
Indication	IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

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
0.004MG	**	**	Up	-	-
0.01MG	**	**	Up	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of IMVEXXY