ENJUVIA (nda021443)- (0.3MG,0.45MG,0.625MG,0.9MG,1.25MG)

Generic Name	ESTROGENS, CONJUGATED SYNTHETIC B	Innovator	ASPEN
Dosage	0.3MG,0.45MG,0.625MG,0.9MG,1.25MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2021-Mar-08	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ENJUVIA (synthetic conjugated estrogens, B) is a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause. • Treatment of Moderate to Severe Vaginal Dryness and Pain with Intercourse, Symptoms 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	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.3MG	**	**	-	-	-
0.45MG	**	**	-	-	-
0.625MG	**	**	-	-	-
0.9MG	**	**	-	-	-
1.25MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ENJUVIA