SYNTHETIC CONJUGATED ESTROGENS A (nda021788)- (0.625MG/GM)

Generic Name	ESTROGENS, CONJUGATED SYNTHETIC A	Innovator	TEVA WOMENS
Dosage	0.625MG/GM
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2011-Nov-28
GAIN Expiry	None	Drug Complexity	No
Indication	Synthetic Conjugated Estrogens, A, Vaginal Cream is a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vaginal Dryness, a Symptom of Vulvar and Vaginal Atrophy, due to Menopause • 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	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.625MG/GM	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of SYNTHETIC CONJUGATED ESTROGENS A