TERAZOL 3 (nda019641)- (80MG)

Generic Name	TERCONAZOLE	Innovator	JANSSEN PHARMS
Dosage	80MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2001-Nov-09	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

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
80MG	**	**	-	2	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of TERAZOL 3