XACIATO (nda215650)- (EQ 2% BASE)

Generic Name	CLINDAMYCIN PHOSPHATE	Innovator	ORGANON LLC
Dosage	EQ 2% BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2036-Sep-22	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2024-Dec-07
GAIN Expiry	None	Drug Complexity	No
Indication	XACIATO is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older.

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
EQ 2% BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of XACIATO