CARAC (nda020985)- (0.5%)

Generic Name	FLUOROURACIL	Innovator	EXTROVIS
Dosage	0.5%
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2021-Jun-02	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Carac is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
0.5%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of CARAC