FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE (nda211039)- (0.4%;0.3%)

Generic Name	BENOXINATE HYDROCHLORIDE; FLUORESCEIN SODIUM	Innovator	BAUSCH LOMB IRELAND
Dosage	0.4%;0.3%
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2037-Nov-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a combination of fluorescein sodium, a disclosing agent and benoxinate hydrochloride, a local ester anesthetic indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic.

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
0.4%;0.3%	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of FLUORESCEIN SODIUM AND BENOXINATE HYDROCHLORIDE