CILOXAN (nda019992)- (EQ 0.3% BASE)

Generic Name	CIPROFLOXACIN HYDROCHLORIDE	Innovator	SANDOZ
Dosage	EQ 0.3% BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2004-Jun-09	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CILOXAN Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus (Viridans Group), Conjunctivitis: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	5

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 0.3% BASE	**	**	-	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	3

Manufacturing Details of CILOXAN