CASPORYN HC (nda060613)- (1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML)

Generic Name	HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	Innovator	CASPER PHARMA LLC
Dosage	1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
3	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
1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML	**	**	-	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of CASPORYN HC