BICILLIN C-R (nda050138)- (150,000 UNITS/ML;150,000 UNITS/ML,300,000 UNITS/ML;300,000 UNITS/ML)

Generic Name	PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE	Innovator	KING PHARMS LLC
Dosage	150,000 UNITS/ML;150,000 UNITS/ML,300,000 UNITS/ML;300,000 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	Bicillin C-R 900/300 is indicated in the treatment of infections as described below that are susceptible to serum levels characteristic of this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response. Bicillin C-R 900/300 is indicated in the treatment of the following in pediatric patients: Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci. Moderately severe pneumonia and otitis media due to susceptible Streptococcus pneumoniae.

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
150,000 UNITS/ML;150,000 UNITS/ML	**	**	-	-	-
300,000 UNITS/ML;300,000 UNITS/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of BICILLIN C-R