PRINCIPEN '500 (NDA050056)- (EQ 500MG BASE)

Generic Name	AMPICILLIN/AMPICILLIN TRIHYDRATE	Innovator	APOTHECON
Dosage	EQ 500MG BASE
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	Ampicillin capsules and ampicillin for oral suspension are indicated in the treatment of infections caused by susceptible strains of the designated organisms listed below: *Infections of the genitourinary tract including gonorrhea:E. coli, P. mirabilis, enterococci, Shigella, S. typhosa and other Salmonella, and nonpenicillinase producing N. gonorrhoeae. *Infections of the respiratory tract: Nonpenicillinase- producing H. influenzae and staphylococci, and streptococci including streptococcus pneumoniae. *Infections of the gastrointestinal tract:Shigella, S. typhosa and other Salmonella, E. coli, P. mirabilis, and enterococci. *Meningitis:N. Meningitides.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	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
EQ 500MG BASE	**	**	-	-	2

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	2

Manufacturing Details of PRINCIPEN '500