PENICILLIN G POTASSIUM IN PLASTIC CONTAINER (nda050638)- (20,000 UNITS/ML,40,000 UNITS/ML,60,000 UNITS/ML)

Generic Name	PENICILLIN G POTASSIUM	Innovator	BAXTER HLTHCARE
Dosage	20,000 UNITS/ML,40,000 UNITS/ML,60,000 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	Penicillin G Potassium Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis Anthrax, Actinomycosis (cervico-facial disease and thoracic and abdominal disease), Botulism (adjunctive therapy to antitoxin), gas gangrene, and tetanus (adjunctive therapy to human tetanus immune globulin), Diphtheria (adjunctive therapy to antitoxin and prevention of the carrier state), Erysipelothrix endocarditis, Fusospirochetosis (severe infections of the oropharynx [Vincent’s], lower respiratory tract and genital area), Listeria infections including meningitis and endocarditis, Pasteurella infections including bacteremia and meningitis, Haverhill fever, Rat bite fever, Disseminated gonococcal infections, Syphilis (congenital and neurosyphilis), Meningococcal meningitis and/or septicemia, Gram-negative bacillary infections (bacteremias).

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
20,000 UNITS/ML	**	**	-	-	-
40,000 UNITS/ML	**	**	-	-	-
60,000 UNITS/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of PENICILLIN G POTASSIUM IN PLASTIC CONTAINER