POTASSIUM PHOSPHATES (nda212121)- (4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML))

Generic Name	POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC	Innovator	CMP DEV LLC
Dosage	4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2039-Apr-19	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	POTASSIUM PHOSPHATES INJECTION is a phosphorus replacement product indicated as a source of phosphorus: ● in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated. ● for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	11

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
4.5GM/15ML (300MG/ML);2.65GM/15ML (175MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of POTASSIUM PHOSPHATES