COMBOGESIC IV (NDA215320)- (1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML))

Generic Name	ACETAMINOPHEN; IBUPROFEN SODIUM	Innovator	HIKMA
Dosage	1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2036-Jan-14	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2026-Oct-17
GAIN Expiry	None	Drug Complexity	No
Indication	COMBOGESIC IV is indicated in adults where an intravenous route of administration is considered clinically necessary for • the relief of mild to moderate pain • the management of moderate to severe pain as an adjunct to opioid analgesics .

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
1GM/100ML (10MG/ML);EQ 300MG BASE/100ML (EQ 3MG BASE/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of COMBOGESIC IV