CHILDREN'S ADVIL COLD (nda021373)- (100MG/5ML;15MG/5ML)

Generic Name	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	Innovator	HALEON US HOLDINGS
Dosage	100MG/5ML;15MG/5ML
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CHILDREN'S ADVIL COLD is indicated for treating cold, sinus and flue symptoms temporarily.

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
100MG/5ML;15MG/5ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of CHILDREN'S ADVIL COLD