ALEVE PM (nda205352)- (25MG;220MG)

Generic Name	DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM	Innovator	BAYER HLTHCARE
Dosage	25MG;220MG
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	ALEVE PM is indicated • for relief of occasional sleeplessness when associated with minor aches and pains • helps you fall asleep and stay asleep

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
4	0	3

Other Developers

Total Other Developers	1

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
25MG;220MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ALEVE PM