PEPCID COMPLETE (nda020958)- (800MG;10MG;165MG)

Generic Name	CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE	Innovator	KENVUE BRANDS
Dosage	800MG;10MG;165MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2022-Feb-26	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PEPCID COMPLETE is indicated to relieve heartburn associated with acid indigestion and sour stomach.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
800MG;10MG;165MG	**	**	-	1	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of PEPCID COMPLETE