PEPCID AC (nda020325)- (10MG,20MG)

Generic Name	FAMOTIDINE	Innovator	KENVUE BRANDS
Dosage	10MG,20MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2016-Jun-29	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PEPCID is a histamine-2 (H2) receptor antagonist indicated: In adult and pediatric patients 40 kg and greater for the treatment of:  active duodenal ulcer (DU).  active gastric ulcer.  symptomatic nonerosive gastroesophageal reflux disease (GERD).  erosive esophagitis due to GERD, diagnosed by biopsy. In adults for the:  treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).  reduction of the risk of DU recurrence.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
15	0	11

Other Developers

Total Other Developers	4

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
10MG	**	**	-	-	4
20MG	**	**	-	4	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	5

Manufacturing Details of PEPCID AC