PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER (nda020249)- (0.4MG/ML)

Generic Name	FAMOTIDINE	Innovator	MERCK SHARP DOHME
Dosage	0.4MG/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2001-Apr-15	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PEPCID is indicated in: 1. Short-term treatment of active duodenal ulcer. 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer. 3. Short-term treatment of active benign gastric ulcer. 4. Short-term treatment of gastroesophageal reflux disease (GERD). PEPCID is also indicated for the short-term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy. 5. Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas).

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

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
0.4MG/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	1

Manufacturing Details of PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER