Details for New Drug Application (NDA): 078642

NDA 078642 describes FAMOTIDINE PRESERVATIVE FREE, which is a drug marketed by Apothecon, Epic Pharma Llc, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Abbvie, and Baxter Hlthcare, and is included in twelve NDAs. It is available from six suppliers. Additional details are available on the FAMOTIDINE PRESERVATIVE FREE profile page.

The generic ingredient in FAMOTIDINE PRESERVATIVE FREE is famotidine. There are eighteen drug master file entries for this compound. One hundred and forty-four suppliers are listed for this compound. Additional details are available on the famotidine profile page.

Summary for 078642

Tradename:	FAMOTIDINE PRESERVATIVE FREE
Applicant:	Mylan Labs Ltd
Ingredient:	famotidine
Patents:	0

Pharmacology for NDA: 078642

Mechanism of Action

Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 078642

Anti-Ulcer Agents

Histamine H2 Antagonists

Suppliers and Packaging for NDA: 078642

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FAMOTIDINE PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	078642	ANDA	Mylan Institutional LLC	67457-433	67457-433-22	25 VIAL in 1 CARTON (67457-433-22) / 2 mL in 1 VIAL (67457-433-00)
FAMOTIDINE PRESERVATIVE FREE	famotidine	INJECTABLE;INJECTION	078642	ANDA	Medical Purchasing Solutions, LLC	71872-7220	71872-7220-1	1 VIAL in 1 BAG (71872-7220-1) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Jun 25, 2008	TE:	AP	RLD:	No

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