Last Updated: June 24, 2026

Details for New Drug Application (NDA): 078642


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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 seven 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-two 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 ActionHistamine 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:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jun 25, 2008TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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