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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 075486


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NDA 075486 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 suppliers are listed for this compound. Additional details are available on the famotidine profile page.
Summary for 075486
Tradename:FAMOTIDINE PRESERVATIVE FREE
Applicant:Hikma
Ingredient:famotidine
Patents:0
Pharmacology for NDA: 075486
Mechanism of ActionHistamine H2 Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 075486
Anti-Ulcer Agents
Histamine H2 Antagonists
Suppliers and Packaging for NDA: 075486
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075486 ANDA Hikma Pharmaceuticals USA Inc. 0641-6022 0641-6022-25 25 VIAL in 1 CARTON (0641-6022-25) / 2 mL in 1 VIAL (0641-6022-01)
FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075486 ANDA Medical Purchasing Solutions, LLC 71872-7235 71872-7235-1 1 VIAL in 1 BAG (71872-7235-1) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Apr 16, 2001TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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