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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 075813


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NDA 075813 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 075813
Tradename:FAMOTIDINE PRESERVATIVE FREE
Applicant:Fresenius Kabi Usa
Ingredient:famotidine
Patents:0
Pharmacology for NDA: 075813
Mechanism of ActionHistamine H2 Receptor Antagonists
Medical Subject Heading (MeSH) Categories for 075813
Anti-Ulcer Agents
Histamine H2 Antagonists
Suppliers and Packaging for NDA: 075813
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075813 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1375 51662-1375-1 2 mL in 1 VIAL, SINGLE-DOSE (51662-1375-1)
FAMOTIDINE PRESERVATIVE FREE famotidine INJECTABLE;INJECTION 075813 ANDA HF Acquisition Co LLC, DBA HealthFirst 51662-1375 51662-1375-2 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1375-2) / 2 mL in 1 VIAL, SINGLE-DOSE

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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