Last Updated: June 24, 2026

Details for New Drug Application (NDA): 075825

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NDA 075825 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 075825

Tradename:	FAMOTIDINE PRESERVATIVE FREE
Applicant:	Sagent
Ingredient:	famotidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 075825

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Apr 17, 2001	TE:	AP	RLD:	No

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