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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 075457

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NDA 075457 describes FAMOTIDINE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Annora Pharma, Appco, Aurobindo Pharma Ltd, Bionpharma, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Micro Labs, MSN, Navinta Llc, Novel Labs Inc, Novitium Pharma, Pharmobedient, Unichem, Apotex Inc, Apothecon, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, Sagent, Zydus Pharms, Perrigo, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Beximco Pharms Usa, Carlsbad, Chartwell Rx, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans Pharma, Mylan Pharms Inc, Natco Pharma, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Abbvie, and Baxter Hlthcare, and is included in ninety-one NDAs. It is available from one hundred and thirty-four suppliers. Additional details are available on the FAMOTIDINE profile page.

The generic ingredient in FAMOTIDINE is calcium carbonate; famotidine; magnesium hydroxide. There are two hundred and eighty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for 075457

Tradename:	FAMOTIDINE
Applicant:	Mylan Pharms Inc
Ingredient:	famotidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 075457

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Apr 18, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Apr 18, 2001	TE:		RLD:	No

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