Last Updated: November 8, 2026

Details for New Drug Application (NDA): 076101

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NDA 076101 describes FAMOTIDINE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma Ltd, Bionpharma, Carnegie, Contract Pharmacal, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Micro Labs, MSN, Navinta Llc, Novel Labs Inc, Novitium Pharma, Pharmazone, Somerset Theraps Llc, Apotex Inc, Apothecon, Fresenius Kabi Usa, Hikma, Hospira, Lupin, Mylan Labs Ltd, Sagent, Zydus Pharms, Perrigo, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Ascent Pharms Inc, Aurobindo Pharma, Carlsbad, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Mylan Pharms Inc, Natco Pharma, P And L, Perrigo R And D, Regcon Holdings, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Abbvie, and Baxter Hlthcare, and is included in ninety-three NDAs. It is available from one hundred and forty-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 drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for 076101

Tradename:	FAMOTIDINE
Applicant:	Sandoz
Ingredient:	famotidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 076101

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 21, 2002	TE:		RLD:	No

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