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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 218003

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NDA 218003 describes FAMOTIDINE, which is a drug marketed by Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, Unichem, Upsher Smith Labs, 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, Aurobindo Pharma Ltd, Carlsbad, Chartwell Rx, Contract Pharmacal, Dr Reddys Labs Ltd, Glenmark Pharms Inc, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans Pharma, MSN, 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, Torrent, Epic Pharma Llc, Abbvie, Baxter Hlthcare, and Endo Operations, and is included in eighty-six NDAs. It is available from one hundred and thirty-eight 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-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for 218003

Tradename:	FAMOTIDINE
Applicant:	Contract Pharmacal
Ingredient:	famotidine
Patents:	0

Medical Subject Heading (MeSH) Categories for 218003

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	May 28, 2024	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	May 28, 2024	TE:		RLD:	No

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