Last Updated: May 3, 2026

Details for New Drug Application (NDA): 219603

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NDA 219603 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, Somerset Theraps Llc, 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, Carlsbad, Chartwell Rx, Dr Reddys Labs Ltd, Glenmark Pharms, Graviti Pharms, Ivax Sub Teva Pharms, Mankind Pharma, Marksans 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-two NDAs. It is available from one hundred and thirty-three 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-seven suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for 219603

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

Medical Subject Heading (MeSH) Categories for 219603

Anti-Ulcer Agents
Histamine H2 Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	40MG/5ML
Approval Date:	Mar 9, 2026	TE:	AB	RLD:	No

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