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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 215822

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NDA 215822 describes FAMOTIDINE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Annora Pharma, Aurobindo Pharma Ltd, Bionpharma, Epic Pharma Llc, Lannett Co Inc, Lupin Ltd, Micro Labs, MSN, Navinta Llc, Novel Labs Inc, Novitium Pharma, Pharmobedient, 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, 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, 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-one NDAs. It is available from one hundred and thirty-one 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-six suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for 215822

Tradename:	FAMOTIDINE
Applicant:	Vkt Pharma
Ingredient:	famotidine
Patents:	0

Pharmacology for NDA: 215822

Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 215822

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 215822

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FAMOTIDINE	famotidine	TABLET;ORAL	215822	ANDA	SAFEWAY	21130-191	21130-191-20	200 TABLET in 1 BOTTLE (21130-191-20)
FAMOTIDINE	famotidine	TABLET;ORAL	215822	ANDA	Bi-Mart	37835-161	37835-161-50	50 TABLET in 1 BOTTLE (37835-161-50)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jan 28, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jan 28, 2022	TE:		RLD:	No

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