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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 091020

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NDA 091020 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 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 091020

Tradename:	FAMOTIDINE
Applicant:	Navinta Llc
Ingredient:	famotidine
Patents:	0

Pharmacology for NDA: 091020

Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 091020

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 091020

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	091020	ANDA	Zydus Pharmaceuticals USA Inc.	68382-444	68382-444-05	50 mL in 1 BOTTLE, PLASTIC (68382-444-05)
FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	091020	ANDA	Navinta LLC	68475-400	68475-400-01	50 mL in 1 BOTTLE, PLASTIC (68475-400-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	40MG/5ML
Approval Date:	May 27, 2010	TE:	AB	RLD:	No

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