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Last Updated: April 17, 2024

Details for New Drug Application (NDA): 077367

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NDA 077367 describes FAMOTIDINE, which is a drug marketed by Ajanta Pharma Ltd, Akorn, Alkem Labs Ltd, Amneals Pharms, Annora Pharma, Carnegie, Cerovene Inc, Lupin Ltd, Micro Labs, Navinta Llc, Novel Labs Inc, Novitium Pharma, 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, Mylan, Mylan Pharms Inc, P And L, Perrigo R And D, Rising, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Vkt Pharma, Watson Labs, Epic Pharma Llc, Abbvie, and Baxter Hlthcare, and is included in eighty-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-three suppliers are listed for this compound. Additional details are available on the calcium carbonate; famotidine; magnesium hydroxide profile page.

Summary for 077367

Tradename:	FAMOTIDINE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	famotidine
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 077367

Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 077367

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 077367

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FAMOTIDINE	famotidine	TABLET;ORAL	077367	ANDA	Albertsons Companies	21130-022	21130-022-30	1 BOTTLE in 1 CARTON (21130-022-30) / 30 TABLET in 1 BOTTLE
FAMOTIDINE	famotidine	TABLET;ORAL	077367	ANDA	Albertsons Companies	21130-023	21130-023-25	1 BOTTLE in 1 CARTON (21130-023-25) / 25 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Sep 25, 2006	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	OTC	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Aug 17, 2001	TE:		RLD:	No

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