You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 31, 2025

Details for New Drug Application (NDA): 201695

✉ Email this page to a colleague

« Back to Dashboard

NDA 201695 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-five 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 201695

Tradename:	FAMOTIDINE
Applicant:	Novel Labs Inc
Ingredient:	famotidine
Patents:	0

Pharmacology for NDA: 201695

Mechanism of Action	Histamine H2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 201695

Anti-Ulcer Agents
Histamine H2 Antagonists

Suppliers and Packaging for NDA: 201695

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FAMOTIDINE	famotidine	FOR SUSPENSION;ORAL	201695	ANDA	Lupin Pharmaceuticals,Inc.	43386-500	43386-500-11	50 mL in 1 BOTTLE (43386-500-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	40MG/5ML
Approval Date:	Dec 17, 2012	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.