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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Argus Health
Novartis
Fish and Richardson
Medtronic
Healthtrust
Federal Trade Commission
US Department of Justice
Colorcon
Boehringer Ingelheim

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206530

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NDA 206530 describes FAMOTIDINE, which is a drug marketed by Hi-tech Pharma Co, Lupin Ltd, Navinta Llc, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, West-ward Pharms Int, Novel Labs Inc, Perrigo, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Carlsbad, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Perrigo R And D, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Abbvie, and Baxter Hlthcare, and is included in sixty-one NDAs. It is available from one hundred and sixteen 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 seventy-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 206530
Tradename:FAMOTIDINE
Applicant:Aurobindo Pharma Ltd
Ingredient:famotidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 206530
Medical Subject Heading (MeSH) Categories for 206530
Suppliers and Packaging for NDA: 206530
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE famotidine TABLET;ORAL 206530 ANDA Clinical Solutions Wholesale, LLC 58118-0859 58118-0859-8 30 TABLET, FILM COATED in 1 BLISTER PACK (58118-0859-8)
FAMOTIDINE famotidine TABLET;ORAL 206530 ANDA Aurobindo Pharma Limited 65862-859 65862-859-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-859-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Dec 22, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Dec 22, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Dow
Covington
Boehringer Ingelheim
Medtronic
US Department of Justice
Fuji
Harvard Business School
Cipla

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