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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
US Department of Justice
Covington
Johnson and Johnson
Mallinckrodt
Colorcon
Fish and Richardson
McKinsey
Express Scripts

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090837

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NDA 090837 describes FAMOTIDINE, which is a drug marketed by Hi-tech Pharma Co, Lupin Ltd, Navinta Llc, Novel Labs Inc, Apotex Inc, Apothecon, Athenex Inc, Fresenius Kabi Usa, Hospira, Mylan Labs Ltd, West-ward Pharms Int, 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, Pld Acquisitions, Sandoz, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Watson Labs, Wockhardt, Wockhardt Ltd, Abbvie, and Baxter Hlthcare, and is included in sixty-one NDAs. It is available from one hundred and twelve 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-five 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 090837
Tradename:FAMOTIDINE
Applicant:Wockhardt
Ingredient:famotidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 090837
Suppliers and Packaging for NDA: 090837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FAMOTIDINE famotidine TABLET;ORAL 090837 ANDA WOCKHARDT LIMITED 55648-374 E 55648-374-00
FAMOTIDINE famotidine TABLET;ORAL 090837 ANDA WOCKHARDT LIMITED 55648-374 E 55648-374-01

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength20MG
Approval Date:Aug 4, 2010TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School
Cipla
US Army
Farmers Insurance
Johnson and Johnson
Healthtrust
Julphar
Chubb

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