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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Express Scripts
Deloitte
US Army
Healthtrust
Colorcon
QuintilesIMS
Chinese Patent Office
Teva

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201695

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NDA 201695 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 thirteen 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 201695
Tradename:FAMOTIDINE
Applicant:Novel Labs Inc
Ingredient:famotidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 201695
Medical Subject Heading (MeSH) Categories for 201695
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 Novel Laboratories, Inc. 40032-500 N 40032-500-11
FAMOTIDINE famotidine FOR SUSPENSION;ORAL 201695 ANDA Lupin Pharmaceuticals,Inc. 43386-500 N 43386-500-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength40MG/5ML
Approval Date:Dec 17, 2012TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Chinese Patent Office
Queensland Health
Fuji
Farmers Insurance
Healthtrust
Moodys
Merck

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