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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076383

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NDA 076383 describes NIZATIDINE, which is a drug marketed by Ani Pharms Inc, Apotex Inc, Dr Reddys Labs Ltd, Glenmark Generics, Mylan Pharms Inc, Sandoz, Watson Labs, and Amneal Pharms, and is included in ten NDAs. It is available from sixteen suppliers. Additional details are available on the NIZATIDINE profile page.

The generic ingredient in NIZATIDINE is nizatidine. There are seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the nizatidine profile page.
Summary for 076383
Tradename:NIZATIDINE
Applicant:Apotex Inc
Ingredient:nizatidine
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 076383

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength150MG
Approval Date:Jan 23, 2003TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength300MG
Approval Date:Jan 23, 2003TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Chubb
Healthtrust
AstraZeneca
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Cerilliant
Queensland Health
Accenture
US Army

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