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Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204354

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NDA 204354 describes MESALAMINE, which is a drug marketed by G And W Labs Inc, Perrigo Israel, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in five NDAs. It is available from three suppliers. Additional details are available on the MESALAMINE profile page.

The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 204354
Tradename:MESALAMINE
Applicant:Mylan Pharms Inc
Ingredient:mesalamine
Patents:0
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 204354

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength1GM
Approval Date:Nov 24, 2015TE:ABRLD:No

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