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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Moodys
Argus Health
Accenture
Fish and Richardson
Express Scripts
Medtronic
QuintilesIMS
McKesson

Generated: May 27, 2018

DrugPatentWatch Database Preview

Drug Master Files for: ESOMEPRAZOLE SODIUM

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ESOMEPRAZOLE SODIUM Drug Master Files

DMF No. Status Type Submission Date Holder Subject
29974 A II 11/28/2016 STERILE INDIA PVT LTD ESOMEPRAZOLE SODIUM (STERILE)
17278 I II 3/31/2004 DR REDDYS LABORATORIES LTD ESOMEPRAZOLE MAGNESIUM
18559 I II 8/3/2005 SUN PHARMACEUTICAL INDUSTRIES LTD ESOMEPRAZOLE MAGNESIUM (AMORPHOUS, NON-STERILE BULK DRUG SUBSTANCE)
18821 A II 9/28/2005 CIPLA LTD ESOMEPRAZOLE MAGNESIUM DIHYDRATE USP
DMF No. Status Type Submission Date Holder Subject

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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Covington
Moodys
Julphar
Accenture
McKesson
Merck
Mallinckrodt
Federal Trade Commission

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