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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Julphar
Dow
McKesson
Teva
US Army
Healthtrust
Express Scripts
Mallinckrodt

Generated: May 21, 2018

DrugPatentWatch Database Preview

Drug Master Files for: DEXTROSE; SODIUM CHLORIDE

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DEXTROSE; SODIUM CHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
4697 A II 10/27/1982 ROQUETTE FRERES DEXTROSE MONOHYDRATE USP GRADE (LYCADEX? PF)
11059 A II 9/1/1994 ROQUETTE AMERICA INC DEXTROSE MONOHYDRATE, USP GRADE
14294 A II 6/30/1999 INGREDION INC ANHYDROUS DEXTROSE USP
26449 I II 9/7/2012 XIWANG PHARMACEUTICAL CO LTD DEXTROSE MONOHYDRATE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

Harvard Business School
Queensland Health
McKinsey
Accenture
McKesson
Baxter
US Army
Mallinckrodt
Merck

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