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Generated: June 26, 2019

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Drug Master Files for: DEXTROSE

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DEXTROSE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
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
26450 I II 9/7/2012 XIWANG PHARMACEUTICAL CO LTD DEXTROSE ANHYDROUS
28710 A IV 10/3/2014 SD FINE CHEM LTD DEXTROSE ANHYDROUS USP
30079 A II 11/23/2015 WEIFANG SHENGTAI MEDICINE CO LTD DEXTROSE MONOHYDRATE
30087 A II 11/23/2015 WEIFANG SHENGTAI MEDICINE CO LTD DEXTROSE ANHYDROUS
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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