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Last Updated: November 7, 2024

Drug Master Files for: lactulose


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lactulose Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10145 A II 3/19/1993 CANLAC GROUP ABBOTT LABORATORIES LTD LACTULOSE CONCENTRATE USP
11262 I II 12/25/1994 INALCO SPA LACTULOSE CRYSTALS
11448 I II 4/11/1995 SOLVAY DUPHAR BV LACTULOSE CONCENTRATE
12699 I II 10/14/1997 SOLVAY DUPHAR BV LACTULOSE CRYSTALLINE
15253 A II 2/16/2001 FRESENIUS KABI AUSTRIA GMBH LACTULOSE SOLUTION USP
15254 A II 2/16/2001 FRESENIUS KABI AUSTRIA GMBH LACTULOSE CRYSTALS
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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