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Last Updated: March 29, 2024

Drug Master Files for: Iomed


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Iomed Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11609 I II 7/25/1995 LIFECORE BIOMEDICAL INC HY-50 HYALURONATE SODIUM STERILE INJECTION
14514 I II 11/5/1999 PRONOVA BIOMEDICAL AS G SITE FACILITIES OPERATING PROCEDURES AND PERSONEL FOR OSLO NORWAY
15709 I II 11/8/2001 BIOMEDISYN CORP (-)-HUPERZINE A AS IMPORTED BY BIOMEDISYN IN WOODBRIDGE, CT
20980 I II 10/26/2007 LIFECORE BIOMEDICAL LLC ANIMAL COMPONENT FREE SODIUM HYALURONATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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