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Last Updated: April 20, 2024

Drug Master Files for: Esi


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Esi Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10026 I II 12/30/1992 GENESIS INDUSTRIES INC MANUFACTURING FACILITY IN ELMWOOD, WISCONSIN
10045 I II 1/13/1993 NORDIC SYNTHESIS AB KETOPROFEN
10214 I II 4/8/1993 LANCASTER SYNTHESIS DIV MTM RESEARCH CHEMICALS LTD FACILITIES AND PROCEDURES IN LANCASTER, ENGLAND
10215 I II 4/8/1993 LANCASTER SYNTHESIS DIV MTM RESEARCH CHEMICALS LTD METHYLENE DIPHOSPHONIC ACID
10486 I III 9/15/1993 SWIFT ADHESIVES DIV REICHHOLD CHEMICALS INC SWIFT 2H041 ADHESIVE
10647 I II 10/28/1993 ADHESIVES RESEARCH INC PRESSURE SENSITIVE ADHESIVES USED AS DRUG MATRIXES
10819 I III 3/10/1994 MORGAN ADHESIVES CO ROLL PRODUCTS DIV PHARMACEUTICAL LABEL PRODUCT LINE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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