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Last Updated: March 29, 2024

Drug Master Files for: Miles


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Miles Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10108 I IV 2/16/1993 MILES INC LEWATIT S 5428 A
1069 I II 7/17/1967 MILES INC METHOXYPHENAMINE HCL
1773 I II 8/2/1971 CUTTER BIOLOGICAL DIV MILES LABORATORIES INC NORTON PLASTIC S-500-304
3624 I III 9/21/1979 CUTTER BIOLOGICAL DIV MILES LABORATORIES INC IV SOLUTIONS IN POLYOLEFIN BOTTLES
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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