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Generated: October 15, 2018

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Drug Master Files for: KANAMYCIN SULFATE

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KANAMYCIN SULFATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13325 I II 9/1/1998 BRISTOL MYERS SQUIBB CO KANAMYCIN SULFATE
13392 I II 9/1/1998 MEIJI SEIKA KAISHA LTD KANAMYCIN SULFATE
13599 I II 9/1/1998 PIERREL AMERICA INC KANAMYCIN SULFATE
13628 I II 9/1/1998 SHANGHAI ASIA PIONEER PHARMACEUTICALS CO LTD KANAMYCIN SULFATE
28275 A II 5/6/2014 LIVZON GROUP FUZHOU FUXING PHARMACEUTICAL CO LTD KANAMYCIN SULFATE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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Daiichi Sankyo
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Chinese Patent Office
Fish and Richardson

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