Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 16, 2019

DrugPatentWatch Database Preview

Drug Master Files for: tobramycin

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tobramycin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12128 I II 9/12/1996 GUANGDONG QINGYUAN NEW NORTH RIVER PHARMACEUTICAL CO LTD TOBRAMYCIN
12151 I II 10/1/1996 GUANGDONG QINGYUAN NEW NORTH RIVER PHARMACEUTICAL CO LTD MANUFACTURING FACILITIES FOR TOBRAMYCIN PHARMACEUTICAL CO., LTD.
13513 I II 9/1/1998 LILLY RESEARCH LABORATORIES TOBRAMYCIN SULFATE
13713 A II 9/1/1998 TEVA PHARMACEUTICAL INDUSTRIES LTD TOBRAMYCIN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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