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Generated: November 18, 2018

DrugPatentWatch Database Preview

Drug Master Files for: gentamicin

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gentamicin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12048 A II 6/30/1996 FUJIAN FUKANG PHARMACEUTICAL CO LTD GENTAMICIN SULFATE
12177 I I 10/17/1996 FUZHOU ANTIBIOTIC GENERAL FACTORY MANUFACTURING FACILITIES FOR GENTAMICIN SULFATE IN FUZHOU, P.R. CHINA
13437 I II 9/1/1998 SCHERING PHARMACEUTICAL CORP GENTAMICIN SULFATE
13620 I II 9/1/1998 GIST-BROCADES NV PHARMACEUTICALS GENTAMICIN SULFATE
13625 I II 9/1/1998 PHARMACHIM ECONOMIC CORP GENTAMICIN SULFATE
13630 I II 9/1/1998 SHANGHAI ASIA PIONEER PHARMACEUTICALS CO LTD GENTAMICIN SULFATE
13637 I II 9/1/1998 SICHUAN LONG MARCH PHARMACEUTICAL CO LTD GENTAMICIN 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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