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Generated: May 25, 2019

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Drug Master Files for: STREPTOMYCIN SULFATE

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STREPTOMYCIN SULFATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
104 I 1/1/1940 CHAS PFIZER AND CO INC STREPTOMYCIN HYDRAZIDE ISONICOTINYL
13376 I II 9/1/1998 PFIZER INC STREPTOMYCIN SULFATE
13401 I II 9/1/1998 GLAXO STREPTOMYCIN SULFATE
13402 I II 9/1/1998 GLAXO GROUP RESEARCH LTD DIHYDROSTREPTOMYCIN SULFATE
13442 I II 9/1/1998 RHONE POULENC RORER PHARMACEUTICALS INC DIHYDROSTREPTOMYCIN SULFATE
13485 I II 9/1/1998 RHONE POULENC RORER PHARMACEUTICALS INC STREPTOMYCIN 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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