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Generated: September 22, 2018

DrugPatentWatch Database Preview

Drug Master Files for: BACITRACIN ZINC; POLYMYXIN B SULFATE

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BACITRACIN ZINC; POLYMYXIN B SULFATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13323 I II 9/1/1998 ASTRA LAKEMEDEL AB BACITRACIN
13340 I II 9/1/1998 ALPHAPHARM PARTY LTD BACITRACIN
13341 A II 9/1/1998 XELLIA PHARMACEUTICALS APS BACITRACIN STERILE USP
13344 I II 9/1/1998 ALPHAPHARM PARTY LTD BACITRACIN ZINC
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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McKinsey
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US Department of Justice
Moodys

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