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Generated: November 14, 2018

DrugPatentWatch Database Preview

Drug Master Files for: cisplatin

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cisplatin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10898 I II 5/13/1994 INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTD CISPLATIN DRUG SUBSTANCE
11629 I II 8/17/1995 DEGUSSA AG WERK RADEBEUL MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CISPLATIN USP IN HANAU, GERMANY.
12012 I II 6/24/1996 DEGUSSA AG WERK RADEBEUL CISPLATIN
21917 A II 8/29/2008 LAURUS LABS LTD CISPLATIN USP DRUG SUBSTANCE
23985 A II 5/22/2010 QILU PHARMACEUTICAL CO LTD CISPLATIN (NON STERILE API)
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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