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 6, 2019

DrugPatentWatch Database Preview

Drug Master Files for: etoposide

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etoposide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10191 I II 4/13/1993 PHARMACEUTICAL FACTORY SHANGHAI INSTITUTE PHARMACEUTICAL INDUSTRY ETOPOSIDE
10476 A II 9/17/1993 NIPPON KAYAKU CO LTD ETOPOSIDE PHOSPHATE
10642 A II 12/30/1993 CIPLA LTD ETOPOSIDE USP
13986 I II 2/17/1999 RP SCHERER CANADA INC ETOPOSIDE 50MG SOFT-GELATIN CAPSULE
24332 I II 10/8/2010 QILU PHARMACEUTICAL CO LTD ETOPOSIDE (NON-STERILE API)
4385 I II 11/6/1981 SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT ETOPOSIDE (VP 16-213) (ETHYLIDENE)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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