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Generated: October 19, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Celgene

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Celgene Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12079 I II 8/7/1996 CELGENE CORP FR901228
28533 A II 6/10/2015 ABRAXIS BIOSCIENCE LLC A WHOLLY OWNED SUB OF CELGENE CORP IDN 5404 ALBUMIN-BOUND PARTICLES FOR INJECTABLE SUSPENSION (COMPANY CODE: ABI-011)
28535 A II 4/14/2015 ABRAXIS BIOSCIENCE LLC A WHOLLY OWNED SUB OF CELGENE CORP RAPAMYCIN PROTEIN BOUND PARTICLE FOR INJECTABLE SUSPENSION (COMPANY CODE: ABI-009)
30795 A V 8/31/2016 CELGENE CORP LENALIDOMIDE REMS HOSTED SYSTEM
32253 A V 5/31/2018 CELGENE CORP THALIDOMIDE REMS HOSTED SYSTEM
32574 A II 5/4/2018 CELGENE CORP MARIZOMIB, A LYOPHILIZED POWDER FOR INJECTION WITH ACCOMPANYING DILUENT
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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