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Generated: October 21, 2018

DrugPatentWatch Database Preview

Drug Master Files for: Amgen Inc

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Amgen Inc Drug Master Files

DMF No. Status Type Submission Date Holder Subject
18672 I II 4/2/2001 AMGEN INC HUMAN MONOCLONAL ANTIBODY (MDX-015)(SP2/0,- AG14 CELLS, MEDAREX) TO IL15
21000 A V 11/12/2007 AMGEN INC AML ASEPTIC PROCESSING WAREHOUSING AND LABORATORIES
22171 I V 11/11/2008 AMGEN INC PRODUCTION MODULE 2 (PM2) ASEPTIC FACILITY LOCATED CO. DUBLIN, IRELAND
29873 A II 11/6/2015 AMGEN INC AMG 191 DRUG SUBSTANCE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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