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Generated: June 16, 2019

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Drug Master Files for: ALBUMIN HUMAN

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ALBUMIN HUMAN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
18650 I II 1/12/1998 NEORX CORP MURINE MONOCLONAL ANTIBODY (NR-LU-10)/STREPTAVIDIN CONJUGATE, BIOTIN-GALACTOSE-HUMAN SERUM ALBUMIN, YTTRIUM-Y-90-DOTA-BIOTIN
24066 I II 8/10/2010 SPECTRON MRC LLC GALLIUM GA68 ALBUMIN AGGREGATED ([68GA]MAA)
28468 A II 7/14/2014 IRVINE SCIENTIFIC SALES CO HUMAN SERUM ALBUMIN SOLUTION, PRODUCT #9988
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)
29648 A IV 11/26/2015 WUHAN HEALTHGEN BIOTECHNOLOGY CORP RECOMBINANT HUMAN SERUM ALBUMIN
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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