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An Entity of Type : owl:Class, within Data Space : linked.opendata.cz associated with source document(s)

AttributesValues
rdf:type
rdfs:label
  • Drug Master File
rdfs:subClassOf
Concept_In_Subset
Semantic_Type
  • Intellectual Product
Preferred_Name
  • Drug Master File
UMLS_CUI
  • C2348345
Contributing_Source
  • FDA
ALT_DEFINITION
  • A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The submission of a DMF is not required by law or FDA regulation. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these.FDAeCTD
Legacy_Concept_Name
  • Drug_Master_File
FULL_SYN
  • Drug Master FilePTNCI
  • Drug Master File (DMF)PTFDA
code
  • C70877
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