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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
  • Labeling Supplement
rdfs:subClassOf
Concept_In_Subset
Semantic_Type
  • Intellectual Product
Preferred_Name
  • Labeling Supplement
NCI_META_CUI
  • CL429579
Contributing_Source
  • FDA
ALT_DEFINITION
  • For NDAs, ANDAs, and BLAs, this represents a request to modify an existing label that do not rise to the level of an efficacy supplement for purposes such as adding additional safety information, clarification, etc. Labeling supplements may only be submitted once the original-application has been approved/licensed.FDAeCTD
FULL_SYN
  • Labeling SupplementPTFDA
  • Labeling SupplementPTNCI
code
  • C97023
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