Preferred Label : Labeling Supplement;
Alternative definition : FDA: 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.;
Origin ID : C97023;
UMLS CUI : C3273193;
Semantic type(s)
- concept_is_in_subset
