About: New Drug Application

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

Attributes	Values
rdf:type	Class
rdfs:label	New Drug Application
rdfs:subClassOf	Application to Market New Drug, Biologic, or Antibiotic for Human Use
Concept_In_Subset	Stability Study Data File Reason Terminology FDA eCTD Terminology eCTD Application Type Terminology
Semantic_Type	Intellectual Product
Preferred_Name	New Drug Application
UMLS_CUI	C2347344
Contributing_Source	FDA
ALT_DEFINITION	A type of application which a pharmaceutical manufacturer or its agent requests permission from the United States Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications; besides a chemical and pharmacologic description of the drug, the application must show the results of clinical trials conducted with respect to the indication for which a license is requested.FDAeCTD Stability data submitted to a new human drug application.FDAStability
Legacy_Concept_Name	New_Drug_Application
FULL_SYN	New Drug Application (NDA)PTFDA NDAABNCI New Drug ApplicationPTFDA New Drug ApplicationPTNCI
code	C72899
is rdfs:subClassOf of	505(b)(1) New Drug Application Investigational New Drug Application New Drug Application (CBER) New Drug Application (CDER) 505(b)(2) New Drug Application

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