Category: N

NCT Number

ClinicalTrials.gov identifier – The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is “NCT” followed by an 8-digit number

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Novel Excipient

A material or a composition that has not been previously used in an approved drug product in the US (i.e. not listed in FDA Inactive

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Node Extension

Node extensions are a way of providing extended organisational information in the eCTD. The node extension should be visualised as an extra heading in the

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