m1-us v. 1.0

Field Name Field Type Matching UI Field Description Acceptable Values Default Value
companyName string Company Name The name of the company sending the submission.
submissionDate date Submission Date The date the submission is to be submitted. Date format - Unix Timestamp
applicationNumber string Application Number The Application Number provided by the agency.
productName string Product Name The name or proposed product (trade) name(s) to be used in the Certificate of Registration. If duplicate products are being submitted within one application, all products should be listed. Multiple comma-separated values can be provided.
applicationType string Application Type The Application Type for this Application. Based on a mapping of the eCTD code to the Application Type selected on the related Application.
  • nda
  • anda
  • bla
  • dmf
  • ind
  • master-file
submissionType string Submission Type The Filing type of the submission. Will default from the Sequence's Filing Type.
  • amendment
  • annual-report
  • chemistry-manufacturing-controls-supplement
  • efficacy-supplement
  • establishment-description-supplement
  • labeling-supplement
  • original-application
  • other
  • presubmission
  • resubmission
sequenceNumber string Sequence Number The Sequence Number for this submission. Sequence Code (without prefix "P")
relatedSequenceNumber string Related Sequence Number The related sequence number for this submission.