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eCTD Attributes United States

You can use the following attributes to describe eCTD submissions for the United States.

United States-v2.01

Attribute Description
Application Number The number assigned to the application.
Application Type The type of the application.
Company Name The company presenting the submission.
Product Name The product or products that are being addressed in the application.
Related Sequence Number Any sequence related to the registered product name. Click Add to create additional rows for adding more related sequences.
Sequence Number The number for the initial sequence for filing.
Submission Date The effective date for the submission.
Submission Type The type of the submission.

United States-v3.3

Attribute Description
Applicant Contact The Applicant Contact for the submission.
Applicant ID The D-U-N-S® number identifier for the business entity that is the sponsor, applicant, or holder of the submission.The same D-U-N-S number should be used for all submissions to an application, unless there is a change in ownership of the application. The default value is taken from the Application level value. If not defined at the Application level, the default for United States region in Data Administration is used.
Application Contains Files? Indicates if the application contains the files in a grouped submission.
Application Number The application number provided by the agency.
Application Type The type of application.
Company Name The sponsor or applicant name.
Cross-Reference Application The application number and type of cross-reference applications. Should only be provided when an application makes reference to other application. Multiple paired values can be provided.
Sequence Number The sequence number of the submission. It should start at 0001, and should not exceed 9999.
Submission Description The description of the submission to be included in the XML.
Submission ID The sequence number of the first submission that refers to the same regulatory activity as the sequence that is being submitted.
Submission Sub-Type The filing/submission sub-type for the submission. Dependent on the value selected for Submission Type.
Submission Type The filing/submission type for the submission. Dependent on the selected Application Type.
Supplement Effective Date Type The supplement effective date type for the submission. Dependent on the selected Submission Type.