| agencyName
|
string
|
Agency
|
Name of the agency that the submission is being sent to.
|
N/A
|
N/A
|
| applicant
|
string
|
Applicant
|
Name of the company filing the submission.
|
N/A
|
N/A
|
| applicationNumber
|
string
|
Application Number
|
Application Number provided by the agency. Multiple comma-separated values can be provided.
|
Application Code
|
Application Code
|
| dmfHolder
|
string
|
DMF Holder
|
Drug Master File Holder for the Product the submission is for.
|
N/A
|
N/A
|
| dmfNumber
|
string
|
DMF Number
|
Drug Master File Number for the Product the submission is for (alphanumeric).
|
N/A
|
N/A
|
| inn
|
string
|
INN
|
INN of the product being submitted for approval. Each INN is a unique name that is globally recognized and is public property. Multiple comma-separated values can be provided
|
N/A
|
N/A
|
| inventedName
|
string
|
Invented Name
|
Invented name of the Product being submitted. Multiple comma-separated values can be provided.
|
N/A
|
N/A
|
| paragraph13LTP
|
string
|
Article 13 TPA
|
Identifies the submission as Article 13 TPA.
|
|
N/A
|
| pmfHolder
|
string
|
PMF Holder
|
Plasma Master File Holder for the Product the submission is for.
|
N/A
|
N/A
|
| pmfNumber
|
string
|
PMF Number
|
Plasma Master File Number for the Product the submission is for.
|
N/A
|
N/A
|
| relatedSequence
|
string
|
Related Sequence
|
Sequence Number of a previous submission to which this submission relates. Multiple related sequence numbers may be entered as comma-separated values
|
N/A
|
N/A
|
| sequenceNumber
|
string
|
Sequence Number
|
Sequence Number for this submission.
|
Sequence Code (without prefix "P")
|
N/A
|
| submissionDescription
|
string
|
Submission Description
|
Description of the Submission to be included in the XML.
|
N/A
|
N/A
|
| submissionType
|
string
|
Submission Type
|
Filing Type of the submission. Based on the Filing Type eCTD Code of the Sequence in
Calyx RIM, otherwise blank.
|
eCTD Code value from
|
N/A
|