| agencyName
|
string
|
Agency
|
The name of the agency that the submission is being sent to.
|
|
|
| applicant
|
string
|
Applicant
|
The name of the applicant filing the submission.
|
|
|
| applicationNumber
|
string
|
Application Number
|
The Application Number as provided by the agency. Multiple comma-separated values can be provided.
|
Application Code
|
|
| dmfHolder
|
string
|
DMF Holder
|
The Drug Master File Holder for the Product the submission is for.
|
|
|
| dmfNumber
|
string
|
DMF Number
|
The Drug Master File Number for the Product the submission is for.
|
|
|
| inn
|
string
|
INN
|
The INN of the product being submitted for approval. Multiple comma-separated values can be provided.
|
|
|
| inventedName
|
string
|
Invented Name
|
The invented name of the Product being submitted. Multiple comma-separated values can be provided.
|
|
|
| paragraph13LTP
|
string
|
Paragraph 13 LTP
|
Identifies the submission as Paragraph 13 TPA.
|
|
|
| pmfHolder
|
string
|
PMF Holder
|
The Plasma Master File Holder for the Product the submission is for.
|
|
|
| pmfNumber
|
string
|
PMF Number
|
The Plasma Master File Number for the Product the submission is for.
|
|
|
| relatedSequence
|
string
|
Related Sequence
|
This is the Sequence number of a previous submission to which this submission relates. Multiple related sequence numbers may be entered as comma-separated values.
|
|
|
| sequenceNumber
|
string
|
Sequence Number
|
The Sequence Number for this submission.
|
Sequence Code (without prefix "P")
|
|
| submissionDescription
|
string
|
Submission Description
|
The description of the Submission to be included in the XML.
|
|
|
| submissionType
|
string
|
Submission Type
|
The Filing type of the submission. Based on the Sequence's Filing Type eCTD Code in
Calyx RIM, otherwise blank.
|
na-nas, na-ngf, na-nko, na-bws, na-gen, na-ie, na-nde, na-ndo, notification, var-authorisation-scientific, var-authorisation-admin, renewal, psur, pi, eas, co-marketing, withdrawal, var-pi, transfer, dmf, pmf, reformat, supplemental-info-to, corrigendum
|
|