United States
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| US Module 1 folder (v2.01) |
— Company Name — Submission Date — Application Number — Product name and type — Application Type — Submission Type — Sequence Number — Related Sequence Number |
1 Administrative Information and Prescribing Information folder in US Module 1 assembly template (v2.01) |
When applied to folder in an Assembly that is using the us-2-0-1 XML Definition file creates the usregional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <admin> element of the usregional.xml file. Multiple related sequence number values may be added by separating them with commas. The child folder and leaf elements in this folder complete the remainder of the us-regional.xml file. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| US Module 1 folder (DTD v3.3) |
— Applicant ID — Company Name — Submission Description — Applicant Contact — Application Number — Application Contains Files? — Application Type — Cross- Reference Application — Sequence Number — Submission ID — Submission Type — Submission Sub-Type — Supplement Effective Date Type |
1 Administrative Information folder in US Module 1 assembly template (v3.3) |
When applied to a folder in an Assembly that is using the us-3-3 XML Definition file creates the usregional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <admin> element of the usregional.xml file. The child folders of this folder complete the remainder of the us-regional.xml file. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| US Admin Forms folder | Application Form Type |
The following folders in US Module 1 assembly template (v3.3): — 1.1.1 Form FDA 1571: Investigational New Drug Application (IND) — 1.1.2 Form FDA 356h: Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use folders in |
Creates the appropriate <form formtype=""> element within the <submission-information> element in us-regional.xml. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
| US Forms folder | Application Form Type |
The following folders in US Module 1 assembly template (v3.3): — 1.1.3 Form FDA 3397: User Fee Cover Sheet — 1.1.4 Form FDA 2252: Transmittal of Annual Reports for Drugs and Biologics for Human Use — 1.1.5 Form FDA 2253: Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use — 1.1.6 Form FDA 2567: Transmittal of Labels and Circulars — 1.1.7 Form FDA 3674: Certification of Compliance — 1.1.8 Form FDA 3792: Biosimilar User Fee Cover Sheet (BsUFA) — 1.1.9 Form FDA 3794: Generic Drug User Fee Cover Sheet (GDUFA) |
Creates the appropriate <form formtype=""> element within the <m1-1forms> element in usregional.xml. |
| Extension Type | Associated Attributes |
Applied to Assembly Element |
Result |
|
Promotional Material Audience Type folder |
Promotional Material Audience Type |
1.15 Promotional Material Audience Type folder in US Module 1 assembly template (v3.3) |
Creates the appropriate <m1-15promotional-material> element in us-regional.xml. The value of the attribute populated on this folder is used to complete the promotionalmaterial-audience-type attribute of <m1-15-promotional-material> element. |
| Promotional Material Doc Type folder |
Promotional Material Doc Type |
1.15.2 Materials folder in US Module 1 assembly template (v3.3) |
Creates the appropriate <m1-15-2materials> element in usregional.xml. The value of the attribute populated on this folder is used to complete the promotionalmaterial-doc-type attribute of <m1-15-2-materials> element. |
|
Promotional Material Type folder |
— Promotional Material Type — Promotional Material ID — Issue Date |
1.15.2.1 Material folder in US Module 1 assembly template (v3.3) |
Creates the appropriate <m1-15-2-1material> element in usregional.xml. The values of the attributes populated on this folder are used to complete the attributes <m1-15-2-1-material> element. |