Dossier DOS-096
Dossier in CTD format, version 8.5.8, for application TITCK-2024-0096. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-096
Format
CTD
Version
8.5.8
Status
Draft
Application
Created
2022-05-04
Updated
2023-12-21
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 3 | Completed |
| 2 | CTD Summaries | 14 | Pending |
| 3 | Quality | 7 | In Progress |
| 4 | Nonclinical Study Reports | 3 | Active |
| 5 | Clinical Study Reports | 15 | Overdue |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-096 | 1.9.3 | Patient Labeling | 11.7 | 8,578 | Draft | Carlos Mendez | |
| CC-196 | 1.5.8 | Patient Labeling | 9.8 | Word | 8,692 | Active | James O'Brien |
| CC-296 | 4.7.7 | Toxicology Studies | 6.9 | HTML | 12,676 | Active | Priya Sharma |
| CC-396 | 1.9.8 | Application Form | 6.3 | 4,804 | Failed | James O'Brien | |
| CC-496 | 3.2.9 | Analytical Methods | 5.9 | Word | 5,961 | Draft | Priya Sharma |
| CC-596 | 3.9.1 | Manufacturing Process | 12.8 | HTML | 14,193 | Pending | Carlos Mendez |
| CC-696 | 2.8.5 | Clinical Summary | 7.4 | HTML | 14,688 | Approved | Dmitri Volkov |
| CC-796 | 2.9.7 | Quality Overall Summary | 8.4 | Word | 4,927 | Submitted | Lieselotte van der Berg |
| CC-896 | 2.1.5 | Clinical Summary | 12.5 | Word | 13,460 | Blocked | Aisha Okonkwo |
| CC-996 | 3.8.8 | Analytical Methods | 10.9 | XML | 14,587 | Pending | James O'Brien |
| CC-1096 | 5.3.7 | Study Reports – Safety | 9.1 | HTML | 14,549 | Pending | Marcus Webb |
| CC-1196 | 3.1.6 | Appendices | 4.6 | Word | 5,329 | Overdue | Aisha Okonkwo |
| CC-1296 | 5.2.5 | Integrated Summary of Efficacy | 10.3 | HTML | 8,071 | Completed | Carlos Mendez |
| CC-1396 | 5.1.3 | Integrated Summary of Safety | 11.4 | 4,884 | Failed | Lieselotte van der Berg | |
| CC-1496 | 4.7.4 | Pharmacology Studies | 8.6 | XML | 7,947 | Overdue | Lieselotte van der Berg |
| CC-1596 | 5.8.5 | Study Reports – Efficacy | 3.8 | HTML | 11,293 | In Progress | James O'Brien |
| CC-1696 | 1.6.1 | Application Form | 3.0 | 14,889 | Completed | James O'Brien | |
| CC-1796 | 4.2.4 | Pharmacology Studies | 2.1 | HTML | 14,525 | Blocked | Marcus Webb |
| CC-1896 | 4.7.2 | Carcinogenicity | 7.5 | Word | 5,025 | Active | Nadia Petrova |
| CC-1996 | 1.4.6 | Patient Labeling | 12.7 | Word | 10,666 | Draft | Marcus Webb |
Showing 20 of 20 components