Dossier DOS-097
Dossier in CTD format, version 4.2.8, for application SFDA-2023-0097. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-097
Format
CTD
Version
4.2.8
Status
Blocked
Application
Created
2022-08-13
Updated
2024-06-07
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 9 | In Progress |
| 2 | CTD Summaries | 7 | Submitted |
| 3 | Quality | 9 | Active |
| 4 | Nonclinical Study Reports | 7 | Submitted |
| 5 | Clinical Study Reports | 3 | Pending |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-097 | 2.3.5 | Nonclinical Summary | 5.7 | 10,444 | Completed | Priya Sharma | |
| CC-197 | 3.1.5 | Stability Data | 6.3 | Word | 12,972 | Failed | Marcus Webb |
| CC-297 | 5.8.1 | Integrated Summary of Efficacy | 7.4 | HTML | 5,040 | Blocked | Aisha Okonkwo |
| CC-397 | 4.4.8 | Toxicology Studies | 12.9 | Word | 9,096 | Completed | Marcus Webb |
| CC-497 | 3.7.5 | Analytical Methods | 3.6 | 14,466 | Approved | Lieselotte van der Berg | |
| CC-597 | 4.8.8 | Carcinogenicity | 1.7 | HTML | 8,374 | Blocked | James O'Brien |
| CC-697 | 3.1.6 | Container Closure System | 4.6 | Word | 2,910 | Failed | Carlos Mendez |
| CC-797 | 2.9.2 | Nonclinical Overview | 8.1 | XML | 10,811 | Blocked | Carlos Mendez |
| CC-897 | 2.8.6 | Quality Overall Summary | 6.5 | HTML | 11,210 | Overdue | Marcus Webb |
| CC-997 | 1.5.4 | Patient Labeling | 5.6 | 7,458 | Draft | Dmitri Volkov | |
| CC-1097 | 2.2.1 | Nonclinical Overview | 5.6 | 9,022 | Submitted | Sarah Chen | |
| CC-1197 | 4.1.2 | Pharmacokinetics Studies | 1.1 | 7,008 | Submitted | Aisha Okonkwo | |
| CC-1297 | 1.1.2 | Patient Labeling | 5.0 | XML | 1,626 | Overdue | Dmitri Volkov |
| CC-1397 | 3.6.5 | Stability Data | 11.0 | HTML | 1,312 | Blocked | Priya Sharma |
| CC-1497 | 5.8.7 | Study Reports – Safety | 3.3 | HTML | 5,119 | In Progress | Lieselotte van der Berg |
| CC-1597 | 2.8.4 | Quality Overall Summary | 10.7 | XML | 14,281 | Pending | Lieselotte van der Berg |
| CC-1697 | 1.6.7 | Application Form | 1.2 | XML | 5,688 | Active | Dmitri Volkov |
| CC-1797 | 5.3.6 | Integrated Summary of Efficacy | 4.2 | Word | 2,661 | In Progress | James O'Brien |
| CC-1897 | 5.1.6 | Study Reports – Clinical Pharmacology | 3.5 | Word | 8,511 | Draft | Carlos Mendez |
| CC-1997 | 3.6.7 | Container Closure System | 12.9 | XML | 7,184 | Submitted | Priya Sharma |
Showing 20 of 20 components