Dossier DOS-020
Dossier in eCTD format, version 8.4.4, for application MOH-IL-2020-0020. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-020
Format
eCTD
Version
8.4.4
Status
Approved
Application
Created
2022-10-01
Updated
2024-03-13
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 14 | In Progress |
| 2 | CTD Summaries | 8 | Pending |
| 3 | Quality | 6 | Overdue |
| 4 | Nonclinical Study Reports | 4 | Draft |
| 5 | Clinical Study Reports | 9 | Overdue |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-020 | 3.5.2 | Container Closure System | 2.9 | HTML | 4,118 | Approved | James O'Brien |
| CC-120 | 4.3.9 | Toxicology Studies | 8.5 | Word | 9,077 | In Progress | Marcus Webb |
| CC-220 | 3.8.7 | Appendices | 5.9 | HTML | 2,454 | Failed | Lieselotte van der Berg |
| CC-320 | 4.3.3 | Carcinogenicity | 4.5 | 14,857 | Submitted | Nadia Petrova | |
| CC-420 | 1.6.7 | Proposed Conditions of Approval | 5.1 | XML | 12,109 | Active | Dmitri Volkov |
| CC-520 | 5.6.5 | Integrated Summary of Safety | 10.9 | 12,185 | Draft | Tomoko Ikeda | |
| CC-620 | 4.6.6 | Genotoxicity | 11.8 | 8,547 | Overdue | Nadia Petrova | |
| CC-720 | 2.1.6 | Clinical Summary | 9.3 | 6,474 | Submitted | Carlos Mendez | |
| CC-820 | 2.9.8 | Nonclinical Summary | 4.3 | 11,377 | Blocked | Aisha Okonkwo | |
| CC-920 | 4.7.9 | Carcinogenicity | 11.2 | 5,221 | Completed | Dmitri Volkov | |
| CC-1020 | 5.3.2 | Integrated Summary of Safety | 11.0 | HTML | 7,357 | In Progress | Marcus Webb |
| CC-1120 | 2.7.8 | Clinical Summary | 11.8 | HTML | 11,225 | Failed | Lieselotte van der Berg |
| CC-1220 | 4.6.3 | Genotoxicity | 3.9 | HTML | 9,017 | Overdue | Lieselotte van der Berg |
| CC-1320 | 2.5.3 | Clinical Summary | 9.8 | HTML | 9,948 | Overdue | Carlos Mendez |
| CC-1420 | 3.4.3 | Container Closure System | 4.0 | Word | 12,492 | Active | Tomoko Ikeda |
| CC-1520 | 4.7.7 | Toxicology Studies | 2.7 | XML | 4,032 | Blocked | Marcus Webb |
| CC-1620 | 4.9.6 | Pharmacology Studies | 5.0 | 11,061 | Completed | Nadia Petrova | |
| CC-1720 | 1.4.2 | Prescribing Information | 2.2 | Word | 5,100 | Overdue | Nadia Petrova |
| CC-1820 | 5.2.8 | Study Reports – Safety | 11.2 | HTML | 7,881 | Pending | Aisha Okonkwo |
| CC-1920 | 3.5.5 | Drug Substance | 1.7 | Word | 5,367 | Approved | Sarah Chen |
Showing 20 of 20 components