Dossier DOS-060
Dossier in eCTD format, version 5.4.3, for application MOH-IL-2020-0060. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-060
Format
eCTD
Version
5.4.3
Status
Active
Application
Created
2022-05-17
Updated
2024-05-25
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 6 | Active |
| 2 | CTD Summaries | 11 | Pending |
| 3 | Quality | 10 | Pending |
| 4 | Nonclinical Study Reports | 10 | Active |
| 5 | Clinical Study Reports | 15 | Active |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-060 | 2.1.5 | Clinical Overview | 4.8 | Word | 12,052 | Draft | Priya Sharma |
| CC-160 | 2.8.4 | Quality Overall Summary | 11.4 | Word | 5,601 | Submitted | Tomoko Ikeda |
| CC-260 | 3.4.6 | Drug Substance | 11.0 | 3,145 | Overdue | Carlos Mendez | |
| CC-360 | 5.2.7 | Integrated Summary of Efficacy | 4.6 | Word | 9,934 | In Progress | Carlos Mendez |
| CC-460 | 5.1.3 | Study Reports – Efficacy | 1.1 | Word | 10,772 | In Progress | Carlos Mendez |
| CC-560 | 1.1.7 | Patient Labeling | 11.7 | XML | 6,383 | Active | Carlos Mendez |
| CC-660 | 4.9.6 | Carcinogenicity | 5.4 | 559 | In Progress | Dmitri Volkov | |
| CC-760 | 3.8.3 | Analytical Methods | 8.4 | HTML | 7,494 | Draft | Sarah Chen |
| CC-860 | 3.3.2 | Drug Substance | 11.7 | HTML | 14,128 | Failed | Tomoko Ikeda |
| CC-960 | 5.9.4 | Study Reports – Efficacy | 3.3 | XML | 4,571 | Blocked | Tomoko Ikeda |
| CC-1060 | 4.4.9 | Pharmacokinetics Studies | 7.4 | XML | 5,678 | Submitted | Priya Sharma |
| CC-1160 | 1.9.5 | Proposed Conditions of Approval | 12.6 | XML | 7,496 | In Progress | Lieselotte van der Berg |
| CC-1260 | 3.9.6 | Drug Substance | 11.3 | XML | 6,426 | Pending | Priya Sharma |
| CC-1360 | 2.9.5 | Clinical Overview | 4.0 | 8,389 | Approved | Lieselotte van der Berg | |
| CC-1460 | 4.3.5 | Pharmacokinetics Studies | 1.9 | XML | 5,604 | In Progress | Aisha Okonkwo |
| CC-1560 | 2.2.1 | Clinical Summary | 2.8 | Word | 9,228 | Overdue | Marcus Webb |
| CC-1660 | 4.4.1 | Toxicology Studies | 7.6 | Word | 11,606 | Active | Sarah Chen |
| CC-1760 | 3.6.8 | Container Closure System | 4.1 | XML | 8,131 | Active | Tomoko Ikeda |
| CC-1860 | 4.3.9 | Pharmacology Studies | 2.4 | HTML | 8,282 | Overdue | Aisha Okonkwo |
| CC-1960 | 1.7.1 | Patient Labeling | 7.6 | 10,830 | In Progress | Carlos Mendez |
Showing 20 of 20 components