Dossier DOS-040
Dossier in NeeS format, version 7.0.6, for application MOH-IL-2020-0040. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-040
Format
NeeS
Version
7.0.6
Status
In Progress
Application
Created
2022-07-17
Updated
2023-07-08
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 9 | Completed |
| 2 | CTD Summaries | 8 | Failed |
| 3 | Quality | 6 | Failed |
| 4 | Nonclinical Study Reports | 5 | Completed |
| 5 | Clinical Study Reports | 9 | In Progress |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-040 | 2.4.8 | Nonclinical Overview | 7.7 | 4,851 | Pending | Tomoko Ikeda | |
| CC-140 | 4.3.5 | Pharmacokinetics Studies | 5.2 | HTML | 5,548 | Pending | Tomoko Ikeda |
| CC-240 | 2.3.1 | Nonclinical Overview | 3.9 | XML | 14,127 | Approved | Aisha Okonkwo |
| CC-340 | 5.8.3 | Study Reports – Safety | 5.5 | Word | 7,323 | Completed | Lieselotte van der Berg |
| CC-440 | 4.6.5 | Genotoxicity | 2.3 | Word | 4,685 | Draft | Marcus Webb |
| CC-540 | 1.3.3 | Patient Labeling | 11.7 | Word | 11,641 | Completed | Carlos Mendez |
| CC-640 | 4.6.3 | Pharmacokinetics Studies | 12.2 | Word | 9,766 | Submitted | Lieselotte van der Berg |
| CC-740 | 3.1.1 | Container Closure System | 1.5 | 13,489 | Overdue | Marcus Webb | |
| CC-840 | 5.3.2 | Integrated Summary of Efficacy | 12.4 | Word | 10,096 | Draft | Priya Sharma |
| CC-940 | 2.7.9 | Nonclinical Overview | 11.1 | 3,798 | In Progress | Lieselotte van der Berg | |
| CC-1040 | 1.4.3 | Cover Letter | 4.9 | 10,187 | Active | James O'Brien | |
| CC-1140 | 1.1.5 | Prescribing Information | 6.7 | HTML | 12,505 | Completed | Tomoko Ikeda |
| CC-1240 | 2.8.7 | Nonclinical Summary | 11.4 | Word | 9,182 | Draft | Tomoko Ikeda |
| CC-1340 | 2.6.6 | Nonclinical Summary | 4.5 | HTML | 6,799 | Pending | Tomoko Ikeda |
| CC-1440 | 1.5.2 | Prescribing Information | 10.6 | Word | 6,655 | Draft | Carlos Mendez |
| CC-1540 | 1.5.3 | Patient Labeling | 6.4 | XML | 7,441 | Completed | Carlos Mendez |
| CC-1640 | 3.1.5 | Container Closure System | 8.3 | Word | 14,527 | Submitted | Dmitri Volkov |
| CC-1740 | 4.2.8 | Pharmacology Studies | 6.8 | 2,605 | Active | Dmitri Volkov | |
| CC-1840 | 2.5.6 | Nonclinical Overview | 10.9 | XML | 871 | Submitted | Priya Sharma |
| CC-1940 | 4.5.1 | Pharmacokinetics Studies | 1.8 | HTML | 3,890 | Approved | James O'Brien |
Showing 20 of 20 components