Dossier DOS-073
Dossier in eCTD format, version 8.2.8, for application CDSCO-2022-0073. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-073
Format
eCTD
Version
8.2.8
Status
Draft
Application
Created
2022-02-28
Updated
2023-12-18
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 10 | Blocked |
| 2 | CTD Summaries | 15 | Draft |
| 3 | Quality | 3 | Overdue |
| 4 | Nonclinical Study Reports | 12 | Completed |
| 5 | Clinical Study Reports | 10 | Overdue |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-073 | 2.2.5 | Nonclinical Overview | 1.0 | Word | 3,962 | Overdue | Tomoko Ikeda |
| CC-173 | 2.9.3 | Nonclinical Summary | 10.6 | XML | 4,039 | Pending | James O'Brien |
| CC-273 | 1.5.9 | Cover Letter | 11.8 | HTML | 639 | Blocked | Tomoko Ikeda |
| CC-373 | 4.1.3 | Genotoxicity | 10.9 | Word | 14,759 | Pending | Tomoko Ikeda |
| CC-473 | 5.7.1 | Integrated Summary of Efficacy | 2.7 | Word | 7,171 | Submitted | Marcus Webb |
| CC-573 | 4.9.1 | Carcinogenicity | 1.9 | 10,184 | Overdue | Aisha Okonkwo | |
| CC-673 | 4.7.4 | Carcinogenicity | 10.7 | 549 | Submitted | James O'Brien | |
| CC-773 | 5.8.5 | Study Reports – Safety | 6.7 | XML | 1,769 | Active | Nadia Petrova |
| CC-873 | 4.1.2 | Carcinogenicity | 6.3 | 3,661 | Submitted | James O'Brien | |
| CC-973 | 4.5.3 | Genotoxicity | 11.1 | 1,042 | Completed | Dmitri Volkov | |
| CC-1073 | 4.6.9 | Toxicology Studies | 4.7 | XML | 4,902 | In Progress | Tomoko Ikeda |
| CC-1173 | 4.6.8 | Toxicology Studies | 1.3 | XML | 9,470 | Active | James O'Brien |
| CC-1273 | 5.4.3 | Study Reports – Efficacy | 5.8 | Word | 11,384 | Submitted | Sarah Chen |
| CC-1373 | 3.7.6 | Manufacturing Process | 12.6 | 8,951 | Approved | Lieselotte van der Berg | |
| CC-1473 | 1.1.7 | Prescribing Information | 5.4 | 3,861 | Pending | Carlos Mendez | |
| CC-1573 | 2.2.3 | Clinical Summary | 4.7 | XML | 4,483 | In Progress | Tomoko Ikeda |
| CC-1673 | 2.5.6 | Clinical Summary | 2.0 | Word | 9,272 | In Progress | Dmitri Volkov |
| CC-1773 | 1.6.9 | Proposed Conditions of Approval | 10.6 | 6,668 | Completed | Priya Sharma | |
| CC-1873 | 2.7.6 | Nonclinical Overview | 3.3 | HTML | 7,792 | Completed | James O'Brien |
| CC-1973 | 4.2.8 | Pharmacology Studies | 5.7 | HTML | 13,453 | Active | Aisha Okonkwo |
Showing 20 of 20 components