Dossier DOS-094
Dossier in eCTD format, version 1.9.8, for application COFEPRIS-2021-0094. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-094
Format
eCTD
Version
1.9.8
Status
In Progress
Application
Created
2022-08-29
Updated
2024-05-29
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 5 | Completed |
| 2 | CTD Summaries | 6 | Active |
| 3 | Quality | 5 | Completed |
| 4 | Nonclinical Study Reports | 8 | Active |
| 5 | Clinical Study Reports | 9 | Pending |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-094 | 2.4.7 | Nonclinical Overview | 9.8 | XML | 9,959 | Draft | Marcus Webb |
| CC-194 | 3.6.4 | Drug Substance | 1.4 | Word | 6,600 | In Progress | Marcus Webb |
| CC-294 | 1.2.9 | Cover Letter | 8.8 | XML | 11,718 | Completed | Aisha Okonkwo |
| CC-394 | 4.4.6 | Carcinogenicity | 3.7 | 5,975 | Failed | Dmitri Volkov | |
| CC-494 | 1.6.4 | Prescribing Information | 3.1 | 8,344 | In Progress | Aisha Okonkwo | |
| CC-594 | 1.8.3 | Prescribing Information | 12.1 | HTML | 6,496 | Draft | Tomoko Ikeda |
| CC-694 | 5.4.9 | Study Reports – Safety | 6.7 | 3,580 | Overdue | Dmitri Volkov | |
| CC-794 | 1.9.5 | Patient Labeling | 6.8 | HTML | 6,959 | Approved | James O'Brien |
| CC-894 | 2.6.8 | Clinical Summary | 9.7 | HTML | 1,388 | Completed | James O'Brien |
| CC-994 | 4.2.8 | Pharmacology Studies | 1.9 | XML | 4,765 | Pending | Nadia Petrova |
| CC-1094 | 1.6.2 | Application Form | 1.3 | XML | 6,153 | Overdue | Tomoko Ikeda |
| CC-1194 | 1.6.1 | Cover Letter | 11.6 | Word | 2,566 | Submitted | Priya Sharma |
| CC-1294 | 5.7.8 | Integrated Summary of Safety | 12.2 | XML | 10,216 | Completed | Dmitri Volkov |
| CC-1394 | 4.9.1 | Carcinogenicity | 5.8 | Word | 12,428 | Active | Priya Sharma |
| CC-1494 | 3.3.1 | Drug Product | 11.5 | HTML | 2,510 | Active | Aisha Okonkwo |
| CC-1594 | 3.6.6 | Manufacturing Process | 10.6 | HTML | 619 | Approved | Lieselotte van der Berg |
| CC-1694 | 3.4.9 | Appendices | 6.2 | Word | 2,169 | Draft | Priya Sharma |
| CC-1794 | 4.6.6 | Toxicology Studies | 5.6 | Word | 10,209 | Submitted | Marcus Webb |
| CC-1894 | 3.1.6 | Container Closure System | 5.3 | Word | 4,613 | Active | Carlos Mendez |
| CC-1994 | 3.3.4 | Manufacturing Process | 10.2 | 9,885 | Overdue | Tomoko Ikeda |
Showing 20 of 20 components