Dossier DOS-074
Dossier in eCTD format, version 4.2.2, for application COFEPRIS-2021-0074. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-074
Format
eCTD
Version
4.2.2
Status
Draft
Application
Created
2022-03-18
Updated
2023-03-29
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 7 | Completed |
| 2 | CTD Summaries | 11 | Active |
| 3 | Quality | 10 | Blocked |
| 4 | Nonclinical Study Reports | 14 | Blocked |
| 5 | Clinical Study Reports | 6 | Active |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-074 | 3.2.3 | Drug Product | 4.5 | Word | 1,364 | Completed | Sarah Chen |
| CC-174 | 4.4.1 | Toxicology Studies | 10.9 | HTML | 7,862 | Submitted | Lieselotte van der Berg |
| CC-274 | 1.8.2 | Prescribing Information | 3.5 | Word | 8,964 | Failed | Tomoko Ikeda |
| CC-374 | 3.9.7 | Drug Substance | 2.0 | Word | 11,388 | Submitted | Nadia Petrova |
| CC-474 | 5.8.3 | Study Reports – Clinical Pharmacology | 8.6 | Word | 5,405 | Active | Aisha Okonkwo |
| CC-574 | 3.3.5 | Drug Substance | 3.4 | XML | 766 | Completed | Aisha Okonkwo |
| CC-674 | 5.2.8 | Study Reports – Clinical Pharmacology | 4.2 | XML | 6,771 | Overdue | Marcus Webb |
| CC-774 | 5.6.2 | Integrated Summary of Safety | 1.0 | Word | 8,402 | Approved | Tomoko Ikeda |
| CC-874 | 5.5.4 | Integrated Summary of Efficacy | 6.9 | XML | 9,014 | Completed | Dmitri Volkov |
| CC-974 | 3.5.3 | Analytical Methods | 4.6 | XML | 13,780 | Draft | Priya Sharma |
| CC-1074 | 2.6.3 | Quality Overall Summary | 3.6 | HTML | 14,625 | Approved | Lieselotte van der Berg |
| CC-1174 | 1.8.7 | Cover Letter | 8.5 | Word | 7,923 | Blocked | James O'Brien |
| CC-1274 | 3.2.6 | Stability Data | 5.1 | Word | 3,326 | Approved | Priya Sharma |
| CC-1374 | 4.5.2 | Toxicology Studies | 2.0 | Word | 8,704 | Submitted | Nadia Petrova |
| CC-1474 | 1.7.4 | Proposed Conditions of Approval | 5.6 | 10,282 | Approved | Sarah Chen | |
| CC-1574 | 3.6.8 | Container Closure System | 5.2 | 8,987 | Completed | Aisha Okonkwo | |
| CC-1674 | 1.4.9 | Application Form | 4.3 | 11,756 | Submitted | Carlos Mendez | |
| CC-1774 | 4.6.5 | Pharmacokinetics Studies | 3.8 | HTML | 9,154 | Submitted | Priya Sharma |
| CC-1874 | 1.8.2 | Cover Letter | 3.6 | 5,441 | Draft | Nadia Petrova | |
| CC-1974 | 1.7.5 | Patient Labeling | 6.6 | 11,134 | Draft | Sarah Chen |
Showing 20 of 20 components