Dossier DOS-051
Dossier in eCTD format, version 5.2.3, for application TFDA-2024-0051. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-051
Format
eCTD
Version
5.2.3
Status
Blocked
Application
Created
2022-03-10
Updated
2023-11-02
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 4 | Draft |
| 2 | CTD Summaries | 4 | Active |
| 3 | Quality | 4 | Blocked |
| 4 | Nonclinical Study Reports | 13 | Completed |
| 5 | Clinical Study Reports | 8 | Overdue |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-051 | 4.4.2 | Genotoxicity | 2.2 | Word | 6,452 | Draft | Nadia Petrova |
| CC-151 | 5.4.1 | Study Reports – Safety | 3.8 | 3,652 | Approved | Marcus Webb | |
| CC-251 | 5.7.8 | Integrated Summary of Safety | 7.0 | XML | 3,246 | Overdue | Carlos Mendez |
| CC-351 | 4.2.4 | Toxicology Studies | 1.4 | Word | 8,012 | Submitted | Carlos Mendez |
| CC-451 | 3.3.3 | Drug Substance | 11.4 | HTML | 14,094 | Active | Aisha Okonkwo |
| CC-551 | 4.6.7 | Pharmacokinetics Studies | 8.1 | XML | 3,172 | Pending | Dmitri Volkov |
| CC-651 | 4.5.9 | Pharmacokinetics Studies | 9.9 | HTML | 3,390 | Active | Marcus Webb |
| CC-751 | 5.4.7 | Study Reports – Clinical Pharmacology | 10.5 | XML | 1,233 | Completed | Tomoko Ikeda |
| CC-851 | 2.4.2 | Clinical Summary | 3.5 | XML | 4,556 | Active | Lieselotte van der Berg |
| CC-951 | 4.6.3 | Toxicology Studies | 12.5 | HTML | 3,935 | Blocked | Dmitri Volkov |
| CC-1051 | 4.1.4 | Pharmacology Studies | 6.9 | HTML | 2,154 | Draft | Aisha Okonkwo |
| CC-1151 | 5.6.1 | Study Reports – Safety | 12.6 | XML | 2,606 | Blocked | Tomoko Ikeda |
| CC-1251 | 4.6.6 | Pharmacokinetics Studies | 1.3 | Word | 5,833 | Completed | James O'Brien |
| CC-1351 | 1.2.8 | Proposed Conditions of Approval | 10.9 | HTML | 2,169 | Submitted | James O'Brien |
| CC-1451 | 4.6.3 | Carcinogenicity | 3.3 | HTML | 7,876 | Draft | Priya Sharma |
| CC-1551 | 5.5.6 | Integrated Summary of Safety | 4.6 | 11,023 | Pending | Nadia Petrova | |
| CC-1651 | 1.4.9 | Patient Labeling | 9.7 | HTML | 4,854 | Draft | Lieselotte van der Berg |
| CC-1751 | 1.2.4 | Application Form | 2.8 | Word | 4,737 | Pending | Aisha Okonkwo |
| CC-1851 | 1.8.3 | Patient Labeling | 2.1 | HTML | 10,560 | Draft | Carlos Mendez |
| CC-1951 | 5.9.1 | Study Reports – Safety | 2.8 | Word | 12,277 | Submitted | James O'Brien |
Showing 20 of 20 components