Dossier DOS-081

Dossier in NeeS format, version 7.1.2, for application FDA-2024-0081. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-081
Format
NeeS
Version
7.1.2
Status
Overdue
Application
FDA-2024-0081
Created
2022-10-01
Updated
2023-04-18
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information9Active
2CTD Summaries13Pending
3Quality12Submitted
4Nonclinical Study Reports12Completed
5Clinical Study Reports10Failed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0811.6.4Prescribing Information8.4HTML6,836CompletedLieselotte van der Berg
CC-1811.3.6Patient Labeling12.8XML9,677BlockedCarlos Mendez
CC-2814.4.6Pharmacokinetics Studies4.8Word2,327BlockedLieselotte van der Berg
CC-3814.4.4Carcinogenicity3.0Word9,570FailedJames O'Brien
CC-4812.6.5Nonclinical Summary3.5HTML14,404In ProgressCarlos Mendez
CC-5814.9.5Pharmacology Studies2.3Word11,710ActiveTomoko Ikeda
CC-6811.6.5Patient Labeling6.4PDF4,698SubmittedCarlos Mendez
CC-7815.1.3Study Reports – Clinical Pharmacology10.6PDF11,067DraftJames O'Brien
CC-8813.8.5Analytical Methods8.3Word3,473ActiveAisha Okonkwo
CC-9814.4.1Pharmacokinetics Studies3.0Word14,101SubmittedSarah Chen
CC-10815.9.5Integrated Summary of Efficacy10.0Word11,803ApprovedMarcus Webb
CC-11815.8.4Integrated Summary of Safety2.3Word6,774ActiveJames O'Brien
CC-12814.7.6Genotoxicity1.7XML3,313OverdueSarah Chen
CC-13812.8.8Quality Overall Summary7.3PDF11,850CompletedCarlos Mendez
CC-14812.1.7Clinical Summary2.8XML10,832DraftTomoko Ikeda
CC-15815.1.8Integrated Summary of Safety11.2XML3,145DraftDmitri Volkov
CC-16812.8.2Quality Overall Summary11.1PDF7,128ApprovedAisha Okonkwo
CC-17813.8.2Analytical Methods8.8Word13,390ApprovedDmitri Volkov
CC-18812.7.2Nonclinical Overview2.2PDF11,987BlockedJames O'Brien
CC-19811.5.9Prescribing Information8.9PDF12,949In ProgressPriya Sharma