Dossier DOS-077

Dossier in eCTD format, version 3.9.9, for application SFDA-2023-0077. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-077
Format
eCTD
Version
3.9.9
Status
Approved
Application
SFDA-2023-0077
Created
2022-07-06
Updated
2023-04-27
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information4Submitted
2CTD Summaries5Pending
3Quality6Overdue
4Nonclinical Study Reports7Approved
5Clinical Study Reports7Failed
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0772.2.4Clinical Summary1.9XML2,645CompletedCarlos Mendez
CC-1772.9.8Clinical Overview4.7XML12,630SubmittedMarcus Webb
CC-2774.7.6Carcinogenicity7.3PDF2,981CompletedLieselotte van der Berg
CC-3771.7.6Application Form5.7HTML9,631OverduePriya Sharma
CC-4773.2.2Appendices5.7PDF11,038FailedCarlos Mendez
CC-5771.1.6Patient Labeling5.4PDF1,322OverdueAisha Okonkwo
CC-6774.6.3Toxicology Studies11.4HTML12,735BlockedCarlos Mendez
CC-7775.2.3Study Reports – Clinical Pharmacology4.7Word10,265PendingPriya Sharma
CC-8773.4.8Container Closure System10.7PDF4,659FailedLieselotte van der Berg
CC-9775.1.9Study Reports – Clinical Pharmacology3.1XML12,517In ProgressLieselotte van der Berg
CC-10772.4.9Clinical Summary5.6PDF9,849ActiveLieselotte van der Berg
CC-11773.7.6Stability Data10.4XML723ActiveNadia Petrova
CC-12771.8.5Patient Labeling6.5Word6,094DraftPriya Sharma
CC-13771.7.7Prescribing Information9.2XML14,759SubmittedMarcus Webb
CC-14771.5.6Prescribing Information1.3Word6,899OverduePriya Sharma
CC-15771.6.6Application Form6.5XML10,567DraftSarah Chen
CC-16773.9.6Analytical Methods9.0PDF10,578DraftAisha Okonkwo
CC-17775.5.4Study Reports – Clinical Pharmacology8.5HTML9,941In ProgressJames O'Brien
CC-18771.8.4Application Form3.4PDF14,401ActiveNadia Petrova
CC-19773.5.5Drug Substance5.2XML979In ProgressCarlos Mendez