Dossier DOS-012

Dossier in CTD format, version 1.7.7, for application HSA-2023-0012. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-012
Format
CTD
Version
1.7.7
Status
Draft
Application
HSA-2023-0012
Created
2022-01-22
Updated
2024-01-30
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information15Completed
2CTD Summaries5Approved
3Quality13Submitted
4Nonclinical Study Reports12Active
5Clinical Study Reports8In Progress
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0125.8.1Study Reports – Efficacy7.0PDF7,126CompletedTomoko Ikeda
CC-1122.8.1Quality Overall Summary3.4Word11,087SubmittedSarah Chen
CC-2123.6.5Drug Substance2.8PDF4,790OverdueNadia Petrova
CC-3124.7.9Pharmacokinetics Studies4.1HTML14,064In ProgressJames O'Brien
CC-4121.7.1Prescribing Information12.5HTML8,813CompletedDmitri Volkov
CC-5121.9.4Prescribing Information5.9HTML8,990SubmittedPriya Sharma
CC-6125.2.2Integrated Summary of Safety2.8PDF13,292ActiveNadia Petrova
CC-7122.9.4Nonclinical Overview9.0HTML3,737ApprovedMarcus Webb
CC-8123.8.8Drug Substance8.0Word13,630In ProgressLieselotte van der Berg
CC-9123.3.3Manufacturing Process2.3Word12,460OverdueJames O'Brien
CC-10125.6.5Study Reports – Clinical Pharmacology6.5Word4,040PendingMarcus Webb
CC-11123.8.2Container Closure System1.2PDF1,832BlockedDmitri Volkov
CC-12121.7.4Cover Letter11.5PDF4,947SubmittedAisha Okonkwo
CC-13124.5.5Pharmacology Studies1.7XML13,331CompletedJames O'Brien
CC-14121.8.7Prescribing Information3.4PDF6,248SubmittedNadia Petrova
CC-15124.1.6Carcinogenicity9.4PDF13,988OverdueSarah Chen
CC-16122.2.6Clinical Summary7.0HTML3,258FailedJames O'Brien
CC-17124.3.3Pharmacology Studies12.0XML1,120FailedTomoko Ikeda
CC-18123.9.8Drug Substance4.1HTML14,901PendingCarlos Mendez
CC-19121.3.1Cover Letter11.5Word12,313ActiveCarlos Mendez