Dossier DOS-099

Dossier in CTD format, version 6.7.1, for application Roszdravnadzor-2021-0099. The module tree below shows the 5 CTD modules with their component count and status.

Dossier ID
DOS-099
Format
CTD
Version
6.7.1
Status
Completed
Application
Roszdravnadzor-2021-0099
Created
2022-06-22
Updated
2024-02-26
Total Modules
5
Module Tree
ModuleTitleComponentsStatus
1Administrative Information and Prescribing Information7Blocked
2CTD Summaries15Active
3Quality6Completed
4Nonclinical Study Reports10Approved
5Clinical Study Reports6Active
Content Components (showing first 20)
IDSectionTitleVersionFormatWordsStatusOwner
CC-0994.8.4Carcinogenicity2.1PDF3,297DraftNadia Petrova
CC-1994.1.4Pharmacology Studies8.4XML14,116In ProgressNadia Petrova
CC-2994.5.1Pharmacology Studies4.8Word10,489ApprovedDmitri Volkov
CC-3994.9.8Toxicology Studies12.2XML1,571SubmittedAisha Okonkwo
CC-4991.4.4Proposed Conditions of Approval9.7PDF14,141DraftPriya Sharma
CC-5993.6.2Stability Data9.5PDF9,208CompletedMarcus Webb
CC-6993.6.9Drug Substance2.1XML11,881DraftJames O'Brien
CC-7995.7.3Study Reports – Efficacy4.6HTML11,627In ProgressLieselotte van der Berg
CC-8992.8.4Nonclinical Overview2.1PDF3,954SubmittedCarlos Mendez
CC-9991.6.1Cover Letter10.2PDF533ActiveDmitri Volkov
CC-10994.9.2Pharmacokinetics Studies8.1PDF5,466SubmittedCarlos Mendez
CC-11994.1.2Pharmacokinetics Studies5.2HTML7,820FailedMarcus Webb
CC-12991.8.1Application Form7.7Word9,331In ProgressLieselotte van der Berg
CC-13995.3.4Study Reports – Efficacy8.5HTML4,717BlockedNadia Petrova
CC-14993.8.1Analytical Methods7.8PDF3,131FailedAisha Okonkwo
CC-15995.1.3Study Reports – Safety1.0XML9,163CompletedMarcus Webb
CC-16993.1.8Drug Product2.9HTML5,196FailedDmitri Volkov
CC-17995.1.3Study Reports – Clinical Pharmacology9.5PDF14,031SubmittedMarcus Webb
CC-18995.7.6Study Reports – Efficacy9.8XML7,418ApprovedAisha Okonkwo
CC-19992.7.6Nonclinical Overview6.8PDF1,154OverdueLieselotte van der Berg