EVRF 07/Rev 05/September 2023/BIOWAIVER FOR ADDITIONAL STRENGTH INFORMATION FORM14 DownloadsDownload Now!Size: 69 KB
Read MoreEVRF 74/Rev 1/May 2025/APPLICATION FORM FOR RENEWAL OF PRODUCT REGISTRATIONS13 DownloadsDownload Now!Size: 60 KB
Read MoreEVRF 73/Rev 1/May 2025/MCAZ QUALITY INFORMATION SUMMARY10 DownloadsDownload Now!Size: 106 KB
Read MoreEVRF05/Rev 06 September 2023/BIOPHARMACEUTICS CLASSIFICATION SYSTEM BCS BASED BIOWAIVER INFORMATION FORM9 DownloadsDownload Now!Size: 92 KB
Read MoreEVRF03/REV 4 SEPTEMBER 20203/BIOEQUIVALENCE TRIAL INFORMATION FORM16 DownloadsDownload Now!Size: 108 KB
Read MoreEVRF 79 Rev 0_July 2024-QUALITY OVERALL SUMMARY123 DownloadsDownload Now!Size: 110KB
Read MoreREGISTRATION CERTIFICATE MC16_FORM446 DownloadsDownload Now!
Read MoreAPPLICANT’S SCREENING CHECKLIST FOR REGISTRATION OF HUMAN BIOLOGICAL MEDICINES753 DownloadsDownload Now!Size: 297KB
Read MoreEVRF 72 Rev 0_December 2022 Document Submission Checklist878 DownloadsDownload Now!Size: 2MBPublished: January 4, 2023
Read MoreEVRF 44-Request for a Status Update587 DownloadsDownload Now!Size: 1MB
Read More