MCAZ

EVRF 07/Rev 05/September 2023/BIOWAIVER FOR ADDITIONAL STRENGTH INFORMATION FORM
EVRF 07/Rev 05/September 2023/BIOWAIVER FOR ADDITIONAL STRENGTH INFORMATION FORM
Size: 69 KB
EVRF 74/Rev 1/May 2025/APPLICATION FORM FOR RENEWAL OF PRODUCT REGISTRATIONS
EVRF 74/Rev 1/May 2025/APPLICATION FORM FOR RENEWAL OF PRODUCT REGISTRATIONS
Size: 60 KB
EVRF 73/Rev 1/May 2025/MCAZ QUALITY INFORMATION SUMMARY
EVRF 73/Rev 1/May 2025/MCAZ QUALITY INFORMATION SUMMARY
Size: 106 KB
EVRF05/Rev 06 September 2023/BIOPHARMACEUTICS CLASSIFICATION SYSTEM BCS BASED BIOWAIVER INFORMATION FORM
EVRF05/Rev 06 September 2023/BIOPHARMACEUTICS CLASSIFICATION SYSTEM BCS BASED BIOWAIVER INFORMATION FORM
Size: 92 KB
EVRF03/REV 4 SEPTEMBER 20203/BIOEQUIVALENCE TRIAL INFORMATION FORM
EVRF03/REV 4 SEPTEMBER 20203/BIOEQUIVALENCE TRIAL INFORMATION FORM
Size: 108 KB
EVRF 79 Rev 0_July 2024-QUALITY OVERALL SUMMARY
EVRF 79 Rev 0_July 2024-QUALITY OVERALL SUMMARY
Size: 110KB
REGISTRATION CERTIFICATE MC16_FORM
REGISTRATION CERTIFICATE MC16_FORM
APPLICANT’S SCREENING CHECKLIST FOR REGISTRATION OF HUMAN BIOLOGICAL MEDICINES
APPLICANT’S SCREENING CHECKLIST FOR REGISTRATION OF HUMAN BIOLOGICAL MEDICINES
Size: 297KB
EVRF 72 Rev 0_December 2022 Document Submission Checklist
EVRF 72 Rev 0_December 2022 Document Submission Checklist
Size: 2MB
Published: January 4, 2023
EVRF 44-Request for a Status Update
EVRF 44-Request for a Status Update
Size: 1MB
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