Organization: Health Canada
Year: 2023
Month: April
Request Number: A-2022-001042
Request Summary: Submission components for Polymyxin B for Injection United States Pharmacopeia (USP) Drug Identification Number (DIN) 02375893 Submission control 143565: Cover Letter; M1.4.2 Comprehensive Summary Bioequivalence; M1.6.1 Comparative Bioavailability; M2.1 Table of Contents; M2.2 Introduction; and Health Canada Reviewer notes. Please include only electronic documents.
Disposition: Disclosed in part
Number of pages: 1236