Organization: Health Canada
Year: 2023
Month: April
Request Number: A-2019-000453
Request Summary: Records relating to the approval of Apo-Hydromorphone controlled release capsules; from Modules 1 and 5, specifically: Section 1.4.2 Comprehensive Summary: Bioequivalence and Section 5.2 Tabular Listing of all Clinical Studies, including any correspondence or sequences that relate to these sections.
Disposition: Disclosed in part
Number of pages: 197