Informal Request for ATI Records Previously Released

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

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