Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2024

Month: July

Request Number: A-2023-000638

Request Summary: The initial cover letter(s) indicating the brand name of the reference drug product and the dosage form of the generic drug in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2022-06-22 for the medicinal ingredient mesalazine. The Screening Acceptance Letter(s) from Health Canada to the generic drug manufacturer confirming completion of screening of the drug mesalazine which appears in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2022-06-22. Section 1.0.7 “Note to the Reviewer” (Module 1.0.7) from the generic drug manufacturer of the drug submission for mesalazine which appears in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2022-06-22.

Disposition: Disclosed in part

Number of pages: 4

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