Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: September

Request Number: A-2023-000441

Request Summary: The initial cover letter 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 2023-06-23 for the medicinal ingredient Mesalazine. The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for Mesalazine which appears in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-06-23. The strength (s) and dosage form of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-06-23 for the medicinal ingredient Mesalazine. The conditions and the reference product used for the bioequivalence study of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-06-23 for the medicinal ingredient Mesalazine.

Disposition: Disclosed in part

Number of pages: 115

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