Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2025

Month: February

Request Number: A-2023-000378

Request Summary: The initial cover letter and any other document 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 2023-06-14 for the medicinal ingredient Metformin hydrochloride; The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for Metformin hydrochloride which appears in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-06-14; The strength (s) and dosage form of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-06-14 for the medicinal ingredient Metformin hydrochloride; 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 2023-06-14 for the medicinal ingredient Metformin hydrochloride.

Disposition: Disclosed in part

Number of pages: 585

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