Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: July

Request Number: A-2022-001492

Request Summary: The initial cover letters 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 2023-02-24 for the medicinal ingredient tiotopium bromide monohydrate. The Screening Acceptance Letters from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for tiotropium bromide monohydrate which appears in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2023-02-24.

Disposition: Disclosed in part

Number of pages: 10

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