Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: January

Request Number: A-2022-000855

Request Summary: The initial cover letters or any other document for all Abbreviated New Drug Submissions (ANDS) 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 2022-08-11 for the medicinal ingredient rivaroxaban. The Screening Acceptance Letters for all ANDS from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for rivaroxaban which appear in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2022-08-11."

Disposition: Disclosed in part

Number of pages: 31

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