Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: October

Request Number: A-2022-000463

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 2022-06-22 for the medicinal ingredient tolvaptan. The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for tolvaptan 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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