Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: June

Request Number: A-2023-000048

Request Summary: The initial cover letter indicating the brand name of the reference drug product and the dosage form of any generic submission (ANDS) having 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. The strength (s) and dosage form of any and all generic drugs having the medicinal ingredient Tolvaptan. The Canadian Reference product (strength (s) and dosage form) used to support any generic submission (ANDS) having the medicinal ingredient Tolvaptan.

Disposition: Disclosed in part

Number of pages: 4

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