Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2024

Month: August

Request Number: A-2024-000258

Request Summary: The cover letter which accompanied the initial filing of the Abbreviated New Drug Submission (ANDS) for Tolvaptan which was accepted into review in November 2023 and, is included in the list of Generic submissions under review dated 2024-05-23 and the corresponding Sponsor Attestation Checklist for ANDS.

Disposition: Disclosed in part

Number of pages: 34

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