Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2024

Month: September

Request Number: A-2024-000256

Request Summary: The labels for all package types for all strengths or combinations of strengths of the final dosage forms which were included in the initial filing of the Abbreviated New Drug Submission (ANDS) for Tolvaptan from which was accepted into review in November 2023 and was included in the list of Generic submissions under review dated 2024-05-23.

Disposition: Disclosed in part

Number of pages: 17

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Please note To the extent possible, the institution will return the requested records in the format selected, but it may not be able to accommodate all electronic formats due to size limitations.
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