Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2024

Month: January

Request Number: A-2022-000909

Request Summary: The most current status of the Abbreviated New Drug Submission (ANDS) seeking approval of a generic degarelix acetate product (Control No. 245431), which last received a Screening Acceptance Letter from Health Canada on March 7, 2022 for the sponsor’s Response to a Notice of Non-Compliance, dated August 23, 2021.

Disposition: Disclosed in part

Number of pages: 9

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