Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: August

Request Number: A-2022-000160

Request Summary: The Abbreviated New Drug Submission (ANDS) seeking approval of a generic degarelix acetate product (Control No. 245431) received a Notice of Non-Compliance (NON) on August 23, 2021. If the sponsor submitted a Response to the NON: (i) the month and year that the Response was submitted. (ii) a copy of the correspondence.

Disposition: Disclosed in part

Number of pages: 55

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