Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2022

Month: August

Request Number: A-2021-001236

Request Summary: The Health Canada Generic Submissions Under Review List, an Abbreviated New Drug Submission (ANDS) for degarelix acetate was submitted on or after October 1, 2018. Please provide the generic product’s full composition, including all data regarding the list of ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients, as described in paragraph C.08.002(2)(c) of the Food and Drug Regulations and as required by section 2.3.P.1 of the Quality Overall Summary – Chemical Entities (New Drug Submissions/Abbreviated New Drug Submissions) (QOS-CE (NDS/ANDS)).

Disposition: Disclosed in part

Number of pages: 225

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