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