Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2025

Month: February

Request Number: A-2024-000858

Request Summary: According to the Health Canada Generic Submissions Under Review (GSUR) List, Health Canada is currently reviewing an Abbreviated New Drug Submission (ANDS) seeking approval of a product containing the medicinal ingredient estradiol which was accepted into review in May 2023. If the Estradiol ANDS has received: a Notice of Deficiency (NOD); a Notice of Non-Compliance (NON); a NOD-Withdrawal (NOD-W); or a NON-Withdrawal (NON-W), provide the month and year that the notice was issued; provide a copy of the correspondence; and provide a copy of any response(s) submitted by the sponsor of the Estradiol ANDS.

Disposition: Disclosed in part

Number of pages: 321

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