Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2024

Month: January

Request Number: A-2023-000916

Request Summary: The Abbreviated New Drug Submission (ANDS) no. 262177 filed by JAMP Pharma Corporation for nintedanib or nintedanib esilate, copies of any Notice of Deficiency (NOD), Notice of Non-Compliance (NON), NOD-Withdrawal (NOD-W), or NON-Withdrawal (NON-W), and any correspondence from or to JAMP Pharma regarding withdrawal or cancellation of the 100 mg strength of its nintedanib product from the ANDS.

Disposition: Disclosed in part

Number of pages: 16

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