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