Organization: Health Canada
Year: 2024
Month: September
Request Number: A-2023-001361
Request Summary: With respect to drug submission for aripiprazole which appears in the list of “Generic Drug Submissions Under Review” dated 2024-01-19, the initial cover letter(s) indicating the brand name of the reference drug product and the dosage form of the generic drug, the Screening Acceptance Letter(s) from Health Canada to the generic drug manufacturer confirming completion of screening of the drug submissions, and section 1.0.7 “Note to the Reviewer” (Module 1.0.7) from the generic drug manufacturer.
Disposition: Disclosed in part
Number of pages: 4