Organization: Health Canada
Year: 2023
Month: March
Request Number: A-2022-000992
Request Summary: The initial cover letter or any other document indicating the brand name of the reference drug product and the dosage form of the generic drug in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2022-10-20 for the medicinal ingredient mirabegron. The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for mirabegron which appears in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2022-10-20.
Disposition: Disclosed in part
Number of pages: 15