Organization: Health Canada
Year: 2023
Month: January
Request Number: A-2022-000991
Request Summary: The initial cover letter 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 bupivacaine hydrochloride. The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for bupivacaine hydrochloride which appears in Health Canada’s list of “Generic Drug Submissions Under Review” dated 2022-10-20.
Disposition: Disclosed in part
Number of pages: 3