Organization: Health Canada
Year: 2023
Month: July
Request Number: A-2023-000014
Request Summary: The initial cover letter and 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 2023-03-24 for the medicinal ingredient Levetiracetam. The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for Levetiracetam. The strength (s) and dosage form of any and all generic drugs in Health Canada’s list of “Generic Drug Submissions for the medicinal ingredient Levetiracetam.
Disposition: Disclosed in part
Number of pages: 127