Organization: Health Canada
Year: 2023
Month: April
Request Number: A-2023-000015
Request Summary: All acknowledgment letters issued by Health Canada confirming receipt of Abbreviated New Drug Submissions (ANDS) for a drug containing Ivacaftor as medicinal ingredient. The initial cover letter indicating the brand name of the reference drug product and the dosage form of the generic drug containing Ivacaftor as medicinal ingredient. The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for the generic drug containing Ivacaftor as medicinal ingredient. The strength (s) and dosage form of any and all generic drugs containing Ivacaftor as medicinal ingredient.
Disposition: No records exist
Number of pages: 0