Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2025

Month: January

Request Number: A-2024-000014

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 for the medicinal ingredient Ciclesonide. The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submission (ANDS) for Ciclesonide. The strength(s) and dosage form of any and all generic drugs for the medicinal ingredient Ciclesonide. The conditions and the reference product used for the bioequivalence study and any other clinical study of any and all generic drugs for the medicinal ingredient Ciclesonide. The description of the dosage form, and proposed packaging of any and all generic drugs for the Medicinal ingredient Ciclesonide.

Disposition: Disclosed in part

Number of pages: 36

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