Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: September

Request Number: A-2022-001093

Request Summary: The initial cover letter indicating the brand name of the reference drug product and the dosage form of the generic drug subject of the Abbreviated new Drug Submission (ANDS) which was added to Health Canada’s list of “Generic Drug Submissions Under Review” dated 2022-11-10 for the medicinal ingredient sapropterin hydrochloride. The Screening Acceptance Letter from Health Canada to the generic drug manufacturer confirming completion of screening of the Abbreviated New Drug Submissions (ANDS) for sapropterin hydrochloride.

Disposition: Disclosed in part

Number of pages: 2

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