Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2023

Month: July

Request Number: A-2022-000450

Request Summary: Health Canada is currently reviewing an Abbreviated New Drug Submission (ANDS) seeking approval of a product containing the medicinal ingredient desmopressin acetate. The dosage form, and in particular whether the dosage form is either a tablet or an orally disintegrating tablet, in which it is proposed that the new drug in the Desmopressin ANDS be sold, as described in paragraph C.08.002(2)(l) of the Food and Drug Regulations.

Disposition: Disclosed in part

Number of pages: 3

Date modified: