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