Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2024

Month: March

Request Number: A-2023-001020

Request Summary: All records relating to the determinations that: The active ingredient of Teva-Teriparatide Injection is classified as a pharmaceutical drug substance rather than a biologic. In vivo bioequivalence studies were not required for the Teva-Teriparatide Abbreviated New Drug Submission (ANDS).

Disposition: Disclosed in part

Number of pages: 972

Date modified: