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