Organization: Health Canada
Year: 2024
Month: September
Request Number: A-2024-000721
Request Summary: Please provide review reports and records of discussion of biowaiver requirements and bioequivalence for Cytex Pharmaceuticals Inc.’s “PROGESTERONE INJ” (Drug Identification Number (DIN) 01977652). The product was first marketed in December 1992.
Disposition: No records exist
Number of pages: 0