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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
761358 BLA ZYMFENTRA INFLIXIMAB-DYYB INJECTABLE;INJECTION CELLTRION
761355 BLA EYLEA HD AFLIBERCEPT INJECTABLE;INJECTION REGENERON PHARMACEUTICALS
761354 BLA TOFIDENCE TOCILIZUMAB-BAVI INJECTABLE;INJECTION BIOGEN MA
761349 BLA COSENTYX SECUKINUMAB INJECTABLE;INJECTION NOVARTIS PHARMS CORP
761345 BLA ELREXFIO ELRANATAMAB SOLUTION;INJECTION PFIZER INC
761342 BLA TALVEY TALQUETAMAB-TGVS INJECTABLE;INJECTION JANSSEN BIOTECH
761339 BLA VEOPOZ POZELIMAB-BBFG INJECTABLE;INJECTION REGENERON PHARMACEUTICALS
761334 BLA ZYNYZ RETIFANLIMAB-DLWR INJECTABLE;INTRAVENOUS 2023-03-22 INCYTE CORP
761331 BLA WEZLANA USTEKINUMAB-AUUB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS AMGEN INC
761328 BLA BEYFORTUS NIRSEVIMAB-ALIP INJECTABLE;INJECTION ASTRAZENECA AB
761324 BLA EPKINLY EPCORITAMAB-BYSP INJECTABLE;SUBCUTANEOUS GENMAB US, INC.
761322 BLA TYRUKO NATALIZUMAB-SZTN INJECTABLE;INJECTION SANDOZ INC
761310 BLA ELAHERE MIRVETUXIMAB SORAVTANSINE-GYNX INJECTABLE;INJECTION 2022-11-14 IMMUNOGEN INC
761309 BLA COLUMVI GLOFITAMAB-GXBM INJECTABLE;INJECTION GENENTECH INC
761304 BLA VYVGART HYTRULO EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC INJECTABLE;INJECTION ARGENX BV
761299 BLA SIMLANDI ADALIMUMAB-RYVK INJECTABLE;INJECTION ALVOTECH USA INC
761291 BLA TECVAYLI TECLISTAMAB-CQYV INJECTABLE;INJECTION 2022-10-25 JANSSEN BIOTECH
761289 BLA IMJUDO TREMELIMUMAB-ACTL INJECTABLE;INTRAVENOUS 2022-10-21 ASTRAZENECA AB
761286 BLA RYSTIGGO ROZANOLIXIZUMAB-NOLI INJECTABLE;SUBCUTANEOUS UCB INC
761285 BLA WEZLANA USTEKINUMAB-AUUB INJECTABLE;INTRAVENOUS, SUBCUTANEOUS AMGEN INC