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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
761181 BLA EVKEEZA EVINACUMAB-DGNB SOLUTION; INJECTION 2021-02-11 REGENERON PHARMACEUTICALS
761181 BLA EVKEEZA EVINACUMAB-DGNB SOLUTION; INJECTION 2021-02-11 REGENERON PHARMACEUTICALS
761172 BLA EBANGA ANSUVIMAB-ZYKL POWDER;IV (INFUSION) 2020-12-21 RIDGEBACK BIOTHERAPEUTICS
761171 BLA DANYELZA NAXITAMAB-GQGK SOLUTION;INTRAVENOUS 2020-11-25 Y-MABS THERAPEUTICS INC
761170 BLA PHESGO PERTUZUMAB;TRASTUZUMAB;HYALURONIDASE-ZZXF INJECTABLE;SUBCUTANEOUS 2020-06-29 GENENTECH INC
761169 BLA INMAZEB ATOLTIVIMAB; ODESIVIMAB; MAFTIVIMAB SOLUTION; INJECTION 2020-10-14 REGENERON PHARMACEUTICALS
761163 BLA Monjuvi (tafasitamab-cxix) for injection TAFASITAMAB-CXIX INJECTABLE;INJECTION 2020-07-31 MORPHOSYS US INC
761158 BLA BLENREP BELANTAMAB MAFODOTIN-BLMF INJECTABLE;INTRAVENOUS 2020-08-05 GLAXOSMITHKLINE
761156 BLA SOGROYA SOMAPACITAN-BECO SOLUTION;SUBCUTANEOUS 2020-08-28 NOVO NORDISK INC
761154 BLA HULIO ADALIMUMAB-FKJP INJECTABLE;INJECTION 2020-07-06 MYLAN PHARMS INC
761150 BLA MARGENZA MARGETUXIMAB-CMKB INJECTABLE;INJECTION 2020-12-16 MACROGENICS INC
761149 BLA ENSPRYNG SATRALIZUMAB INJECTABLE;INJECTION 2020-08-14 GENENTECH
761146 BLA QWO COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES INJECTABLE;INJECTION 2020-07-06 ENDO GLOBAL AESTHETICS LTD
761145 BLA DARZALEX FASPRO DARATUMUMAB;HYALURONIDASE-FIHJ INJECTABLE;INJECTION 2020-05-01 JANSSEN BIOTECH
761143 BLA TEPEZZA TEPROTUMUMAB-TRBW INJECTABLE;INJECTION 2020-01-21 HORIZON THERAPEUTICS IRELAND
761142 BLA UPLIZNA INEBILIZUMAB-CDON INJECTABLE;INJECTION 2020-06-11 VIELA BIO
761140 BLA RIABNI RITUXIMAB-ARRX INJECTABLE;INJECTION 2020-12-17 AMGEN INC
761139 BLA ENHERTU FAM-TRASTUZUMAB DERUXTECAN-NXKI INJECTABLE;INJECTION 2019-12-20 DAIICHI SANKYO
761137 BLA PADCEV ENFORTUMAB VEDOTIN-EJFV INJECTABLE;INJECTION 2019-12-18 ASTELLAS
761137 BLA PADCEV ENFORTUMAB VEDOTIN-EJFV INJECTABLE;INJECTION 2019-12-18 ASTELLAS