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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
761223 BLA JEMPERLI DOSTARLIMAB-GXLY INJECTABLE;INJECTION 2021-08-17 GLAXOSMITHKLINE LLC
761210 BLA RYBREVANT AMIVANTAMAB-VMJW INJECTABLE;INJECTION 2021-05-21 JANSSEN BIOTECH
761208 BLA TIVDAK TISOTUMAB VEDOTIN-TFTV INJECTABLE;INJECTION 2021-09-20 SEAGEN
761202 BLA BYOOVIZ RANIBIZUMAB-NUNA INJECTABLE;INJECTION 2021-09-17 SAMSUNG BIOEPIS CO LTD
761201 BLA SEMGLEE INSULIN GLARGINE-YFGN INJECTABLE;INJECTION 2021-07-28 MYLAN PHARMS INC
761196 BLA ZYNLONTA LONCASTUXIMAB TESIRINE-LPYL INJECTABLE;INJECTION 2021-04-23 ADC Therapeutics SA
761194 BLA NEXVIAZYME AVALGLUCOSIDASE ALFA-NGPT INJECTABLE;INJECTION 2021-08-06 GENZYME CORP
761181 BLA EVKEEZA EVINACUMAB-DGNB SOLUTION; INJECTION 2021-02-11 REGENERON PHARMACEUTICALS
761179 BLA RYLAZE ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN INJECTABLE;INTRAMUSCULAR 2021-06-30 JAZZ PHARMS
761178 BLA ADUHELM ADUCANUMAB-AVWA INJECTABLE;INJECTION 2021-06-07 BIOGEN INC
761177 BLA SKYTROFA LONAPEGSOMATROPIN-TCGD INJECTABLE;INJECTION 2021-08-25 ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S
761174 BLA JEMPERLI DOSTARLIMAB-GXLY INJECTABLE;INJECTION 2021-04-22 GLAXOSMITHKLINE
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 JAZZ PHARMACEUTICALS IRELAND LIMITED
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