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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
761262 BLA SKYRIZI RISANKIZUMAB-RZAA INJECTABLE;INTRAVENOUS 2022-06-16 ABBVIE INC
761261 BLA XENPOZYME OLIPUDASE ALFA-RPCP INJECTABLE;INJECTION 2022-08-31 GENZYME CORP
761244 BLA SPEVIGO SPESOLIMAB-SBZO INJECTABLE;INTRAVENOUS 2022-09-01 BOEHRINGER INGELHEIM PHARMACEUTICALS INC
761235 BLA VABYSMO FARICIMAB-SVOA INJECTABLE; INTRAVITREAL 2022-01-28 GENENTECH INC
761234 BLA OPDUALAG NIVOLUMAB;RELATLIMAB-RMBW SOLUTION;INTRAVENOUS 2022-03-18 BRISTOL MYERS SQUIBB
761231 BLA ALYMSYS BEVACIZUMAB-MALY INJECTABLE;INJECTION 2022-04-13 AMNEAL PHARMS LLC
761228 BLA KIMMTRAK TEBENTAFUSP-TEBN INJECTABLE;INJECTION 2022-01-25 IMMUNOCORE LTD
761224 BLA TEZSPIRE TEZEPELUMAB-EKKO SOLUTION;SUBCUTANEOUS 2021-12-17 ASTRAZENECA AB
761223 BLA JEMPERLI DOSTARLIMAB-GXLY INJECTABLE;INJECTION 2021-08-17 GLAXOSMITHKLINE LLC
761216 BLA YUSIMRY ADALIMUMAB-AQVH INJECTABLE;INJECTION 2021-12-17 COHERUS BIOSCIENCES INC
761215 BLA REZVOGLAR INSULIN GLARGINE-AGLR INJECTABLE;INJECTION 2021-12-17 ELI LILLY CO
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
761197 BLA SUSVIMO RANIBIZUMAB SOLUTION;INJECTION 2021-10-22 GENENTECH INC
761196 BLA ZYNLONTA LONCASTUXIMAB TESIRINE-LPYL INJECTABLE;INJECTION 2021-04-23 ADC Therapeutics SA
761195 BLA VYVGART EFGARTIGIMOD ALFA INJECTABLE;INJECTION 2021-12-17 ARGENX BV
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