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Application Number Application Type Drug Name Active Ingredients Dosage Form/Route Approval Date Company
761083 BLA HEMLIBRA EMICIZUMAB INJECTABLE;INJECTION 2017-11-16 GENENTECH INC
761083 BLA HEMLIBRA EMICIZUMAB INJECTABLE;INJECTION 2017-11-16 GENENTECH INC
761083 BLA HEMLIBRA EMICIZUMAB INJECTABLE;INJECTION 2017-11-16 GENENTECH INC
761083 BLA HEMLIBRA EMICIZUMAB INJECTABLE;INJECTION 2017-11-16 GENENTECH INC
761078 BLA BAVENCIO AVELUMAB INJECTABLE;INTRAVENOUS 2017-05-09 EMD SERONO INC
761074 BLA OGIVRI TRASTUZUMAB-DKST INJECTABLE;INJECTION 2017-12-01 MYLAN GMBH
761072 BLA IXIFI INFLIXIMAB-QBTX INJECTABLE;INJECTION 2017-12-13 PFIZER INC
761070 BLA FASENRA BENRALIZUMAB INJECTABLE;INJECTION 2017-11-14 ASTRAZENECA AB
761069 BLA IMFINZI DURVALUMAB INJECTABLE;INJECTION 2017-05-01 ASTRAZENECA UK LTD
761068 BLA CRYSVITA BUROSUMAB-TWZA INJECTABLE;INJECTION 2018-04-17 ULTRAGENYX PHARM INC
761067 BLA ILUMYA TILDRAKIZUMAB-ASMN INJECTABLE;INJECTION 2018-03-20 MERCK SHARP DOHME
761065 BLA TROGARZO IBALIZUMAB-UIYK INJECTABLE;INJECTION 2018-03-06 TAIMED BIOLOGICS USA
761064 BLA RITUXAN HYCELA HYALURONIDASE;RITUXIMAB INJECTABLE;INJECTION 2017-06-22 GENENTECH INC
761064 BLA RITUXAN HYCELA HYALURONIDASE;RITUXIMAB INJECTABLE;INJECTION 2017-06-22 GENENTECH INC
761061 BLA TREMFYA GUSELKUMAB INJECTABLE;INJECTION 2017-07-13 JANSSEN BIOTECH
761060 BLA MYLOTARG GEMTUZUMAB OZOGAMICIN VIAL;SINGLE-DOSE 2017-09-01 WYETH PHARMS INC
761058 BLA CYLTEZO ADALIMUMAB-ADBM INJECTABLE;INJECTION 2017-08-25 BOEHRINGER INGELHEIM
761055 BLA DUPIXENT DUPILUMAB INJECTABLE; INJECTION 2017-03-28 REGENERON PHARMACEUTICALS
761054 BLA RENFLEXIS INFLIXIMAB-ABDA INJECTABLE;INJECTION 2017-04-21 SAMSUNG BIOEPSIS CO LTD
761053 BLA OCREVUS OCRELIZUMAB INJECTABLE;INJECTION 2017-03-28 GENENTECH INC