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Current Location: Home > Label Information of FDA Feedback Help
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Application Type Application No. Drug Name Active Ingredients Action Date Company Label
BLA 761083 HEMLIBRA EMICIZUMAB 2017-11-16 GENENTECH INC View
BLA 761080 2018-07-20 HOSPIRA INC View
BLA 761079 PALYNZIQ PEGVALIASE-PQPZ 2018-05-24 BIOMARIN PHARM View
BLA 761078 BAVENCIO AVELUMAB 2017-05-09 EMD SERONO INC View
BLA 761077 AIMOVIG ERENUMAB-AOOE 2018-05-18 AMGEN INC View
BLA 761075 FULPHILA PEGFILGRASTIM-JMDB 2018-06-04 MYLAN GMBH View
BLA 761074 OGIVRI TRASTUZUMAB-DKST 2017-12-01 MYLAN GMBH View
BLA 761072 IXIFI INFLIXIMAB-QBTX 2017-12-13 PFIZER INC View
BLA 761070 FASENRA BENRALIZUMAB 2017-11-15 ASTRAZENECA AB View
BLA 761069 IMFINZI DURVALUMAB 2018-02-16 ASTRAZENECA UK LTD View
BLA 761069 IMFINZI DURVALUMAB 2017-05-01 ASTRAZENECA UK LTD View
BLA 761068 CRYSVITA BUROSUMAB-TWZA 2018-04-17 ULTRAGENYX PHARM INC View
BLA 761067 ILUMYA TILDRAKIZUMAB-ASMN 2018-03-23 MERCK SHARP DOHME View
BLA 761065 TROGARZO IBALIZUMAB-UIYK 2018-05-31 TAIMED BIOLOGICS USA View
BLA 761065 TROGARZO IBALIZUMAB-UIYK 2018-03-07 TAIMED BIOLOGICS USA View
BLA 761064 RITUXAN HYCELA HYALURONIDASE;RITUXIMAB 2017-06-22 GENENTECH INC View
BLA 761061 TREMFYA GUSELKUMAB 2017-07-13 JANSSEN BIOTECH View
BLA 761060 MYLOTARG GEMTUZUMAB OZOGAMICIN 2018-04-12 WYETH PHARMS INC View
BLA 761060 MYLOTARG GEMTUZUMAB OZOGAMICIN 2017-09-01 WYETH PHARMS INC View
BLA 761058 CYLTEZO ADALIMUMAB-ADBM 2017-08-25 BOEHRINGER INGELHEIM View