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 |