Application Number | Application Type | Drug Name | Active Ingredients | Dosage Form/Route | Approval Date | Company |
---|---|---|---|---|---|---|
761173 | BLA | STIMUFEND | PEGFILGRASTIM-FPGK | SOLUTION; INJECTION | 2022-09-01 | FRESENIUS KABI USA |
761111 | BLA | NYVEPRIA | PEGFILGRASTIM-APGF | INJECTABLE;INJECTION | 2020-06-10 | HOSPIRA INC |
761084 | BLA | FYLNETRA | PEGFILGRASTIM-PBBK | INJECTABLE;INJECTION | 2022-05-26 | KASHIV BIOSCIENCES LLC |
761082 | BLA | RELEUKO | FILGRASTIM-AYOW | SOLUTION;INTRAVENOUS, SUBCUTANEOUS | 2022-02-25 | KASHIV BIOSCIENCES LLC |
761080 | BLA | NIVESTYM | FILGRASTIM-AAFI | VIAL;SINGLE-DOSE | 2018-07-20 | HOSPIRA INC |
761075 | BLA | FULPHILA | PEGFILGRASTIM-JMDB | INJECTABLE;INJECTION | 2018-06-04 | MYLAN GMBH |
761045 | BLA | ZIEXTENZO | PEGFILGRASTIM-BMEZ | INJECTABLE;INJECTION | 2019-11-04 | SANDOZ INC |
761039 | BLA | UDENYCA | PEGFILGRASTIM-CBQV | INJECTABLE;INJECTION | 2018-11-02 | COHERUS BIOSCIENCES INC |
125553 | BLA | ZARXIO | FILGRASTIM-SNDZ | INJECTABLE;INJECTION | 2015-03-06 | SANDOZ INC |
125294 | BLA | GRANIX | TBO-FILGRASTIM | INJECTABLE; INJECTION | 2012-08-29 | SICOR BIOTECH |
125031 | BLA | NEULASTA | PEGFILGRASTIM | SYRINGE | 2002-01-31 | AMGEN |
103353 | BLA | NEUPOGEN | FILGRASTIM | VIAL | 1991-02-20 | AMGEN |