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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