美国FDA生物制品紫皮书数据库（U.S. FDA Purple Book: Database of Licensed Biological Products）- 药物在线

商品名	申请号	产品号	BLA类型	非专利名称	剂型	给药途径	规格/剂量	产品形式	批准日期	申请人	市场状态	许可证状态	参考产品非专利名称	参考产品专利名称
Poteligeo	761051	001	351(a)	mogamulizumab-kpkc	Injection	Intravenous	20MG/5ML (4MG/ML)	Single-Dose Vial	2018/08/08	Kyowa Kirin, Inc.	Rx	Licensed	N/A	N/A
Panzyga	125587	001	351(a)	Immune Globulin Intravenous (Human)-ifas	Injection	Intravenous	1G ML	Single-Use Bottle	2018/08/02	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Panzyga	125587	002	351(a)	Immune Globulin Intravenous (Human)-ifas	Injection	Intravenous	2.5G ML	Single-Use Bottle	2018/08/02	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Panzyga	125587	003	351(a)	Immune Globulin Intravenous (Human)-ifas	Injection	Intravenous	30 G ML	Single-Use Bottle	2018/08/02	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Panzyga	125587	004	351(a)	Immune Globulin Intravenous (Human)-ifas	Injection	Intravenous	20G ML	Single-Use Bottle	2018/08/02	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Panzyga	125587	005	351(a)	Immune Globulin Intravenous (Human)-ifas	Injection	Intravenous	10G ML	Single-Use Bottle	2018/08/02	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Panzyga	125587	006	351(a)	Immune Globulin Intravenous (Human)-ifas	Injection	Intravenous	5G ML	Single-Use Bottle	2018/08/02	Octapharma Pharmazeutika Produktionsges.m.b.H.	Rx	Licensed		N/A
Granix	125294	003	351(a)	tbo-filgrastim	Injection	Subcutaneous	300MCG/1ML	Single-Dose Vial	2018/07/31	UAB Teva Baltics	Rx	Licensed	N/A	N/A
Granix	125294	004	351(a)	tbo-filgrastim	Injection	Subcutaneous	480MCG/1.6ML	Single-Dose Vial	2018/07/31	UAB Teva Baltics	Disc	Licensed	N/A	N/A
Nivestym	761080	001	351(k) Biosimilar	filgrastim-aafi	Injection	Intravenous, Subcutaneous	300MCG/ML	Single-Dose Vial	2018/07/20	Hospira Inc., a Pfizer Company	Rx	Licensed	filgrastim	Neupogen
Nivestym	761080	002	351(k) Biosimilar	filgrastim-aafi	Injection	Intravenous, Subcutaneous	480MCG/1.6ML	Single-Dose Vial	2018/07/20	Hospira Inc., a Pfizer Company	Rx	Licensed	filgrastim	Neupogen
Nivestym	761080	003	351(k) Biosimilar	filgrastim-aafi	Injection	Subcutaneous	300MCG/0.5ML	Pre-Filled Syringe	2018/07/20	Hospira Inc., a Pfizer Company	Rx	Licensed	filgrastim	Neupogen
Nivestym	761080	004	351(k) Biosimilar	filgrastim-aafi	Injection	Subcutaneous	480MCG/0.8ML	Pre-Filled Syringe	2018/07/20	Hospira Inc., a Pfizer Company	Rx	Licensed	filgrastim	Neupogen
Cyltezo	761058	002	351(k) Interchangeable	adalimumab-adbm	Injection	Subcutaneous	20MG/0.4ML	Pre-Filled Syringe	2018/07/13	Boehringer Ingelheim Pharmaceuticals, Inc.	Rx	Licensed	adalimumab	Humira
	125657	001	351(a)	Hematopoietic Progenitor Cells, Cord (HPC-C)	Injection	Intravenous	2.5X10E7/KG CELL/ML	Bag	2018/06/21	MD Anderson Cord Blood Bank	Rx	Licensed		N/A
Albuminex	125644	001	351(a)	Albumin (Human)-kjda	Solution	Intravenous	12.5G/50ML	Single-Dose Vial	2018/06/19	Bio Products Laboratory Limited	Rx	Licensed		N/A
Albuminex	125644	002	351(a)	Albumin (Human)-kjda	Solution	Intravenous	25G/100ML	Single-Dose Vial	2018/06/19	Bio Products Laboratory Limited	Rx	Licensed		N/A
Albuminex	125644	003	351(a)	Albumin (Human)-kjda	Solution	Intravenous	12.5G/250ML	Single-Dose Vial	2018/06/19	Bio Products Laboratory Limited	Rx	Licensed		N/A
Albuminex	125644	004	351(a)	Albumin (Human)-kjda	Solution	Intravenous	25G/500ML	Single-Dose Vial	2018/06/19	Bio Products Laboratory Limited	Rx	Licensed		N/A
Fulphila	761075	001	351(k) Biosimilar	pegfilgrastim-jmdb	Injection	Subcutaneous	6MG/0.6ML	Pre-Filled Syringe	2018/06/04	Biocon Biologics Inc.	Rx	Licensed	pegfilgrastim	Neulasta

药品商品名或专利药名Proprietary (Brand) Name
药品通用名或非专利名称Nonproprietary (Proper) Name
药品申请号BLA Number
产品号Product Number
剂型Dosage Form
给药途径Route of Administration
产品形式Product Presentation
药品规格或剂量Strength
药品注册申请人Applicant
参考产品非专利名称Reference Product Proper Name
参考产品专利名称Reference Product Proprietary Name
BLA类型BLA Type
药品的市场状态Marketing Status
许可证号License Number
许可证状态Licensure
产品批准日期Approval Date	-