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	参考产品专利名称
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5	101138	002	351(a)	Albumin (Human)	For Injection	Intravenous	25G/100ML	Single-Dose Vial	1942/10/21	Grifols Therapeutics LLC	Rx	Licensed	N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5	101138	003	351(a)	Albumin (Human)	For Injection	Intravenous	20G/100ML	Single-Dose Vial	1942/10/21	Grifols Therapeutics LLC	Rx	Licensed	N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5	101138	004	351(a)	Albumin (Human)	For Injection	Intravenous	10G/50ML	Single-Dose Vial	1942/10/21	Grifols Therapeutics LLC	Rx	Licensed	N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5	101138	005	351(a)	Albumin (Human)	For Injection	Intravenous	12.5G/50ML	Single-Dose Vial	1942/10/21	Grifols Therapeutics LLC	Rx	Licensed	N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5	101138	006	351(a)	Albumin (Human)	For Injection	Intravenous	5G/20ML	Single-Dose Vial	1942/10/21	Grifols Therapeutics LLC	Rx	Licensed	N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5	101138	007	351(a)	Albumin (Human)	For Injection	Intravenous	25G/500ML	Single-Dose Vial	1942/10/21	Grifols Therapeutics LLC	Rx	Licensed	N/A
Albuked, Plasbumin-20, Plasbumin-25, Plasbumin-5	101138	008	351(a)	Albumin (Human)	For Injection	Intravenous	12.5G/250ML	Single-Dose Vial	1942/10/21	Grifols Therapeutics LLC	Rx	Licensed	N/A
	101062	001	351(a)	Antivenin (Latrodectus mactans)	For Injection	Intravenous	NLT6000U	Single-Dose Vial	1936/02/13	Merck Sharp & Dohme LLC	Rx	Licensed	N/A
	101062	002	351(a)	Antivenin (Latrodectus mactans)	For Injection	Intramuscular	NLT6000U	Single-Dose Vial	1936/02/13	Merck Sharp & Dohme LLC	Rx	Licensed	N/A
	101377	001	351(a)	Insects (Whole Body), Mite Dermatophagoides farinae	Injection	Subcutaneous	10,000AU/ML	Multi-Dose Vial	1930/07/11	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	101377	002	351(a)	Insects (Whole Body), Mite Dermatophagoides farinae	Injection	Percutaneous	10,000AU/ML	Dropper Vial	1930/07/11	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	101378	001	351(a)	Insects (Whole Body), Mite Dermatophagoides pteronyssinus	Injection	Percutaneous	10,000AU/ML	Dropper Vial	1930/07/11	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	101378	002	351(a)	Insects (Whole Body), Mite Dermatophagoides pteronyssinus	Injection	Subcutaneous	10,000AU/ML	Multi-Dose Vial	1930/07/11	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	103324	001	351(a)	Animal Allergens, Standardized Cat Hair	Injection	Percutaneous	10,000BAU/ML	Dropper Vial	1930/07/11	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	103324	002	351(a)	Animal Allergens, Standardized Cat Hair	Injection	Subcutaneous	10,000BAU/ML	Multi-Dose Vial	1930/07/11	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	101379	001	351(a)	Pollens - Grasses, Bermuda Grass Cynodon dactylon	Injection	Percutaneous	10,000BAU/ML	Dropper Vial	1930/06/14	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	101379	002	351(a)	Pollens - Grasses, Bermuda Grass Cynodon dactylon	Injection	Subcutaneous	10,000BAU/ML	Multi-Dose Vial	1930/06/14	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	101380	001	351(a)	Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis	Injection	Percutaneous	10,000BAU/ML	Dropper Vial	1930/06/14	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	101380	002	351(a)	Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis	Injection	Subcutaneous	10,000BAU/ML	Multi-Dose Vial	1930/06/14	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A
	101380	003	351(a)	Pollens - Grasses, Bluegrass, Kentucky (June) Poa pratensis	Injection	Percutaneous	100,000BAU/ML	Dropper Vial	1930/06/14	Allergy Laboratories, Inc.	Disc	Voluntarily Revoked	N/A

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	-