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
Bayhep B, Hyperhep B S/D	101146	001	351(a)	Hepatitis B Immune Globulin (Human)	Injection	Intramuscular	220U/ML	Pre-Filled Syringe	1977/09/23	Grifols Therapeutics LLC	Rx	Licensed		N/A
Bayhep B, Hyperhep B S/D	101146	002	351(a)	Hepatitis B Immune Globulin (Human)	Injection	Intramuscular	220U/ML	Single-Dose Vial	1977/09/23	Grifols Therapeutics LLC	Rx	Licensed		N/A
Bayhep B, Hyperhep B S/D	101146	003	351(a)	Hepatitis B Immune Globulin (Human)	Injection	Intramuscular	220U/.5ML	Pre-Filled Syringe	1977/09/23	Grifols Therapeutics LLC	Rx	Licensed		N/A
Bayhep B, Hyperhep B S/D	101146	004	351(a)	Hepatitis B Immune Globulin (Human)	Injection	Intramuscular	220U/.5ML	Single-Dose Vial	1977/09/23	Grifols Therapeutics LLC	Rx	Licensed		N/A
Bayhep B, Hyperhep B S/D	101146	005	351(a)	Hepatitis B Immune Globulin (Human)	Injection	Intramuscular	220IU/5ML	Single-Dose Vial	1977/09/23	Grifols Therapeutics LLC	Rx	Licensed		N/A
Pulmolite	017776	001	351(a)	kit for the preparation of technetium Tc-99m albumin aggregated	For Injectable Suspension	Intravenous	1MG/10MG/0.24MG/ 0.7MG/0.13MG/10MG	Vial	1976/11/16	Jubilant DraxImage Inc.	Disc	Licensed	N/A	N/A
Pregnyl	017692	001	351(a)	chorionic gonadotropin	For Injection	Intramuscular	10,000UNITS	Multi-Dose Vial	1976/10/20	Organon USA LLC, a subsidiary of Organon & Co.	Rx	Licensed	N/A	N/A
Alburx	102366	001	351(a)	Albumin (Human)	Injection	Intravenous	25G/100mL	Single-Dose Vial	1976/07/23	CSL Behring AG	Rx	Licensed		N/A
Alburx	102366	002	351(a)	Albumin (Human)	Injection	Intravenous	25G/500ML	Single-Dose Vial	1976/07/23	CSL Behring AG	Rx	Licensed		N/A
Alburx	102366	003	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/50ML	Single-Dose Vial	1976/07/23	CSL Behring AG	Rx	Licensed		N/A
Alburx	102366	004	351(a)	Albumin (Human)	Injection	Intravenous	12.5G/250ML	Single-Dose Vial	1976/07/23	CSL Behring AG	Rx	Licensed		N/A
Macrotec	017833	001	351(a)	kit for the preparation of technetium Tc-99m albumin aggregated	For Injectable Suspension	Intravenous	1.5MG/10MG/0.07MG/0.19MG/1.8MG	Vial	1976/02/23	Bracco Diagnostics Inc.	Disc	Licensed	N/A	N/A
Chromalbin	017835	001	351(a)	albumin chromated CR-51 serum	Injection	Intravenous	100uCi	Single-Dose Vial	1976/02/23	Iso-Tex Diagnostics, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Chromalbin	017835	002	351(a)	albumin chromated CR-51 serum	Injection	Intravenous	250uCi	Single-Dose Vial	1976/02/23	Iso-Tex Diagnostics, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Chromalbin	017835	003	351(a)	albumin chromated CR-51 serum	Injection	Intravenous	500uCi	Single-Dose Vial	1976/02/23	Iso-Tex Diagnostics, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Jeanatope	017836	001	351(a)	iodinated I-125 albumin	Injection	Intravenous	500uCi/0.5ML (1,000uCi/ML)	Multi-Dose Vial	1976/02/23	Iso-Tex Diagnostics, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Jeanatope	017836	002	351(a)	iodinated I-125 albumin	Injection	Intravenous	1,000uCi/ML (1,000uCi/ML)	Multi-Dose Vial	1976/02/23	Iso-Tex Diagnostics, Inc.	Disc	Voluntarily Revoked	N/A	N/A
Megatope	017837	001	351(a)	iodinated I-131 albumin	Injection	Intravenous	0.5mCi	Multi-Dose Vial	1976/02/23	Iso-Tex Diagnostics, Inc.	Disc	Licensed	N/A	N/A
Megatope	017837	002	351(a)	iodinated I-131 albumin	Injection	Intravenous	1mCi	Multi-Dose Vial	1976/02/23	Iso-Tex Diagnostics, Inc.	Rx	Licensed	N/A	N/A
Megatope	017837	003	351(a)	iodinated I-131 albumin	Injection	Intravenous	2mCi	Multi-Dose Vial	1976/02/23	Iso-Tex Diagnostics, Inc.	Disc	Licensed	N/A	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	-