美国FDA药品橙皮书数据库
(U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations)
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 是否参比药物 是否生物等效参考标准 治疗等效代码 产品批准日期 申请人 市场状态 专利及市场独占权
VI-TWEL 007012 002 NDA CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML No No Approved Prior to Jan 1, 1982 BAYER HLTHCARE DISCN 详细信息
VIBISONE 080557 003 ANDA CYANOCOBALAMIN INJECTABLE;INJECTION 1MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 FRESENIUS KABI USA RX 详细信息
VIBRAMYCIN 050442 002 NDA DOXYCYCLINE HYCLATE INJECTABLE;INJECTION EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
VIBRAMYCIN 050442 001 NDA DOXYCYCLINE HYCLATE INJECTABLE;INJECTION EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
VINBLASTINE SULFATE 089011 001 ANDA VINBLASTINE SULFATE INJECTABLE;INJECTION 10MG/VIAL No No 1985/11/18 ABRAXIS PHARM DISCN 详细信息
VINBLASTINE SULFATE 089515 001 ANDA VINBLASTINE SULFATE INJECTABLE;INJECTION 1MG/ML No Yes 1987/04/29 FRESENIUS KABI USA RX 详细信息
VINBLASTINE SULFATE 089395 001 ANDA VINBLASTINE SULFATE INJECTABLE;INJECTION 10MG/VIAL No Yes 1987/04/09 HIKMA RX 详细信息
VINBLASTINE SULFATE 089565 001 ANDA VINBLASTINE SULFATE INJECTABLE;INJECTION 10MG/VIAL No No 1987/08/18 HOSPIRA DISCN 详细信息
VINCASAR PFS 071426 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 1MG/ML No No 1987/07/17 TEVA PARENTERAL DISCN 详细信息
VINCREX 070867 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 5MG/VIAL No No 1988/07/12 BRISTOL MYERS SQUIBB DISCN 详细信息
VINCRISTINE SULFATE 070873 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 1MG/ML No No 1987/02/19 ABIC DISCN 详细信息
VINCRISTINE SULFATE 070411 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 1MG/ML No No 1986/09/10 ABRAXIS PHARM DISCN 详细信息
VINCRISTINE SULFATE 076296 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 1MG/ML No No 2002/12/20 FRESENIUS KABI USA DISCN 详细信息
VINCRISTINE SULFATE 076401 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 1MG/ML No No 2003/10/28 FRESENIUS KABI USA DISCN 详细信息
VINCRISTINE SULFATE 071559 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 1MG/VIAL No No 1988/04/11 HOSPIRA DISCN 详细信息
VINCRISTINE SULFATE 071560 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 2MG/VIAL No No 1988/04/11 HOSPIRA DISCN 详细信息
VINCRISTINE SULFATE 071561 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 5MG/VIAL No No 1988/04/11 HOSPIRA DISCN 详细信息
VINCRISTINE SULFATE PFS 071484 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 1MG/ML No Yes AP 1988/04/19 HOSPIRA RX 详细信息
VINCRISTINE SULFATE PFS 075493 001 ANDA VINCRISTINE SULFATE INJECTABLE;INJECTION 1MG/ML No No AP 1999/09/01 TEVA PHARMS USA RX 详细信息
VINORELBINE TARTRATE 078011 001 ANDA VINORELBINE TARTRATE INJECTABLE;INJECTION EQ 10MG BASE/ML No No AP 2009/07/22 ACTAVIS TOTOWA RX 详细信息
当前数据更新日期:2022年08月14日,更多信息请点击此处查询美国FDA药品数据库
数据库说明:本数据与美国FDA官方药品橙皮书数据库同步,在官方数据基础上,提供更全面的检索方式和更简洁高效、完整的数据展现,并且可以回溯专利及市场独占权(市场排他数据)历史信息。
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