美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=GEMCITABINE"
符合检索条件的记录共 79 条
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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 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
GEMCITABINE HYDROCHLORIDE 090799 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/07/25 2011/07/25 FRESENIUS KABI USA Prescription
GEMCITABINE HYDROCHLORIDE 090799 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/07/25 2011/07/25 FRESENIUS KABI USA Prescription
GEMCITABINE HYDROCHLORIDE 090799 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 2011/07/25 2011/05/16 FRESENIUS KABI USA Prescription
GEMCITABINE HYDROCHLORIDE 091365 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/07/25 2011/07/25 DR REDDYS LABS LTD Prescription
GEMCITABINE HYDROCHLORIDE 091365 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/07/25 2011/07/25 DR REDDYS LABS LTD Prescription
GEMCITABINE HYDROCHLORIDE 091594 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/07/25 2011/07/25 ACCORD HLTHCARE Discontinued
GEMCITABINE HYDROCHLORIDE 091594 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/07/25 2011/07/25 ACCORD HLTHCARE Discontinued
GEMCITABINE HYDROCHLORIDE 091594 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 2011/07/25 2011/07/25 ACCORD HLTHCARE Discontinued
GEMCITABINE HYDROCHLORIDE 200145 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/07/25 2011/07/25 MYLAN LABS LTD Discontinued
GEMCITABINE HYDROCHLORIDE 200145 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/07/25 2011/07/25 MYLAN LABS LTD Discontinued
GEMCITABINE HYDROCHLORIDE 200145 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 2011/07/25 2011/07/25 MYLAN LABS LTD Discontinued
GEMCITABINE HYDROCHLORIDE 200795 001 NDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) Yes Yes 2011/08/04 2011/08/04 HOSPIRA INC Prescription
GEMCITABINE HYDROCHLORIDE 200795 002 NDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) Yes Yes 2011/08/04 2011/08/04 HOSPIRA INC Prescription
GEMCITABINE HYDROCHLORIDE 200795 003 NDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) Yes Yes 2011/08/04 2011/08/04 HOSPIRA INC Prescription
GEMCITABINE HYDROCHLORIDE 090663 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2012/09/10 2012/09/10 HAMELN RDS GMBH Discontinued
GEMCITABINE HYDROCHLORIDE 090663 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2012/09/10 2012/09/10 HAMELN RDS GMBH Discontinued
GEMCITABINE HYDROCHLORIDE 202063 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2012/09/11 2012/09/11 EMCURE PHARMS LTD Discontinued
GEMCITABINE HYDROCHLORIDE 202063 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2012/09/11 2012/09/11 EMCURE PHARMS LTD Discontinued
GEMCITABINE HYDROCHLORIDE 091597 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2013/05/07 2013/05/07 SAGENT PHARMS Discontinued
GEMCITABINE HYDROCHLORIDE 091597 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2013/05/07 2013/05/07 SAGENT PHARMS Discontinued
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