美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=GEMCITABINE"
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 090644 001 ANDA GEMCITABINE INJECTABLE; INJECTION 2G No No 2009/12/08 (TA) -- TEVA PARENTERAL None (Tentative Approval)
GEMCITABINE 078460 001 ANDA GEMCITABINE INJECTABLE; INJECTION 200MG No No 2010/01/19 (TA) -- EUROHLTH INTL None (Tentative Approval)
GEMCITABINE HYDROCHLORIDE 079183 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No Yes 2010/11/15 2010/11/15 HOSPIRA INC Prescription
GEMCITABINE HYDROCHLORIDE 077983 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/01/25 2011/01/25 TEVA PHARMS Discontinued
GEMCITABINE HYDROCHLORIDE 077983 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/01/25 2011/01/25 TEVA PHARMS Discontinued
GEMCITABINE HYDROCHLORIDE 090799 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/05/16 2011/07/25 FRESENIUS KABI USA Prescription
GEMCITABINE HYDROCHLORIDE 090799 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/05/16 2011/07/25 FRESENIUS KABI USA Prescription
GEMCITABINE HYDROCHLORIDE 090799 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 2011/05/16 2011/05/16 FRESENIUS KABI USA Prescription
GEMCITABINE HYDROCHLORIDE 090242 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE; INJECTION EQ 200MG BASE/VIAL No No 2011/05/17 -- FRESENIUS KABI USA None (Tentative Approval)
GEMCITABINE HYDROCHLORIDE 090242 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE; INJECTION EQ 1GM BASE/VIAL No No 2011/05/17 -- FRESENIUS KABI USA None (Tentative Approval)
GEMCITABINE HYDROCHLORIDE 090242 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 2011/05/17 2011/05/16 FRESENIUS KABI USA Prescription
GEMCITABINE HYDROCHLORIDE 078339 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/07/25 2011/07/25 HOSPIRA Prescription
GEMCITABINE HYDROCHLORIDE 078339 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/07/25 2011/07/25 HOSPIRA Prescription
GEMCITABINE HYDROCHLORIDE 078433 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/07/25 2011/07/25 SUN PHARM Prescription
GEMCITABINE HYDROCHLORIDE 078433 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/07/25 2011/07/25 SUN PHARM Prescription
GEMCITABINE HYDROCHLORIDE 078759 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/07/25 2011/07/25 TEYRO LABS Prescription
GEMCITABINE HYDROCHLORIDE 078759 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/07/25 2011/07/25 TEYRO LABS Prescription
GEMCITABINE HYDROCHLORIDE 079160 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2011/07/25 2011/07/25 ACTAVIS TOTOWA Discontinued
GEMCITABINE HYDROCHLORIDE 079160 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2011/07/25 2011/07/25 ACTAVIS TOTOWA Discontinued
GEMCITABINE HYDROCHLORIDE 079160 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 2011/07/25 2016/07/28 ACTAVIS TOTOWA Discontinued
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