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 HYDROCHLORIDE 202031 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2013/05/07 2013/05/07 AM REGENT Discontinued
GEMCITABINE HYDROCHLORIDE 202031 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2013/05/07 2013/05/07 AM REGENT Discontinued
GEMCITABINE HYDROCHLORIDE 202485 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No Yes 2013/05/07 2013/05/07 JIANGSU HANSOH PHARM Prescription
GEMCITABINE HYDROCHLORIDE 202485 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No Yes 2013/05/07 2013/05/07 JIANGSU HANSOH PHARM Prescription
GEMCITABINE HYDROCHLORIDE 202997 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No 2013/05/07 2013/05/07 DR REDDYS LABS LTD Prescription
GEMCITABINE HYDROCHLORIDE 204520 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2016/01/05 2016/01/05 GLAND PHARMA LTD Prescription
GEMCITABINE HYDROCHLORIDE 204520 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2016/01/05 2016/01/05 GLAND PHARMA LTD Prescription
GEMCITABINE HYDROCHLORIDE 204549 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) No No 2016/04/11 2016/04/11 ACTAVIS INC Discontinued
GEMCITABINE HYDROCHLORIDE 204549 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) No No 2016/04/11 2016/04/11 ACTAVIS INC Discontinued
GEMCITABINE HYDROCHLORIDE 204549 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) No No 2016/04/11 2016/04/11 ACTAVIS INC Discontinued
GEMCITABINE HYDROCHLORIDE 206776 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) No No 2017/05/23 2017/05/23 APOTEX Discontinued
GEMCITABINE HYDROCHLORIDE 206776 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) No No 2017/05/23 2017/05/23 APOTEX Discontinued
GEMCITABINE HYDROCHLORIDE 206776 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) No No 2017/05/23 2017/05/23 APOTEX Discontinued
GEMCITABINE HYDROCHLORIDE 209604 001 NDA GEMCITABINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 200MG/2ML (100MG/ML) Yes Yes 2017/08/03 2017/08/03 ACCORD HLTHCARE Prescription
GEMCITABINE HYDROCHLORIDE 209604 002 NDA GEMCITABINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 1GM/10ML (100MG/ML) Yes Yes 2017/08/03 2017/08/03 ACCORD HLTHCARE Prescription
GEMCITABINE HYDROCHLORIDE 209604 003 NDA GEMCITABINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 1.5GM/15ML (100MG/ML) Yes Yes 2017/08/03 2017/08/03 ACCORD HLTHCARE Prescription
GEMCITABINE HYDROCHLORIDE 209604 004 NDA GEMCITABINE HYDROCHLORIDE SOLUTION;INTRAVENOUS 2GM/20ML (100MG/ML) Yes Yes 2017/08/03 2017/08/03 ACCORD HLTHCARE Prescription
GEMCITABINE HYDROCHLORIDE 205242 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) No No 2017/12/06 2017/12/06 MYLAN LABS LTD Prescription
GEMCITABINE HYDROCHLORIDE 205242 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) No No 2017/12/06 2017/12/06 MYLAN LABS LTD Prescription
GEMCITABINE HYDROCHLORIDE 205242 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) No No 2017/12/06 2017/12/06 MYLAN LABS LTD Prescription
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