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 209077 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) No No 2018/07/20 2018/07/20 SAGENT PHARMS INC Prescription
GEMCITABINE HYDROCHLORIDE 209077 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) No No 2018/07/20 2018/07/20 SAGENT PHARMS INC Prescription
GEMCITABINE HYDROCHLORIDE 209077 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) No No 2018/07/20 2018/07/20 SAGENT PHARMS INC Prescription
GEMCITABINE HYDROCHLORIDE 210383 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) No No 2019/02/14 2019/02/14 NOVAST LABS Prescription
GEMCITABINE HYDROCHLORIDE 210383 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) No No 2019/02/14 2019/02/14 NOVAST LABS Prescription
GEMCITABINE HYDROCHLORIDE 210383 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) No No 2019/02/14 2019/02/14 NOVAST LABS Prescription
GEMCITABINE HYDROCHLORIDE 207575 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2019/02/22 2019/02/22 SHILPA Prescription
GEMCITABINE HYDROCHLORIDE 207575 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2019/02/22 2019/02/22 SHILPA Prescription
GEMCITABINE HYDROCHLORIDE 210991 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) No No 2019/10/04 2019/10/04 SHILPA Prescription
GEMCITABINE HYDROCHLORIDE 210991 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) No No 2019/10/04 2019/10/04 SHILPA Prescription
GEMCITABINE HYDROCHLORIDE 210991 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) No No 2019/10/04 2019/10/04 SHILPA Prescription
GEMCITABINE HYDROCHLORIDE 212129 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) No No 2020/12/11 2020/12/11 MEITHEAL Prescription
GEMCITABINE HYDROCHLORIDE 212129 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) No No 2020/12/11 2020/12/11 MEITHEAL Prescription
GEMCITABINE HYDROCHLORIDE 212129 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) No No 2020/12/11 2020/12/11 MEITHEAL Prescription
GEMCITABINE HYDROCHLORIDE 206617 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL No No 2021/06/25 2021/06/25 HIKMA INTL PHARMS Prescription
GEMCITABINE HYDROCHLORIDE 206617 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No 2021/06/25 2021/06/25 HIKMA INTL PHARMS Prescription
GEMCITABINE HYDROCHLORIDE 213175 001 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) No No 2023/03/07 2023/03/07 HIKMA Prescription
GEMCITABINE HYDROCHLORIDE 213175 002 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) No No 2023/03/07 2023/03/07 HIKMA Prescription
GEMCITABINE HYDROCHLORIDE 213175 003 ANDA GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) No No 2023/03/07 2023/03/07 HIKMA Prescription
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