药品注册申请号：200795
申请类型：NDA (新药申请)
申请人：HOSPIRA INC
申请人全名：HOSPIRA INC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) Yes Yes AP 2011/08/04 2011/08/04 Prescription
002 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) Yes Yes AP 2011/08/04 Prescription
003 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) Yes Yes AP 2011/08/04 Prescription
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2019/06/21 SUPPL-10（补充） Approval Labeling STANDARD
2018/01/26 SUPPL-8（补充） Approval Labeling STANDARD
2016/04/07 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
2014/05/08 SUPPL-5（补充） Approval Labeling 901 REQUIRED
2013/11/27 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
2013/09/05 SUPPL-4（补充） Approval Labeling STANDARD
2013/06/20 SUPPL-2（补充） Approval Manufacturing (CMC) STANDARD
2012/12/18 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
2011/08/04 ORIG-1（原始申请） Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
无
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:200MG/5.26ML (38MG/ML) 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
200795 001 NDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) Prescription Yes Yes AP 2011/08/04 HOSPIRA INC
205242 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) Prescription No No AP 2017/12/06 MYLAN LABS LTD
209077 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) Prescription No No AP 2018/07/20 SAGENT PHARMS INC
210383 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) Prescription No No AP 2019/02/14 NOVAST LABS
210991 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) Prescription No No AP 2019/10/04 SHILPA
212129 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) Prescription No No AP 2020/12/11 MEITHEAL
213175 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 200MG/5.26ML (38MG/ML) Prescription No No AP 2023/03/07 HIKMA
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1GM/26.3ML (38MG/ML) 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
200795 002 NDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) Prescription Yes Yes AP 2011/08/04 HOSPIRA INC
205242 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) Prescription No No AP 2017/12/06 MYLAN LABS LTD
209077 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) Prescription No No AP 2018/07/20 SAGENT PHARMS INC
210383 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) Prescription No No AP 2019/02/14 NOVAST LABS
210991 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) Prescription No No AP 2019/10/04 SHILPA
212129 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) Prescription No No AP 2020/12/11 MEITHEAL
213175 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 1GM/26.3ML (38MG/ML) Prescription No No AP 2023/03/07 HIKMA
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/52.6ML (38MG/ML) 治疗等效代码:AP
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
200795 003 NDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) Prescription Yes Yes AP 2011/08/04 HOSPIRA INC
205242 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) Prescription No No AP 2017/12/06 MYLAN LABS LTD
209077 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) Prescription No No AP 2018/07/20 SAGENT PHARMS INC
210383 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) Prescription No No AP 2019/02/14 NOVAST LABS
210991 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) Prescription No No AP 2019/10/04 SHILPA
212129 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) Prescription No No AP 2020/12/11 MEITHEAL
213175 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION 2GM/52.6ML (38MG/ML) Prescription No No AP 2023/03/07 HIKMA
更多信息
药品NDC数据与药品包装、标签说明书
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