药品注册申请号：090799
申请类型：ANDA (仿制药申请)
申请人：FRESENIUS KABI USA
申请人全名：FRESENIUS KABI USA LLC
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 EQ 200MG BASE/VIAL No No AP;AP 2011/05/16 2011/07/25 Prescription
002 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No AP;AP 2011/07/25 Prescription
003 GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No AP;AP 2011/05/16 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
2020/10/06 SUPPL-15（补充） Approval Labeling STANDARD
2020/10/06 SUPPL-14（补充） Approval Labeling STANDARD
2017/09/18 SUPPL-10（补充） Approval Labeling STANDARD
2011/07/25 ORIG-2（原始申请） Approval
2011/05/16 ORIG-1（原始申请） Approval
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:EQ 200MG BASE/VIAL 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
078339 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 HOSPIRA
078433 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 SUN PHARM
078759 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 TEYRO LABS
090799 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 FRESENIUS KABI USA
091365 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 DR REDDYS LABS LTD
091594 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Discontinued No No AP 2011/07/25 ACCORD HLTHCARE
202485 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No Yes AP 2013/05/07 JIANGSU HANSOH PHARM
204520 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2016/01/05 GLAND PHARMA LTD
207575 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2019/02/22 SHILPA
206617 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2021/06/25 HIKMA INTL PHARMS
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 200MG BASE/VIAL 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
078339 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 HOSPIRA
078433 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 SUN PHARM
078759 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 TEYRO LABS
090799 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 FRESENIUS KABI USA
091365 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2011/07/25 DR REDDYS LABS LTD
091594 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Discontinued No No AP 2011/07/25 ACCORD HLTHCARE
202485 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No Yes AP 2013/05/07 JIANGSU HANSOH PHARM
204520 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2016/01/05 GLAND PHARMA LTD
207575 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2019/02/22 SHILPA
206617 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MG BASE/VIAL Prescription No No AP 2021/06/25 HIKMA INTL PHARMS
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM BASE/VIAL 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
078339 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 HOSPIRA
078433 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 SUN PHARM
078759 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 TEYRO LABS
090799 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 FRESENIUS KABI USA
091365 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 DR REDDYS LABS LTD
091594 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Discontinued No No AP 2011/07/25 ACCORD HLTHCARE
202485 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No Yes AP 2013/05/07 JIANGSU HANSOH PHARM
204520 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2016/01/05 GLAND PHARMA LTD
207575 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2019/02/22 SHILPA
206617 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2021/06/25 HIKMA INTL PHARMS
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM BASE/VIAL 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
078339 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 HOSPIRA
078433 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 SUN PHARM
078759 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 TEYRO LABS
090799 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 FRESENIUS KABI USA
091365 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2011/07/25 DR REDDYS LABS LTD
091594 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Discontinued No No AP 2011/07/25 ACCORD HLTHCARE
202485 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No Yes AP 2013/05/07 JIANGSU HANSOH PHARM
204520 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2016/01/05 GLAND PHARMA LTD
207575 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2019/02/22 SHILPA
206617 002 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 1GM BASE/VIAL Prescription No No AP 2021/06/25 HIKMA INTL PHARMS
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2GM BASE/VIAL 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
079183 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No Yes AP 2010/11/15 HOSPIRA INC
090242 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2011/05/16 FRESENIUS KABI USA
090799 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2011/05/16 FRESENIUS KABI USA
091594 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Discontinued No No AP 2011/07/25 ACCORD HLTHCARE
202997 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2013/05/07 DR REDDYS LABS LTD
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 2GM BASE/VIAL 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
079183 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No Yes AP 2010/11/15 HOSPIRA INC
090242 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2011/05/16 FRESENIUS KABI USA
090799 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2011/05/16 FRESENIUS KABI USA
091594 003 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Discontinued No No AP 2011/07/25 ACCORD HLTHCARE
202997 001 ANDA GEMCITABINE HYDROCHLORIDE GEMCITABINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 2GM BASE/VIAL Prescription No No AP 2013/05/07 DR REDDYS LABS LTD
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