药品注册申请号:075102
申请类型:ANDA (仿制药申请)
申请人:SAGENT PHARMS INC
申请人全名:SAGENT PHARMACEUTICALS 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 PROPOFOL PROPOFOL INJECTABLE;INJECTION 10MG/ML No No AB 1999/01/04 1999/01/04 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
2017/12/22 SUPPL-38(补充) Approval Labeling STANDARD
2016/07/05 SUPPL-35(补充) Approval Labeling STANDARD
2015/11/19 SUPPL-32(补充) Approval Labeling STANDARD
2012/12/18 SUPPL-28(补充) Approval Manufacturing (CMC)
2009/02/25 SUPPL-14(补充) Approval Labeling
2005/03/10 SUPPL-13(补充) Approval Labeling
2005/02/08 SUPPL-11(补充) Approval Labeling
2002/09/11 SUPPL-9(补充) Approval Labeling
2002/09/11 SUPPL-8(补充) Approval Manufacturing (CMC)
2002/09/11 SUPPL-7(补充) Approval Manufacturing (CMC)
2002/03/06 SUPPL-6(补充) Approval Manufacturing (CMC)
2000/11/16 SUPPL-5(补充) Approval Labeling
2000/02/10 SUPPL-4(补充) Approval Labeling
1999/07/28 SUPPL-1(补充) Approval Manufacturing (CMC)
1999/05/14 SUPPL-3(补充) Approval Labeling
1999/03/23 SUPPL-2(补充) Approval Labeling
1999/01/04 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
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
与本品治疗等效的药品
活性成分:PROPOFOL 剂型/给药途径:INJECTABLE;INJECTION 规格:10MG/ML 治疗等效代码:AB
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
019627 002 NDA DIPRIVAN PROPOFOL INJECTABLE;INJECTION 10MG/ML Prescription Yes Yes AB 1996/06/11 FRESENIUS KABI USA
075102 001 ANDA PROPOFOL PROPOFOL INJECTABLE;INJECTION 10MG/ML Prescription No No AB 1999/01/04 SAGENT PHARMS INC
074848 001 ANDA PROPOFOL PROPOFOL INJECTABLE;INJECTION 10MG/ML Prescription No No AB 2005/04/19 HIKMA
077908 001 ANDA PROPOFOL PROPOFOL INJECTABLE;INJECTION 10MG/ML Prescription No No AB 2006/03/17 HOSPIRA
205307 001 ANDA PROPOFOL PROPOFOL INJECTABLE;INJECTION 10MG/ML Discontinued No No AB 2015/12/22 WATSON LABS INC
205067 001 ANDA PROPOFOL PROPOFOL INJECTABLE;INJECTION 10MG/ML Prescription No No AB 2018/11/15 DR REDDYS
205576 001 ANDA PROPOFOL PROPOFOL INJECTABLE;INJECTION 10MG/ML Prescription No No AB 2020/09/16 INNOPHARMA
206408 001 ANDA PROPOFOL PROPOFOL INJECTABLE;INJECTION 10MG/ML Prescription No No AB 2021/10/12 AVET LIFESCIENCES
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药品NDC数据与药品包装、标签说明书
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