药品注册申请号：040616
申请类型：ANDA (仿制药申请)
申请人：PLIVA
申请人全名：PLIVA 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 WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2MG No No AB 2006/07/05 2006/07/05 Prescription
002 WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2.5MG No No AB 2006/07/05 Prescription
003 WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 3MG No No AB 2006/07/05 Prescription
004 WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 4MG No No AB 2006/07/05 Prescription
005 WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 5MG No No AB 2006/07/05 Prescription
006 WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 6MG No No AB 2006/07/05 Prescription
007 WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 7.5MG No No AB 2006/07/05 Prescription
008 WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 10MG No Yes AB 2006/07/05 Prescription
009 WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 1MG No No AB 2006/07/05 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2006/07/05 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2025/07/02 SUPPL-21（补充） Approval Labeling-Container/Carton Labels,Labeling-Medication Guide,Labeling-Package Insert STANDARD
2018/09/05 SUPPL-16（补充） Approval Labeling-Package Insert UNKNOWN
2018/09/05 SUPPL-15（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2018/09/05 SUPPL-14（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2018/09/05 SUPPL-12（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2018/09/05 SUPPL-9（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2007/07/11 SUPPL-2（补充） Approval Labeling
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:WARFARIN SODIUM; 剂型/给药途径:TABLET;ORAL; 规格:2MG; 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
040145 002 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2MG Discontinued No No AB 1997/03/26 BARR
040301 003 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2MG Prescription No No AB 1999/07/15 TARO
040416 002 ANDA JANTOVEN WARFARIN SODIUM TABLET;ORAL 2MG Prescription No No AB 2003/10/02 UPSHER SMITH LABS
040663 002 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2MG Prescription No No AB 2006/05/30 ZYDUS PHARMS USA
040616 001 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2MG Prescription No No AB 2006/07/05 PLIVA
090935 002 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2MG Prescription No No AB 2011/05/25 INVAGEN PHARMS
202202 002 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2MG Prescription No No AB 2013/03/04 AMNEAL PHARMS
200104 002 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2MG Discontinued No No AB 2013/06/27 AIPING PHARM INC
>>>活性成分:WARFARIN SODIUM; 剂型/给药途径:TABLET;ORAL; 规格:2.5MG; 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
040145 003 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2.5MG Discontinued No No AB 1997/03/26 BARR
040301 004 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2.5MG Prescription No No AB 1999/07/15 TARO
040416 003 ANDA JANTOVEN WARFARIN SODIUM TABLET;ORAL 2.5MG Prescription No No AB 2003/10/02 UPSHER SMITH LABS
040663 003 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2.5MG Prescription No No AB 2006/05/30 ZYDUS PHARMS USA
040616 002 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2.5MG Prescription No No AB 2006/07/05 PLIVA
090935 003 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2.5MG Prescription No No AB 2011/05/25 INVAGEN PHARMS
202202 003 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2.5MG Prescription No No AB 2013/03/04 AMNEAL PHARMS
200104 003 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 2.5MG Discontinued No No AB 2013/06/27 AIPING PHARM INC
>>>活性成分:WARFARIN SODIUM; 剂型/给药途径:TABLET;ORAL; 规格:3MG; 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
040145 008 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 3MG Discontinued No No AB 1998/11/05 BARR
040301 005 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 3MG Prescription No No AB 1999/07/15 TARO
040416 004 ANDA JANTOVEN WARFARIN SODIUM TABLET;ORAL 3MG Prescription No No AB 2003/10/02 UPSHER SMITH LABS
040663 004 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 3MG Prescription No No AB 2006/05/30 ZYDUS PHARMS USA
040616 003 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 3MG Prescription No No AB 2006/07/05 PLIVA
090935 004 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 3MG Prescription No No AB 2011/05/25 INVAGEN PHARMS
202202 004 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 3MG Prescription No No AB 2013/03/04 AMNEAL PHARMS
200104 004 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 3MG Discontinued No No AB 2013/06/27 AIPING PHARM INC
>>>活性成分:WARFARIN SODIUM; 剂型/给药途径:TABLET;ORAL; 规格:4MG; 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
040145 004 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 4MG Discontinued No No AB 1997/03/26 BARR
040301 006 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 4MG Prescription No No AB 1999/07/15 TARO
040416 005 ANDA JANTOVEN WARFARIN SODIUM TABLET;ORAL 4MG Prescription No No AB 2003/10/02 UPSHER SMITH LABS
040663 005 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 4MG Prescription No No AB 2006/05/30 ZYDUS PHARMS USA
040616 004 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 4MG Prescription No No AB 2006/07/05 PLIVA
090935 005 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 4MG Prescription No No AB 2011/05/25 INVAGEN PHARMS
202202 005 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 4MG Prescription No No AB 2013/03/04 AMNEAL PHARMS
200104 005 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 4MG Discontinued No No AB 2013/06/27 AIPING PHARM INC
>>>活性成分:WARFARIN SODIUM; 剂型/给药途径:TABLET;ORAL; 规格:5MG; 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
040145 005 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 5MG Discontinued No No AB 1997/03/26 BARR
040301 007 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 5MG Prescription No No AB 1999/07/15 TARO
040416 006 ANDA JANTOVEN WARFARIN SODIUM TABLET;ORAL 5MG Prescription No No AB 2003/10/02 UPSHER SMITH LABS
040663 006 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 5MG Prescription No No AB 2006/05/30 ZYDUS PHARMS USA
040616 005 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 5MG Prescription No No AB 2006/07/05 PLIVA
090935 006 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 5MG Prescription No No AB 2011/05/25 INVAGEN PHARMS
202202 006 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 5MG Prescription No No AB 2013/03/04 AMNEAL PHARMS
200104 006 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 5MG Discontinued No No AB 2013/06/27 AIPING PHARM INC
>>>活性成分:WARFARIN SODIUM; 剂型/给药途径:TABLET;ORAL; 规格:6MG; 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
040145 009 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 6MG Discontinued No No AB 1998/11/05 BARR
040301 008 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 6MG Prescription No No AB 1999/07/15 TARO
040416 007 ANDA JANTOVEN WARFARIN SODIUM TABLET;ORAL 6MG Prescription No No AB 2003/10/02 UPSHER SMITH LABS
040663 007 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 6MG Prescription No No AB 2006/05/30 ZYDUS PHARMS USA
040616 006 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 6MG Prescription No No AB 2006/07/05 PLIVA
090935 007 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 6MG Prescription No No AB 2011/05/25 INVAGEN PHARMS
202202 007 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 6MG Prescription No No AB 2013/03/04 AMNEAL PHARMS
200104 007 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 6MG Discontinued No No AB 2013/06/27 AIPING PHARM INC
>>>活性成分:WARFARIN SODIUM; 剂型/给药途径:TABLET;ORAL; 规格:7.5MG; 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
040145 006 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 7.5MG Discontinued No No AB 1997/03/26 BARR
040301 009 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 7.5MG Prescription No No AB 1999/07/15 TARO
040416 008 ANDA JANTOVEN WARFARIN SODIUM TABLET;ORAL 7.5MG Prescription No No AB 2003/10/02 UPSHER SMITH LABS
040663 008 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 7.5MG Prescription No No AB 2006/05/30 ZYDUS PHARMS USA
040616 007 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 7.5MG Prescription No No AB 2006/07/05 PLIVA
090935 008 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 7.5MG Prescription No No AB 2011/05/25 INVAGEN PHARMS
202202 008 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 7.5MG Prescription No No AB 2013/03/04 AMNEAL PHARMS
200104 008 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 7.5MG Discontinued No No AB 2013/06/27 AIPING PHARM INC
>>>活性成分:WARFARIN SODIUM; 剂型/给药途径:TABLET;ORAL; 规格:10MG; 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
040145 007 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 10MG Discontinued No No AB 1997/03/26 BARR
040301 001 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 10MG Prescription No No AB 1999/07/15 TARO
040416 009 ANDA JANTOVEN WARFARIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2003/10/02 UPSHER SMITH LABS
040663 009 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2006/05/30 ZYDUS PHARMS USA
040616 008 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 10MG Prescription No Yes AB 2006/07/05 PLIVA
090935 009 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2011/05/25 INVAGEN PHARMS
202202 009 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 10MG Prescription No No AB 2013/03/04 AMNEAL PHARMS
200104 009 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 10MG Discontinued No No AB 2013/06/27 AIPING PHARM INC
>>>活性成分:WARFARIN SODIUM; 剂型/给药途径:TABLET;ORAL; 规格:1MG; 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
040145 001 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 1MG Discontinued No No AB 1997/03/26 BARR
040301 002 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 1MG Prescription No No AB 1999/07/15 TARO
040416 001 ANDA JANTOVEN WARFARIN SODIUM TABLET;ORAL 1MG Prescription No No AB 2003/10/02 UPSHER SMITH LABS
040663 001 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 1MG Prescription No No AB 2006/05/30 ZYDUS PHARMS USA
040616 009 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 1MG Prescription No No AB 2006/07/05 PLIVA
090935 001 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 1MG Prescription No No AB 2011/05/25 INVAGEN PHARMS
202202 001 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 1MG Prescription No No AB 2013/03/04 AMNEAL PHARMS
200104 001 ANDA WARFARIN SODIUM WARFARIN SODIUM TABLET;ORAL 1MG Discontinued No No AB 2013/06/27 AIPING PHARM INC
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