药品注册申请号：210402
申请类型：ANDA (仿制药申请)
申请人：AMNEAL
申请人全名：AMNEAL EU LTD
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 DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG No No AB 2020/09/24 2020/09/24 Prescription
002 DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG No No AB 2020/09/24 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
2024/08/08 SUPPL-12（补充） Approval Labeling STANDARD
2024/08/08 SUPPL-10（补充） Approval Labeling STANDARD
2024/08/08 SUPPL-9（补充） Approval Labeling STANDARD
2024/08/08 SUPPL-8（补充） Approval Labeling STANDARD
2024/08/08 SUPPL-5（补充） Approval Labeling STANDARD
2024/08/08 SUPPL-3（补充） Approval Labeling STANDARD
2020/09/24 ORIG-1（原始申请） Approval 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:DIMETHYL FUMARATE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:120MG 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
204063 001 NDA TECFIDERA DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription Yes No AB 2013/03/27 BIOGEN INC
210531 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/08/17 MYLAN
210440 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/09/24 ALKEM LABS LTD
210460 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/09/24 MSN
210499 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/09/24 ACCORD HLTHCARE
210500 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/09/24 HETERO LABS LTD III
210305 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/09/24 CIPLA
210402 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/09/24 AMNEAL
210226 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/10/05 LUPIN
210309 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/10/06 GLENMARK PHARMS LTD
210382 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2020/10/14 TWI PHARMS
210436 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2021/03/26 SOLA PHARMS
210285 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Discontinued No No AB 2021/12/21 SAWAI USA
210414 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2022/10/18 PRINSTON INC
210385 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2022/12/22 AUROBINDO PHARMA
210377 001 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 120MG Prescription No No AB 2024/06/26 MACLEODS PHARMS LTD
活性成分:DIMETHYL FUMARATE 剂型/给药途径:CAPSULE, DELAYED RELEASE;ORAL 规格:240MG 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
204063 002 NDA TECFIDERA DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription Yes Yes AB 2013/03/27 BIOGEN INC
210531 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/08/17 MYLAN
210440 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/09/24 ALKEM LABS LTD
210460 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/09/24 MSN
210499 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/09/24 ACCORD HLTHCARE
210500 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/09/24 HETERO LABS LTD III
210305 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/09/24 CIPLA
210402 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/09/24 AMNEAL
210226 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/10/05 LUPIN
210309 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/10/06 GLENMARK PHARMS LTD
210382 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2020/10/14 TWI PHARMS
210436 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2021/03/26 SOLA PHARMS
210285 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Discontinued No No AB 2021/12/21 SAWAI USA
210414 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2022/10/18 PRINSTON INC
210385 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2022/12/22 AUROBINDO PHARMA
210377 002 ANDA DIMETHYL FUMARATE DIMETHYL FUMARATE CAPSULE, DELAYED RELEASE;ORAL 240MG Prescription No No AB 2024/06/26 MACLEODS PHARMS LTD
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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