药品注册申请号：075155
申请类型：ANDA (仿制药申请)
申请人：CHARTWELL MOLECULAR
申请人全名：CHARTWELL MOLECULAR HOLDINGS 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 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG No No AB 1998/10/30 1998/10/30 Prescription
002 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG No No AB 2000/01/13 Prescription
003 ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG No No AB 2000/08/04 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
2014/09/24 SUPPL-34（补充） Approval Manufacturing (CMC)
2004/11/09 SUPPL-28（补充） Approval Labeling
2001/01/26 SUPPL-20（补充） Approval Manufacturing (CMC)
2000/08/04 SUPPL-17（补充） Approval Manufacturing (CMC)
2000/08/04 SUPPL-16（补充） Approval Manufacturing (CMC)
2000/08/04 SUPPL-13（补充） Approval Labeling
2000/08/04 SUPPL-12（补充） Approval Manufacturing (CMC)
2000/08/04 SUPPL-11（补充） Approval Manufacturing (CMC)
2000/08/04 SUPPL-10（补充） Approval Manufacturing (CMC)
2000/06/30 SUPPL-18（补充） Approval Manufacturing (CMC)
2000/01/13 SUPPL-5（补充） Approval Manufacturing (CMC)
2000/01/13 SUPPL-4（补充） Approval Manufacturing (CMC)
2000/01/13 SUPPL-3（补充） Approval Labeling
2000/01/13 SUPPL-2（补充） Approval Manufacturing (CMC)
1999/12/14 SUPPL-14（补充） Approval Manufacturing (CMC)
1999/07/27 SUPPL-8（补充） Approval Labeling
1999/07/27 SUPPL-7（补充） Approval Manufacturing (CMC)
1999/07/27 SUPPL-6（补充） Approval Manufacturing (CMC)
1999/05/14 SUPPL-1（补充） Approval Manufacturing (CMC)
1998/10/30 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:ISOSORBIDE MONONITRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:60MG 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
075155 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 1998/10/30 CHARTWELL MOLECULAR
075395 002 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2000/03/16 ZYDUS HLTHCARE
075522 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2000/04/17 DEXCEL LTD
200495 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2011/06/03 TORRENT PHARMS
210918 002 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2018/11/05 RICONPHARMA LLC
216557 002 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2022/11/07 AUROBINDO PHARMA
214115 003 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG Prescription No No AB 2024/02/08 SHANDONG
218255 002 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 60MG Discontinued No No AB 2024/02/15 ZYDUS PHARMS
活性成分:ISOSORBIDE MONONITRATE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:30MG 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
075155 002 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2000/01/13 CHARTWELL MOLECULAR
075395 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2000/03/16 ZYDUS HLTHCARE
200270 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2011/06/03 TORRENT PHARMS
075522 002 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2016/09/20 DEXCEL LTD
210918 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2018/11/05 RICONPHARMA LLC
216557 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2022/11/07 AUROBINDO PHARMA
214115 002 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG Prescription No No AB 2024/02/08 SHANDONG
218255 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 30MG Discontinued No No AB 2024/02/15 ZYDUS PHARMS
活性成分:ISOSORBIDE MONONITRATE 剂型/给药途径:TABLET, EXTENDED 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
075395 003 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2000/03/16 ZYDUS HLTHCARE
075155 003 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2000/08/04 CHARTWELL MOLECULAR
200495 002 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2011/06/03 TORRENT PHARMS
210822 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2018/08/29 DEXCEL LTD
210918 003 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No Yes AB 2018/11/05 RICONPHARMA LLC
214115 001 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2022/04/29 SHANDONG
216557 003 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG Prescription No No AB 2022/11/07 AUROBINDO PHARMA
218255 003 ANDA ISOSORBIDE MONONITRATE ISOSORBIDE MONONITRATE TABLET, EXTENDED RELEASE;ORAL 120MG Discontinued No No AB 2024/02/15 ZYDUS PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
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