药品注册申请号：217400
申请类型：ANDA (仿制药申请)
申请人：MSN
申请人全名：MSN LABORATORIES PRIVATE 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 FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG No No AB 2024/08/06 2024/08/06 Prescription
002 FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG No No AB 2024/08/06 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
2024/08/06 ORIG-1（原始申请） Approval STANDARD
>>>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
无
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:FAMOTIDINE; 剂型/给药途径:TABLET;ORAL; 规格:20MG; 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
075704 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2001/04/16 RISING
075718 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2001/04/16 DR REDDYS LABS LTD
075786 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2001/04/16 CHARTWELL RX
075805 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2001/04/16 CARLSBAD
075302 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2001/04/16 MANKIND PHARMA
075511 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2001/04/16 IVAX SUB TEVA PHARMS
075611 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Discontinued No No AB 2001/07/23 APOTEX
077352 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Discontinued No No AB 2005/07/27 PERRIGO R AND D
078916 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2009/05/22 ALEMBIC PHARMS LTD
206530 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2015/12/22 AUROBINDO PHARMA LTD
215689 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2021/10/15 ASCENT PHARMS INC
215767 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2021/11/04 ANNORA PHARMA
215630 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2022/01/07 ALKEM LABS LTD
216441 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2022/06/03 ZYDUS PHARMS
217375 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2023/04/24 ALKEM LABS LTD
217669 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2023/12/20 CONTRACT PHARMACAL
218181 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2023/12/22 RISING
217400 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2024/08/06 MSN
218631 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 20MG Prescription No No AB 2025/03/25 BEXIMCO PHARMS USA
>>>活性成分:FAMOTIDINE; 剂型/给药途径:TABLET;ORAL; 规格:40MG; 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
075704 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2001/04/16 RISING
075718 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2001/04/16 DR REDDYS LABS LTD
075786 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2001/04/16 CHARTWELL RX
075805 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2001/04/16 CARLSBAD
075302 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2001/04/16 MANKIND PHARMA
075511 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2001/04/16 IVAX SUB TEVA PHARMS
075611 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Discontinued No No AB 2001/07/23 APOTEX
077352 001 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Discontinued No No AB 2005/07/27 PERRIGO R AND D
078916 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2009/05/22 ALEMBIC PHARMS LTD
206530 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No Yes AB 2015/12/22 AUROBINDO PHARMA LTD
215689 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2021/10/15 ASCENT PHARMS INC
215767 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2021/11/04 ANNORA PHARMA
215630 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2022/01/07 ALKEM LABS LTD
216441 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2022/06/03 ZYDUS PHARMS
217375 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2023/04/24 ALKEM LABS LTD
217669 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2023/12/20 CONTRACT PHARMACAL
218181 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2023/12/22 RISING
217400 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2024/08/06 MSN
218631 002 ANDA FAMOTIDINE FAMOTIDINE TABLET;ORAL 40MG Prescription No No AB 2025/03/25 BEXIMCO PHARMS USA
更多信息
药品NDC数据与药品包装、标签说明书
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