药品注册申请号：021748
申请类型：NDA (新药申请)
申请人：SANTARUS INC
申请人全名：SANTARUS 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 GLUMETZA METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Yes No AB3 2005/06/03 2005/06/03 Prescription
002 GLUMETZA METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Yes Yes AB3 2005/06/03 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
2018/11/07 SUPPL-25（补充） Approval Labeling STANDARD
2017/04/05 SUPPL-20（补充） Approval Labeling 901 REQUIRED
2015/10/27 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
2011/04/13 SUPPL-10（补充） Approval Labeling STANDARD
2010/02/25 SUPPL-8（补充） Approval Labeling STANDARD
2009/06/16 SUPPL-5（补充） Approval Labeling STANDARD
2007/12/28 SUPPL-4（补充） Approval Manufacturing (CMC) N/A
2006/11/01 SUPPL-2（补充） Approval Labeling STANDARD
2005/06/03 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer 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
002 7780987 2025/03/23 Y Y PDF格式
001 6340475 2016/09/19 Y Y U-669 PDF格式**本条是由Drugfuture回溯的历史信息**
6488962 2020/06/20 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6635280 2016/09/19 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6723340 2021/10/25 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 6340475 2016/09/19 Y Y U-669 PDF格式**本条是由Drugfuture回溯的历史信息**
6488962 2020/06/20 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
6723340 2021/10/25 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
8323692 2023/03/30 Y PDF格式**本条是由Drugfuture回溯的历史信息**
8323692 2025/03/23 Y PDF格式**本条是由Drugfuture回溯的历史信息**
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
001 NP 2008/06/03**本条是由Drugfuture回溯的历史信息**
002 NP 2008/06/03**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
活性成分:METFORMIN HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:500MG 治疗等效代码:AB3
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
021748 001 NDA GLUMETZA METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription Yes No AB3 2005/06/03 SANTARUS INC
091664 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2013/07/19 LUPIN LTD
202917 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2016/08/01 SUN PHARM
203755 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2016/08/01 ACTAVIS LABS FL INC
212969 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2019/11/25 GLENMARK PHARMS LTD
213344 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2021/01/12 GRANULES
213962 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2021/03/09 AJANTA PHARMA LTD
213334 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2021/04/16 SCIEGEN PHARMS INC
213356 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2021/12/13 APOTEX
212681 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2022/06/09 PRINSTON INC
212448 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2023/01/10 MICRO LABS
215629 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 500MG Prescription No No AB3 2023/06/20 RK PHARMA
活性成分:METFORMIN HYDROCHLORIDE 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:1GM 治疗等效代码:AB3
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
021748 002 NDA GLUMETZA METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription Yes Yes AB3 2005/06/03 SANTARUS INC
091664 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2013/07/19 LUPIN LTD
202917 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2016/08/01 SUN PHARM
203755 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2016/08/01 ACTAVIS LABS FL INC
212969 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2019/11/25 GLENMARK PHARMS LTD
213344 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2021/01/12 GRANULES
213962 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2021/03/09 AJANTA PHARMA LTD
213334 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2021/04/16 SCIEGEN PHARMS INC
213356 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2021/12/13 APOTEX
212681 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2022/06/09 PRINSTON INC
212448 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2023/01/10 MICRO LABS
215629 002 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2023/06/20 RK PHARMA
211163 001 ANDA METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 1GM Prescription No No AB3 2024/03/13 MACLEODS PHARMS LTD
更多信息
药品NDC数据与药品包装、标签说明书
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