药品注册申请号：214065
申请类型：ANDA (仿制药申请)
申请人：ALKEM LABS LTD
申请人全名：ALKEM LABORATORIES 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 CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG No No AB 2021/04/26 2021/04/26 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
2023/05/25 SUPPL-5（补充） Approval Labeling STANDARD
2021/04/26 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:CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE 剂型/给药途径:CAPSULE;ORAL 规格:5MG;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
012750 001 NDA LIBRAX CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 BAUSCH
211421 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2020/07/07 NUVO PHARMS INC
210579 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2020/07/29 MISEMER
213530 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2020/10/20 CHARTWELL RX
214065 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2021/04/26 ALKEM LABS LTD
214698 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2021/05/10 DR REDDYS
215555 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2021/10/25 AMNEAL
211476 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Discontinued No No AB 2021/11/02 TEVA PHARMS USA
215835 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2022/07/19 MICRO LABS
215453 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2022/07/29 COREPHARMA
216419 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2023/09/14 AUROBINDO PHARMA LTD
216969 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2023/09/15 ALEMBIC
217385 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Discontinued No No AB 2023/12/14 TORRENT
212344 001 ANDA CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE CAPSULE;ORAL 5MG;2.5MG Prescription No No AB 2024/07/08 WINDER LABS LLC
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药品NDC数据与药品包装、标签说明书
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