药品注册申请号：078216
申请类型：ANDA (仿制药申请)
申请人：TORRENT PHARMS
申请人全名：TORRENT PHARMACEUTICALS 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 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE No No AB 2007/03/27 2007/03/27 Prescription
002 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE No No AB 2007/03/27 Prescription
003 CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE No No AB 2007/03/27 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
2007/03/27 ORIG-1（原始申请） Approval
>>>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
2024/09/18 SUPPL-40（补充） Approval Labeling-Package Insert,Labeling-Container/Carton Labels,Labeling-Medication Guide STANDARD
2024/09/18 SUPPL-39（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2024/03/28 SUPPL-37（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2022/10/05 SUPPL-34（补充） Approval Labeling-Package Insert STANDARD
2022/10/05 SUPPL-33（补充） Approval Labeling-Package Insert STANDARD
2022/10/05 SUPPL-32（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2022/10/05 SUPPL-29（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2014/12/10 SUPPL-22（补充） Approval Labeling-Package Insert STANDARD
2013/03/28 SUPPL-20（补充） Approval Labeling-Package Insert STANDARD
2012/06/26 SUPPL-18（补充） Approval Labeling-Package Insert STANDARD
2012/06/26 SUPPL-16（补充） Approval Labeling-Package Insert
2011/01/20 SUPPL-9（补充） Approval Labeling
2009/06/22 SUPPL-10（补充） Approval Labeling
2009/01/23 SUPPL-7（补充） Approval Labeling
2008/08/13 SUPPL-3（补充） Approval Labeling
2007/10/25 SUPPL-1（补充） Approval Labeling
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:CITALOPRAM HYDROBROMIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 10MG BASE; 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
020822 001 NDA CELEXA CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Prescription Yes No AB 2000/04/27 ABBVIE
077031 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2004/10/28 AUROBINDO
077038 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2004/10/28 DR REDDYS LABS LTD
077042 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2004/11/05 MYLAN
077044 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2004/11/05 CHARTWELL MOLECULAR
077048 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2004/11/16 COSETTE
077046 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2004/11/24 APOTEX
077045 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2005/04/29 EPIC PHARMA
077534 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2006/10/03 INVAGEN PHARMS
077289 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2006/11/30 AMNEAL PHARMS NY
078216 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Prescription No No AB 2007/03/27 TORRENT PHARMS
077654 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Discontinued No No AB 2009/02/27 GLENMARK PHARMS LTD
>>>活性成分:CITALOPRAM HYDROBROMIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 20MG BASE; 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
020822 002 NDA CELEXA CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Prescription Yes No AB 1998/07/17 ABBVIE
077031 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2004/10/28 AUROBINDO
077038 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2004/10/28 DR REDDYS LABS LTD
077042 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2004/11/05 MYLAN
077044 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2004/11/05 CHARTWELL MOLECULAR
077048 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2004/11/16 COSETTE
077046 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2004/11/24 APOTEX
077045 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2005/04/29 EPIC PHARMA
077534 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2006/10/03 INVAGEN PHARMS
077289 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2006/11/30 AMNEAL PHARMS NY
078216 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Prescription No No AB 2007/03/27 TORRENT PHARMS
077654 002 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Discontinued No No AB 2009/02/27 GLENMARK PHARMS LTD
>>>活性成分:CITALOPRAM HYDROBROMIDE; 剂型/给药途径:TABLET;ORAL; 规格:EQ 40MG BASE; 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
020822 003 NDA CELEXA CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Prescription Yes Yes AB 1998/07/17 ABBVIE
077031 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2004/10/28 AUROBINDO
077038 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2004/10/28 DR REDDYS LABS LTD
077042 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2004/11/05 MYLAN
077044 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2004/11/05 CHARTWELL MOLECULAR
077048 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2004/11/16 COSETTE
077046 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2004/11/24 APOTEX
077045 001 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2005/04/29 EPIC PHARMA
077534 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2006/10/03 INVAGEN PHARMS
077289 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2006/11/30 AMNEAL PHARMS NY
078216 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Prescription No No AB 2007/03/27 TORRENT PHARMS
077654 003 ANDA CITALOPRAM HYDROBROMIDE CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Discontinued No No AB 2009/02/27 GLENMARK 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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