药品注册申请号:020822
申请类型:NDA (新药申请)
申请人:ABBVIE
申请人全名:ABBVIE 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 CELEXA CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 10MG BASE Yes No AB 1998/07/17 2000/04/27 Prescription
002 CELEXA CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 20MG BASE Yes No AB 1998/07/17 Prescription
003 CELEXA CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 40MG BASE Yes Yes AB 1998/07/17 Prescription
004 CELEXA CITALOPRAM HYDROBROMIDE TABLET;ORAL EQ 60MG BASE No No None 1998/07/17 Discontinued
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
2024/04/19 SUPPL-55(补充) Approval Labeling STANDARD
2023/08/18 SUPPL-54(补充) Approval Labeling STANDARD
2022/02/04 SUPPL-41(补充) Approval Labeling STANDARD
2021/09/20 SUPPL-52(补充) Approval Labeling 901 REQUIRED
2019/01/11 SUPPL-51(补充) Approval Labeling STANDARD
2017/01/04 SUPPL-47(补充) Approval Labeling 901 REQUIRED
2014/07/08 SUPPL-46(补充) Approval Labeling 901 REQUIRED
2014/04/16 SUPPL-45(补充) Approval Labeling STANDARD
2013/06/17 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
2012/12/03 SUPPL-43(补充) Approval Labeling STANDARD
2012/03/27 SUPPL-42(补充) Approval Labeling STANDARD
2011/08/12 SUPPL-40(补充) Approval Labeling UNKNOWN
2011/08/12 SUPPL-38(补充) Approval Labeling STANDARD
2009/01/30 SUPPL-37(补充) Approval Labeling STANDARD
2008/09/18 SUPPL-35(补充) Approval Labeling STANDARD
2007/08/02 SUPPL-34(补充) Approval Labeling STANDARD
2005/02/18 SUPPL-29(补充) Approval Labeling STANDARD
2004/05/20 SUPPL-27(补充) Approval Labeling STANDARD
2004/04/08 SUPPL-23(补充) Approval Labeling STANDARD
2002/11/19 SUPPL-19(补充) Approval Labeling STANDARD
2002/05/30 SUPPL-15(补充) Approval Manufacturing (CMC) STANDARD
2001/07/10 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
2001/06/27 SUPPL-11(补充) Approval Labeling STANDARD
2001/05/17 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
2000/11/22 SUPPL-12(补充) Approval Manufacturing (CMC) STANDARD
2000/07/13 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
2000/06/27 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
2000/04/27 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1999/12/07 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1999/12/07 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1999/10/21 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1999/10/19 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1999/08/13 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1998/07/17 ORIG-1(原始申请) Approval Type 1 - New Molecular Entity 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
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
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 Prescription 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 Prescription 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 Prescription 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 Prescription 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 Prescription 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 Prescription No No AB 2009/02/27 GLENMARK PHARMS LTD
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