药品注册申请号：017105
申请类型：NDA (新药申请)
申请人：AJENAT PHARMS
申请人全名：AJENAT PHARMACEUTICALS LLC
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 TRANXENE CLORAZEPATE DIPOTASSIUM CAPSULE;ORAL 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1972/06/23 Approved Prior to Jan 1, 1982 Discontinued
002 TRANXENE CLORAZEPATE DIPOTASSIUM CAPSULE;ORAL 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
003 TRANXENE CLORAZEPATE DIPOTASSIUM CAPSULE;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
004 TRANXENE SD CLORAZEPATE DIPOTASSIUM TABLET;ORAL 22.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
005 TRANXENE SD CLORAZEPATE DIPOTASSIUM TABLET;ORAL 11.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
006 TRANXENE CLORAZEPATE DIPOTASSIUM TABLET;ORAL 3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued
007 TRANXENE CLORAZEPATE DIPOTASSIUM TABLET;ORAL 7.5MG Yes No AB Approved Prior to Jan 1, 1982 Prescription
008 TRANXENE CLORAZEPATE DIPOTASSIUM TABLET;ORAL 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None Approved Prior to Jan 1, 1982 Discontinued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
>>>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
1972/06/23 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity 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
2023/01/13 SUPPL-85（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2021/02/05 SUPPL-84（补充） Approval Labeling-Package Insert 901 REQUIRED
2016/12/16 SUPPL-79（补充） Approval Labeling-Package Insert,Labeling-Medication Guide 901 REQUIRED
2015/02/03 SUPPL-78（补充） Approval Manufacturing (CMC) STANDARD
2011/07/19 SUPPL-77（补充） Approval REMS-Modified N/A
2010/06/07 SUPPL-76（补充） Approval Labeling,REMS-Proposal STANDARD
2009/04/23 SUPPL-75（补充） Approval Labeling 901 REQUIRED
2003/03/13 SUPPL-70（补充） Approval Labeling STANDARD
2002/08/28 SUPPL-69（补充） Approval Manufacturing (CMC)-Control STANDARD
2002/02/07 SUPPL-62（补充） Approval Labeling
2002/02/07 SUPPL-59（补充） Approval Labeling
1999/08/04 SUPPL-67（补充） Approval Manufacturing (CMC)-Control STANDARD
1998/05/08 SUPPL-68（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1996/11/05 SUPPL-66（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/11/08 SUPPL-64（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/11/05 SUPPL-60（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1987/08/13 SUPPL-58（补充） Approval Manufacturing (CMC)-Control STANDARD
1987/01/08 SUPPL-57（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/11/14 SUPPL-56（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/08/29 SUPPL-55（补充） Approval Manufacturing (CMC)-Control STANDARD
1986/06/16 SUPPL-53（补充） Approval Manufacturing (CMC)-Control STANDARD
1985/08/26 SUPPL-54（补充） Approval Manufacturing (CMC)-Control STANDARD
1984/02/27 SUPPL-52（补充） Approval Manufacturing (CMC)-Control STANDARD
1981/01/29 SUPPL-39（补充） Approval Efficacy
1980/10/28 SUPPL-45（补充） Approval Manufacturing (CMC)-Control STANDARD
1980/09/08 SUPPL-44（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1980/07/14 SUPPL-43（补充） Approval Labeling
1980/03/10 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1979/12/12 SUPPL-40（补充） Approval Labeling
1979/07/09 SUPPL-29（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/06/07 SUPPL-36（补充） Approval Manufacturing (CMC) STANDARD
1979/06/07 SUPPL-35（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/06/07 SUPPL-34（补充） Approval Manufacturing (CMC)-Control STANDARD
1979/06/05 SUPPL-37（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1979/05/31 SUPPL-38（补充） Approval Manufacturing (CMC)-Control STANDARD
1978/12/06 SUPPL-33（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1978/05/05 SUPPL-31（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1978/04/17 SUPPL-32（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1977/10/21 SUPPL-30（补充） Approval Labeling
1977/10/20 SUPPL-28（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1977/03/18 SUPPL-19（补充） Approval Manufacturing (CMC)-Control STANDARD
1977/01/04 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1976/12/21 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
1976/12/21 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1976/08/04 SUPPL-16（补充） Approval Labeling
1976/08/04 SUPPL-15（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/07/30 SUPPL-17（补充） Approval Manufacturing (CMC)-Control STANDARD
1976/05/07 SUPPL-21（补充） Approval Manufacturing (CMC)-Formulation STANDARD
1975/11/13 SUPPL-9（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/11/05 SUPPL-13（补充） Approval Labeling
1975/09/10 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1975/03/31 SUPPL-8（补充） Approval Manufacturing (CMC)-Control 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:CLORAZEPATE DIPOTASSIUM; 剂型/给药途径:TABLET;ORAL; 规格:7.5MG; 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
017105 007 NDA TRANXENE CLORAZEPATE DIPOTASSIUM TABLET;ORAL 7.5MG Prescription Yes No AB Approved Prior to Jan 1, 1982 AJENAT PHARMS
071858 003 ANDA CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM TABLET;ORAL 7.5MG Prescription No No AB 1987/07/17 AUROBINDO PHARMA
075731 002 ANDA CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM TABLET;ORAL 7.5MG Prescription No No AB 2000/04/27 TARO
215566 002 ANDA CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM TABLET;ORAL 7.5MG Prescription No No AB 2022/06/14 COREPHARMA
213730 002 ANDA CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM TABLET;ORAL 7.5MG Prescription No No AB 2022/06/16 NOVITIUM PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
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