药品注册申请号：021434
申请类型：NDA (新药申请)
申请人：UPJOHN
申请人全名：UPJOHN US 2 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 XANAX XR ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 0.5MG Yes No AB 2003/01/17 2003/01/17 Prescription
002 XANAX XR ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 1MG Yes No AB 2003/01/17 Prescription
003 XANAX XR ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 2MG Yes No AB 2003/01/17 Prescription
004 XANAX XR ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 3MG Yes Yes AB 2003/01/17 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
2023/01/13 SUPPL-22（补充） Approval Labeling STANDARD
2021/03/01 SUPPL-18（补充） Approval Labeling STANDARD
2021/02/05 SUPPL-21（补充） Approval Labeling 901 REQUIRED
2016/12/16 SUPPL-16（补充） Approval Labeling 901 REQUIRED
2016/04/07 SUPPL-15（补充） Approval Manufacturing (CMC) STANDARD
2013/12/04 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
2011/08/23 SUPPL-7（补充） Approval Labeling UNKNOWN
2011/06/01 SUPPL-6（补充） Approval Labeling UNKNOWN
2004/04/02 SUPPL-1（补充） Approval Labeling STANDARD
2003/01/17 ORIG-1（原始申请） Approval Type 3 - New Dosage Form 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:ALPRAZOLAM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:0.5MG 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
021434 001 NDA XANAX XR ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 0.5MG Prescription Yes No AB 2003/01/17 UPJOHN
078056 001 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 0.5MG Prescription No No AB 2007/02/13 ACTAVIS ELIZABETH
078387 001 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 0.5MG Prescription No No AB 2008/05/30 AMNEAL PHARMS NY
078449 001 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 0.5MG Prescription No No AB 2008/11/12 APOTEX INC
090871 001 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 0.5MG Prescription No No AB 2011/06/07 AUROBINDO PHARMA
078469 001 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 0.5MG Discontinued No No AB 2011/09/29 ANCHEN PHARMS
活性成分:ALPRAZOLAM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:1MG 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
021434 002 NDA XANAX XR ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 1MG Prescription Yes No AB 2003/01/17 UPJOHN
078056 002 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 1MG Prescription No No AB 2007/02/13 ACTAVIS ELIZABETH
078387 002 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 1MG Prescription No No AB 2008/05/30 AMNEAL PHARMS NY
090871 002 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 1MG Prescription No No AB 2011/06/07 AUROBINDO PHARMA
078469 002 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 1MG Discontinued No No AB 2011/09/29 ANCHEN PHARMS
078449 004 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 1MG Prescription No No AB 2015/12/23 APOTEX INC
活性成分:ALPRAZOLAM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:2MG 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
021434 003 NDA XANAX XR ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 2MG Prescription Yes No AB 2003/01/17 UPJOHN
078056 003 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 2MG Prescription No No AB 2007/02/13 ACTAVIS ELIZABETH
078387 003 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 2MG Prescription No No AB 2008/05/30 AMNEAL PHARMS NY
078449 002 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 2MG Prescription No No AB 2008/11/12 APOTEX INC
090871 003 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 2MG Prescription No No AB 2011/06/07 AUROBINDO PHARMA
078469 003 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 2MG Discontinued No No AB 2011/09/29 ANCHEN PHARMS
活性成分:ALPRAZOLAM 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL 规格:3MG 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
021434 004 NDA XANAX XR ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 3MG Prescription Yes Yes AB 2003/01/17 UPJOHN
078056 004 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2007/02/13 ACTAVIS ELIZABETH
078387 004 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2008/05/30 AMNEAL PHARMS NY
078449 003 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2008/11/12 APOTEX INC
090871 004 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 3MG Prescription No No AB 2011/06/07 AUROBINDO PHARMA
078469 004 ANDA ALPRAZOLAM ALPRAZOLAM TABLET, EXTENDED RELEASE;ORAL 3MG Discontinued No No AB 2011/09/29 ANCHEN PHARMS
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
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