药品注册申请号：011522
申请类型：NDA (新药申请)
申请人：TEVA WOMENS
申请人全名：TEVA WOMENS HEALTH 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
007 ADDERALL 10 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1960/01/19 1996/02/13 Discontinued
008 ADDERALL 20 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1996/02/13 Discontinued
009 ADDERALL 5 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/05/12 Discontinued
010 ADDERALL 30 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1997/05/12 Discontinued
011 ADDERALL 7.5 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2000/08/31 Discontinued
012 ADDERALL 12.5 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2000/08/31 Discontinued
013 ADDERALL 15 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE TABLET;ORAL 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2000/08/31 Discontinued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
2023/10/13 SUPPL-45（补充） Approval Labeling STANDARD
2022/02/25 SUPPL-44（补充） Approval Labeling 901 REQUIRED
2017/01/04 SUPPL-43（补充） Approval Labeling 901 REQUIRED
2015/10/01 SUPPL-42（补充） Approval Labeling STANDARD
2015/04/17 SUPPL-41（补充） Approval Labeling 901 REQUIRED
2007/06/07 SUPPL-40（补充） Approval Labeling STANDARD
2006/07/26 SUPPL-37（补充） Approval Labeling STANDARD
2006/07/26 SUPPL-34（补充） Approval Labeling STANDARD
2005/08/02 SUPPL-33（补充） Approval Labeling STANDARD
2005/08/02 SUPPL-32（补充） Approval Labeling STANDARD
2002/11/08 SUPPL-30（补充） Approval Manufacturing (CMC) STANDARD
2002/04/11 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
2001/12/10 SUPPL-28（补充） Approval Manufacturing (CMC) STANDARD
2000/08/31 SUPPL-26（补充） Approval Manufacturing (CMC) STANDARD
2000/07/24 SUPPL-27（补充） Approval Manufacturing (CMC) STANDARD
2000/02/15 SUPPL-25（补充） Approval Manufacturing (CMC) STANDARD
2000/01/26 SUPPL-24（补充） Approval Manufacturing (CMC) STANDARD
1999/11/12 SUPPL-22（补充） Approval Manufacturing (CMC) STANDARD
1999/09/20 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1999/05/21 SUPPL-21（补充） Approval Manufacturing (CMC) STANDARD
1999/02/23 SUPPL-20（补充） Approval Manufacturing (CMC) STANDARD
1998/03/16 SUPPL-19（补充） Approval Manufacturing (CMC) STANDARD
1998/01/08 SUPPL-18（补充） Approval Manufacturing (CMC) STANDARD
1997/11/14 SUPPL-16（补充） Approval Manufacturing (CMC) STANDARD
1997/07/25 SUPPL-17（补充） Approval Labeling STANDARD
1997/07/17 SUPPL-15（补充） Approval Labeling STANDARD
1997/07/17 SUPPL-11（补充） Approval Labeling STANDARD
1997/06/13 SUPPL-14（补充） Approval Manufacturing (CMC) STANDARD
1997/05/12 SUPPL-13（补充） Approval Manufacturing (CMC) STANDARD
1997/01/29 SUPPL-12（补充） Approval Manufacturing (CMC) STANDARD
1996/02/13 SUPPL-10（补充） Approval Manufacturing (CMC) STANDARD
1996/02/13 SUPPL-9（补充） Approval Labeling
1960/01/19 ORIG-1（原始申请） Approval Type 2 New Active Ingredient and Type 4 New Combination 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
007 6384020 2020/07/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6384020*PED 2021/01/06 PDF格式**本条是由Drugfuture回溯的历史信息**
008 6384020 2020/07/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6384020*PED 2021/01/06 PDF格式**本条是由Drugfuture回溯的历史信息**
009 6384020 2020/07/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6384020*PED 2021/01/06 PDF格式**本条是由Drugfuture回溯的历史信息**
010 6384020 2020/07/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6384020*PED 2021/01/06 PDF格式**本条是由Drugfuture回溯的历史信息**
011 6384020 2020/07/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6384020*PED 2021/01/06 PDF格式**本条是由Drugfuture回溯的历史信息**
012 6384020 2020/07/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6384020*PED 2021/01/06 PDF格式**本条是由Drugfuture回溯的历史信息**
013 6384020 2020/07/06 PDF格式**本条是由Drugfuture回溯的历史信息**
6384020*PED 2021/01/06 PDF格式**本条是由Drugfuture回溯的历史信息**
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
本品无治疗等效药品
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
©2006-2024 DrugFuture->U.S. FDA Drugs Database