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SULFATE TABLET;ORAL 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1960/01/19 1996/02/13 Discontinued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SULFATE TABLET;ORAL 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1996/02/13 Discontinued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SULFATE TABLET;ORAL 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/05/12 Discontinued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SULFATE TABLET;ORAL 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 1997/05/12 Discontinued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TABLET;ORAL 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 2000/08/31 Discontinued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TABLET;ORAL 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 2000/08/31 Discontinued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SULFATE TABLET;ORAL 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No None 2000/08/31 Discontinued
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2017/01/04 SUPPL 43 Approval Labeling 901 REQUIRED
2015/10/01 SUPPL 42 Approval Labeling STANDARD
2015/04/17 SUPPL 41 Approval Labeling 901 REQUIRED
2007/06/07 SUPPL 40 Approval Labeling STANDARD
2006/07/26 SUPPL 37 Approval Labeling STANDARD
2006/07/26 SUPPL 34 Approval Labeling STANDARD
2005/08/02 SUPPL 33 Approval Labeling STANDARD
2005/08/02 SUPPL 32 Approval Labeling STANDARD
2002/11/08 SUPPL 30 Approval Manufacturing (CMC) STANDARD
2002/04/11 SUPPL 29 Approval Manufacturing (CMC) STANDARD
2001/12/10 SUPPL 28 Approval Manufacturing (CMC) STANDARD
2000/08/31 SUPPL 26 Approval Manufacturing (CMC) STANDARD
2000/07/24 SUPPL 27 Approval Manufacturing (CMC) STANDARD
2000/02/15 SUPPL 25 Approval Manufacturing (CMC) STANDARD
2000/01/26 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1999/11/12 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1999/09/20 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1999/05/21 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1999/02/23 SUPPL 20 Approval Manufacturing (CMC) STANDARD
1998/03/16 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1998/01/08 SUPPL 18 Approval Manufacturing (CMC) STANDARD
1997/11/14 SUPPL 16 Approval Manufacturing (CMC) STANDARD
1997/07/25 SUPPL 17 Approval Labeling STANDARD
1997/07/17 SUPPL 15 Approval Labeling STANDARD
1997/07/17 SUPPL 11 Approval Labeling STANDARD
1997/06/13 SUPPL 14 Approval Manufacturing (CMC) STANDARD
1997/05/12 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1997/01/29 SUPPL 12 Approval Manufacturing (CMC) STANDARD
1996/02/13 SUPPL 10 Approval Manufacturing (CMC) STANDARD
1996/02/13 SUPPL 9 Approval Labeling
1960/01/19 ORIG 1 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
6384020*PED 2021/01/06 PDF格式
008 6384020 2020/07/06 PDF格式
6384020*PED 2021/01/06 PDF格式
009 6384020 2020/07/06 PDF格式
6384020*PED 2021/01/06 PDF格式
010 6384020 2020/07/06 PDF格式
6384020*PED 2021/01/06 PDF格式
011 6384020 2020/07/06 PDF格式
6384020*PED 2021/01/06 PDF格式
012 6384020 2020/07/06 PDF格式
6384020*PED 2021/01/06 PDF格式
013 6384020 2020/07/06 PDF格式
6384020*PED 2021/01/06 PDF格式
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
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
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