药品注册申请号:005378
申请类型:NDA (新药申请)
申请人:RECORDATI RARE
申请人全名:RECORDATI RARE DISEASES 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
002 DESOXYN METHAMPHETAMINE HYDROCHLORIDE TABLET;ORAL 5MG Yes Yes AA 1943/12/31 Approved Prior to Jan 1, 1982 Prescription
003 DESOXYN METHAMPHETAMINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 10MG No No None Approved Prior to Jan 1, 1982 Discontinued
004 DESOXYN METHAMPHETAMINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 5MG No No None Approved Prior to Jan 1, 1982 Discontinued
005 DESOXYN METHAMPHETAMINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 15MG No No None Approved Prior to Jan 1, 1982 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
2019/04/11 SUPPL 35 Approval Labeling STANDARD
2017/05/19 SUPPL 34 Approval Labeling 901 REQUIRED
2017/01/04 SUPPL 31 Approval Labeling 901 REQUIRED
2015/04/17 SUPPL 30 Approval Labeling 901 REQUIRED
2015/01/26 SUPPL 29 Approval Manufacturing (CMC)
2013/12/03 SUPPL 28 Approval Labeling STANDARD
2013/08/23 SUPPL 27 Approval Labeling STANDARD
2007/05/11 SUPPL 26 Approval Labeling STANDARD
2006/04/12 SUPPL 24 Approval Labeling STANDARD
2001/12/06 SUPPL 20 Approval Labeling STANDARD
2000/11/20 SUPPL 23 Approval Manufacturing (CMC)
1999/06/16 SUPPL 22 Approval Manufacturing (CMC)
1998/05/13 SUPPL 21 Approval Manufacturing (CMC)
1989/07/27 SUPPL 19 Approval Manufacturing (CMC)
1984/02/22 SUPPL 13 Approval Labeling
1983/06/27 SUPPL 15 Approval Labeling
1983/04/25 SUPPL 16 Approval Labeling
1982/09/22 SUPPL 14 Approval Manufacturing (CMC)
1981/09/30 SUPPL 11 Approval Manufacturing (CMC)
1979/03/30 SUPPL 9 Approval Labeling
1975/07/22 SUPPL 6 Approval Labeling
1975/07/22 SUPPL 5 Approval Manufacturing (CMC)
1975/07/22 SUPPL 3 Approval Labeling
1943/12/31 ORIG 1 Approval UNKNOWN
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:METHAMPHETAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AA
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
005378 002 NDA DESOXYN METHAMPHETAMINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription Yes Yes AA Approved Prior to Jan 1, 1982 RECORDATI RARE
091189 001 ANDA METHAMPHETAMINE HYDROCHLORIDE METHAMPHETAMINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AA 2010/04/21 MAYNE PHARMA INC
203846 001 ANDA METHAMPHETAMINE HYDROCHLORIDE METHAMPHETAMINE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AA 2015/11/17 WEST-WARD PHARMS INT
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