药品注册申请号:010841
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
001 PEGANONE ETHOTOIN TABLET;ORAL 250MG Yes Yes None 1957/04/22 Approved Prior to Jan 1, 1982 Prescription
003 PEGANONE ETHOTOIN TABLET;ORAL 500MG 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
2017/02/27 SUPPL 25 Approval Manufacturing (CMC) N/A
2013/01/23 SUPPL 24 Approval Manufacturing (CMC) PRIORITY
2011/05/31 SUPPL 23 Approval REMS N/A
2010/06/07 SUPPL 22 Approval Labeling STANDARD
2009/04/23 SUPPL 21 Approval Labeling 901 REQUIRED
2007/02/02 SUPPL 20 Approval Labeling STANDARD
2003/09/26 SUPPL 14 Approval Labeling STANDARD
2003/09/26 SUPPL 13 Approval Labeling
2002/12/10 SUPPL 17 Approval Manufacturing (CMC) PRIORITY
2002/04/04 SUPPL 16 Approval Manufacturing (CMC) PRIORITY
1998/05/13 SUPPL 15 Approval Manufacturing (CMC) PRIORITY
1984/11/13 SUPPL 12 Approval Manufacturing (CMC) PRIORITY
1983/10/28 SUPPL 11 Approval Manufacturing (CMC) PRIORITY
1982/11/04 SUPPL 10 Approval Manufacturing (CMC) PRIORITY
1982/07/12 SUPPL 9 Approval Manufacturing (CMC) PRIORITY
1980/02/05 SUPPL 5 Approval Manufacturing (CMC) PRIORITY
1957/04/22 ORIG 1 Approval Type 1 - New Molecular Entity PRIORITY
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
本品无治疗等效药品
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