药品注册申请号:009053
申请类型:NDA (新药申请)
申请人:STASON PHARMS
申请人全名:STASON PHARMACEUTICALS 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 PURINETHOL MERCAPTOPURINE TABLET;ORAL 50MG Yes No AB 1953/09/11 Approved Prior to Jan 1, 1982 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
2020/12/29 SUPPL-40(补充) Approval Labeling STANDARD
2020/04/29 SUPPL-39(补充) Approval Labeling STANDARD
2018/05/23 SUPPL-35(补充) Approval Labeling STANDARD
2011/05/27 SUPPL-32(补充) Approval Labeling 901 REQUIRED
2004/07/15 SUPPL-24(补充) Approval Labeling STANDARD
2003/01/10 SUPPL-22(补充) Approval Labeling STANDARD
2002/09/06 SUPPL-21(补充) Approval Labeling STANDARD
2002/03/22 SUPPL-20(补充) Approval Labeling STANDARD
2001/05/16 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
2001/04/03 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1996/04/15 SUPPL-18(补充) Approval Labeling STANDARD
1987/11/17 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1987/05/20 SUPPL-14(补充) Approval Labeling
1987/04/09 SUPPL-13(补充) Approval Labeling
1986/10/14 SUPPL-9(补充) Approval Labeling
1986/09/23 SUPPL-12(补充) Approval Labeling
1985/11/20 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1982/10/19 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1979/12/19 SUPPL-7(补充) Approval Labeling
1977/02/15 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1953/09/11 ORIG-1(原始申请) 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
活性成分:MERCAPTOPURINE 剂型/给药途径:TABLET;ORAL 规格:50MG 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
009053 002 NDA PURINETHOL MERCAPTOPURINE TABLET;ORAL 50MG Prescription Yes No AB Approved Prior to Jan 1, 1982 STASON PHARMS
040461 001 ANDA MERCAPTOPURINE MERCAPTOPURINE TABLET;ORAL 50MG Prescription No No AB 2004/02/11 DR REDDYS LABS SA
040528 001 ANDA MERCAPTOPURINE MERCAPTOPURINE TABLET;ORAL 50MG Prescription No Yes AB 2004/02/13 HIKMA
040594 001 ANDA MERCAPTOPURINE MERCAPTOPURINE TABLET;ORAL 50MG Prescription No No AB 2005/07/01 MYLAN
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药品NDC数据与药品包装、标签说明书
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