药品注册申请号:016295
申请类型:NDA (新药申请)
申请人:CHEPLAPHARM
申请人全名:CHEPLAPHARM ARZNEIMITTEL GMBH
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 HYDREA HYDROXYUREA CAPSULE;ORAL 500MG Yes Yes AB 1967/12/07 Approved Prior to Jan 1, 1982 Prescription
002 DROXIA HYDROXYUREA CAPSULE;ORAL 200MG Yes No None 1998/02/25 Prescription
003 DROXIA HYDROXYUREA CAPSULE;ORAL 300MG Yes No None 1998/02/25 Prescription
004 DROXIA HYDROXYUREA CAPSULE;ORAL 400MG Yes No None 1998/02/25 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
2023/11/28 SUPPL-58(补充) Approval Labeling STANDARD
2023/06/07 SUPPL-57(补充) Approval Labeling STANDARD
2022/01/13 SUPPL-56(补充) Approval Labeling STANDARD
2021/08/05 SUPPL-55(补充) Approval Labeling STANDARD
2021/02/09 SUPPL-54(补充) Approval Labeling STANDARD
2019/12/18 SUPPL-52(补充) Approval Labeling STANDARD
2019/07/22 SUPPL-51(补充) Approval Labeling STANDARD Label for DROXIA includes a Medication Guide
2017/12/18 SUPPL-50(补充) Approval Labeling STANDARD ;Orphan
2017/12/18 SUPPL-49(补充) Approval Labeling STANDARD ;Orphan
2016/03/23 SUPPL-48(补充) Approval Labeling STANDARD
2016/03/23 SUPPL-47(补充) Approval Labeling STANDARD
2015/07/16 SUPPL-46(补充) Approval Labeling STANDARD
2015/07/16 SUPPL-45(补充) Approval Labeling STANDARD
2012/01/26 SUPPL-42(补充) Approval Labeling UNKNOWN
2012/01/26 SUPPL-41(补充) Approval Labeling STANDARD
2010/05/07 SUPPL-40(补充) Approval Labeling STANDARD
2006/09/19 SUPPL-39(补充) Approval Labeling STANDARD
2004/02/19 SUPPL-37(补充) Approval Labeling STANDARD
2003/06/26 SUPPL-36(补充) Approval Efficacy STANDARD
2001/04/04 SUPPL-34(补充) Approval Labeling STANDARD
2001/02/20 SUPPL-35(补充) Approval Labeling STANDARD
2000/01/12 SUPPL-33(补充) Approval Labeling STANDARD
1999/08/11 SUPPL-26(补充) Approval Labeling STANDARD
1998/11/10 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1998/02/25 SUPPL-30(补充) Approval Manufacturing (CMC) PRIORITY
1998/02/25 SUPPL-29(补充) Approval Efficacy PRIORITY
1997/05/23 SUPPL-28(补充) Approval Manufacturing (CMC) PRIORITY
1997/04/07 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
1996/11/25 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
1996/10/15 SUPPL-24(补充) Approval Manufacturing (CMC) PRIORITY
1996/09/24 SUPPL-23(补充) Approval Labeling STANDARD
1996/09/24 SUPPL-11(补充) Approval Labeling
1995/09/05 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1993/03/09 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1992/07/31 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1988/08/25 SUPPL-18(补充) Approval Manufacturing (CMC) PRIORITY
1988/05/10 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1987/03/19 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1987/03/19 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1985/07/16 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
1980/02/19 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1977/05/03 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
1967/12/07 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:HYDROXYUREA 剂型/给药途径:CAPSULE;ORAL 规格:500MG 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
016295 001 NDA HYDREA HYDROXYUREA CAPSULE;ORAL 500MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 CHEPLAPHARM
075143 001 ANDA HYDROXYUREA HYDROXYUREA CAPSULE;ORAL 500MG Prescription No No AB 1998/10/16 BARR
075340 001 ANDA HYDROXYUREA HYDROXYUREA CAPSULE;ORAL 500MG Prescription No No AB 1999/02/24 PAR PHARM
213438 001 ANDA HYDROXYUREA HYDROXYUREA CAPSULE;ORAL 500MG Prescription No No AB 2020/04/08 LEADING
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