药品注册申请号:050722
申请类型:NDA (新药申请)
申请人:ROCHE PALO
申请人全名:ROCHE PALO ALTO LLC
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 CELLCEPT MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Yes Yes AB 1995/05/03 1995/05/03 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
2024/08/13 SUPPL-53(补充) Approval REMS N/A
2022/08/10 SUPPL-50(补充) Approval Labeling STANDARD
2022/06/06 SUPPL-51(补充) Approval Efficacy STANDARD
2022/06/06 SUPPL-49(补充) Approval Efficacy STANDARD
2021/10/22 SUPPL-46(补充) Approval Labeling STANDARD
2021/10/22 SUPPL-45(补充) Approval Labeling STANDARD
2021/08/11 SUPPL-48(补充) Approval REMS N/A
2021/04/21 SUPPL-47(补充) Approval REMS N/A
2021/01/15 SUPPL-44(补充) Approval REMS N/A
2019/12/13 SUPPL-40(补充) Approval Labeling STANDARD
2019/02/27 SUPPL-38(补充) Approval Labeling STANDARD
2018/08/23 SUPPL-35(补充) Approval Labeling STANDARD
2017/12/18 SUPPL-37(补充) Approval Labeling STANDARD
2015/11/13 SUPPL-34(补充) Approval REMS N/A
2015/07/09 SUPPL-33(补充) Approval Labeling STANDARD
2014/01/23 SUPPL-32(补充) Approval Manufacturing (CMC) PRIORITY
2013/09/27 SUPPL-31(补充) Approval REMS N/A
2013/09/27 SUPPL-30(补充) Approval Labeling STANDARD
2013/02/14 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
2012/09/25 SUPPL-22(补充) Approval Labeling STANDARD
2012/06/22 SUPPL-28(补充) Approval Labeling STANDARD
2012/06/08 SUPPL-26(补充) Approval Labeling STANDARD
2009/10/08 SUPPL-24(补充) Approval Labeling 901 REQUIRED
2009/06/18 SUPPL-21(补充) Approval Labeling STANDARD
2009/02/27 SUPPL-20(补充) Approval Labeling STANDARD
2008/12/15 SUPPL-19(补充) Approval Labeling STANDARD
2008/05/09 SUPPL-18(补充) Approval Labeling STANDARD
2007/12/20 SUPPL-15(补充) Approval Labeling STANDARD
2007/09/21 SUPPL-16(补充) Approval Labeling STANDARD
2005/10/17 SUPPL-13(补充) Approval Labeling STANDARD
2003/02/28 SUPPL-8(补充) Approval Labeling STANDARD
2002/05/31 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
2001/11/14 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
2000/12/20 SUPPL-7(补充) Approval Efficacy STANDARD
2000/07/28 SUPPL-5(补充) Approval Efficacy STANDARD
2000/07/27 SUPPL-4(补充) Approval Labeling STANDARD
2000/05/15 SUPPL-6(补充) Approval Manufacturing (CMC) PRIORITY
1998/04/13 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1998/02/11 SUPPL-2(补充) Approval Efficacy STANDARD
1997/06/12 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY
1995/05/03 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
001 4753935 2009/05/03 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
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:MYCOPHENOLATE MOFETIL 剂型/给药途径:CAPSULE;ORAL 规格:250MG 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
050722 001 NDA CELLCEPT MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription Yes Yes AB 1995/05/03 ROCHE PALO
065410 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2008/07/29 HIKMA
065379 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2008/10/15 SANDOZ
090253 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2009/05/04 ACCORD HLTHCARE
065520 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2009/05/04 MYLAN
065491 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2009/05/06 TEVA PHARMS
090055 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2010/06/10 STRIDES PHARMA
200197 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2013/06/13 ALKEM LABS LTD
204077 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2017/11/13 ZHEJIANG HISUN PHARM
210181 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2019/01/08 CONCORD BIOTECH LTD
217828 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2024/01/05 AUROBINDO PHARMA LTD
207022 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2024/10/22 HETERO LABS LTD V
214079 001 ANDA MYCOPHENOLATE MOFETIL MYCOPHENOLATE MOFETIL CAPSULE;ORAL 250MG Prescription No No AB 2024/11/07 WUXI
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