药品注册申请号:020049
申请类型:NDA (新药申请)
申请人:TAKEDA PHARMS USA
申请人全名:TAKEDA PHARMACEUTICALS USA 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 PENTASA MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 250MG Yes No None 1993/05/10 1993/05/10 Prescription
002 PENTASA MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 500MG Yes Yes AB 2004/07/08 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
2022/11/16 SUPPL-38(补充) Approval Labeling STANDARD
2021/11/01 SUPPL-36(补充) Approval Labeling STANDARD
2021/05/25 SUPPL-35(补充) Approval Labeling STANDARD
2020/10/29 SUPPL-34(补充) Approval Labeling STANDARD
2020/10/01 SUPPL-33(补充) Approval Labeling STANDARD
2019/07/16 SUPPL-32(补充) Approval Labeling STANDARD
2018/05/30 SUPPL-31(补充) Approval Labeling STANDARD
2017/08/22 SUPPL-28(补充) Approval Labeling STANDARD
2017/07/27 SUPPL-30(补充) Approval Labeling STANDARD
2015/08/05 SUPPL-27(补充) Approval Labeling STANDARD
2013/12/16 SUPPL-26(补充) Approval Labeling STANDARD
2013/07/23 SUPPL-25(补充) Approval Labeling STANDARD
2007/06/26 SUPPL-19(补充) Approval Labeling STANDARD
2006/06/27 SUPPL-17(补充) Approval Labeling STANDARD
2004/07/08 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
2002/09/03 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
2000/10/12 SUPPL-8(补充) Approval Manufacturing (CMC) PRIORITY
2000/08/24 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1999/09/10 SUPPL-6(补充) Approval Labeling STANDARD
1998/08/05 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1998/03/19 SUPPL-4(补充) Approval Manufacturing (CMC) PRIORITY
1998/02/19 SUPPL-3(补充) Approval Manufacturing (CMC) PRIORITY
1997/10/29 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1996/03/11 SUPPL-1(补充) Approval Labeling STANDARD
1993/05/10 ORIG-1(原始申请) Approval Type 3 - New Dosage Form 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:MESALAMINE 剂型/给药途径:CAPSULE, EXTENDED RELEASE;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
020049 002 NDA PENTASA MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 500MG Prescription Yes Yes AB 2004/07/08 TAKEDA PHARMS USA
214585 001 ANDA MESALAMINE MESALAMINE CAPSULE, EXTENDED RELEASE;ORAL 500MG Prescription No No AB 2022/05/11 SUN PHARM
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