药品注册申请号:017443
申请类型:NDA (新药申请)
申请人:ENDO OPERATIONS
申请人全名:ENDO OPERATIONS LTD
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 DANTRIUM DANTROLENE SODIUM CAPSULE;ORAL 25MG Yes No AB 1974/01/15 Approved Prior to Jan 1, 1982 Prescription
002 DANTRIUM DANTROLENE SODIUM CAPSULE;ORAL 100MG Yes Yes AB Approved Prior to Jan 1, 1982 Prescription
003 DANTRIUM DANTROLENE SODIUM CAPSULE;ORAL 50MG Yes No AB 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
2015/07/08 SUPPL-65(补充) Approval Manufacturing (CMC) PRIORITY
2014/03/11 SUPPL-64(补充) Approval Manufacturing (CMC) PRIORITY
2012/07/17 SUPPL-49(补充) Approval Labeling STANDARD
2012/07/17 SUPPL-48(补充) Approval Labeling STANDARD
2012/07/17 SUPPL-46(补充) Approval Labeling STANDARD
2012/07/17 SUPPL-43(补充) Approval Labeling STANDARD
1997/10/30 SUPPL-47(补充) Approval Manufacturing (CMC) PRIORITY
1997/03/14 SUPPL-45(补充) Approval Manufacturing (CMC) PRIORITY
1996/09/18 SUPPL-44(补充) Approval Manufacturing (CMC) PRIORITY
1992/01/24 SUPPL-41(补充) Approval Manufacturing (CMC) PRIORITY
1991/05/20 SUPPL-40(补充) Approval Manufacturing (CMC) PRIORITY
1990/02/14 SUPPL-39(补充) Approval Manufacturing (CMC) PRIORITY
1989/06/29 SUPPL-38(补充) Approval Manufacturing (CMC) PRIORITY
1985/07/23 SUPPL-36(补充) Approval Labeling
1985/05/20 SUPPL-35(补充) Approval Manufacturing (CMC) PRIORITY
1983/11/18 SUPPL-28(补充) Approval Manufacturing (CMC) PRIORITY
1983/05/16 SUPPL-33(补充) Approval Manufacturing (CMC) PRIORITY
1983/05/16 SUPPL-32(补充) Approval Manufacturing (CMC) PRIORITY
1983/05/16 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1983/05/16 SUPPL-30(补充) Approval Manufacturing (CMC) PRIORITY
1983/05/16 SUPPL-29(补充) Approval Manufacturing (CMC) PRIORITY
1982/09/29 SUPPL-25(补充) Approval Labeling
1981/10/09 SUPPL-24(补充) Approval Labeling
1981/03/18 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1979/09/17 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1979/08/15 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
1979/08/15 SUPPL-20(补充) Approval Manufacturing (CMC) PRIORITY
1979/07/05 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1977/10/25 SUPPL-16(补充) Approval Labeling
1977/06/27 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1977/06/15 SUPPL-15(补充) Approval Labeling
1977/06/15 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1976/07/16 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1976/05/12 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1976/05/12 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1975/11/20 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1975/11/19 SUPPL-6(补充) Approval Labeling
1975/10/10 SUPPL-9(补充) Approval Labeling
1975/07/15 SUPPL-8(补充) Approval Labeling
1975/02/26 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1974/01/15 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:DANTROLENE SODIUM 剂型/给药途径:CAPSULE;ORAL 规格:25MG 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
017443 001 NDA DANTRIUM DANTROLENE SODIUM CAPSULE;ORAL 25MG Prescription Yes No AB Approved Prior to Jan 1, 1982 ENDO OPERATIONS
076856 001 ANDA DANTROLENE SODIUM DANTROLENE SODIUM CAPSULE;ORAL 25MG Prescription No No AB 2005/03/01 IMPAX LABS
076686 001 ANDA DANTROLENE SODIUM DANTROLENE SODIUM CAPSULE;ORAL 25MG Prescription No No AB 2005/10/24 ELITE LABS INC
活性成分:DANTROLENE SODIUM 剂型/给药途径:CAPSULE;ORAL 规格:100MG 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
017443 002 NDA DANTRIUM DANTROLENE SODIUM CAPSULE;ORAL 100MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 ENDO OPERATIONS
076856 003 ANDA DANTROLENE SODIUM DANTROLENE SODIUM CAPSULE;ORAL 100MG Prescription No No AB 2005/03/01 IMPAX LABS
076686 003 ANDA DANTROLENE SODIUM DANTROLENE SODIUM CAPSULE;ORAL 100MG Prescription No No AB 2005/10/24 ELITE LABS INC
活性成分:DANTROLENE SODIUM 剂型/给药途径:CAPSULE;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
017443 003 NDA DANTRIUM DANTROLENE SODIUM CAPSULE;ORAL 50MG Prescription Yes No AB Approved Prior to Jan 1, 1982 ENDO OPERATIONS
076856 002 ANDA DANTROLENE SODIUM DANTROLENE SODIUM CAPSULE;ORAL 50MG Prescription No No AB 2005/03/01 IMPAX LABS
076686 002 ANDA DANTROLENE SODIUM DANTROLENE SODIUM CAPSULE;ORAL 50MG Prescription No No AB 2005/10/24 ELITE LABS INC
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