药品注册申请号:018264
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 INJECTABLE;INJECTION 20MG/VIAL Yes Yes AP 1979/09/19 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
2024/04/02 SUPPL-42(补充) Approval Labeling STANDARD
2008/10/09 SUPPL-25(补充) Approval Labeling STANDARD
2001/10/01 SUPPL-22(补充) Approval Labeling STANDARD
2001/07/12 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
2000/08/18 SUPPL-19(补充) Approval Labeling STANDARD
1989/06/28 SUPPL-15(补充) Approval Labeling
1989/02/21 SUPPL-17(补充) Approval Manufacturing (CMC) PRIORITY
1988/06/28 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1987/12/11 SUPPL-14(补充) Approval Manufacturing (CMC) PRIORITY
1987/06/04 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1987/05/12 SUPPL-11(补充) Approval Efficacy
1987/05/12 SUPPL-8(补充) Approval Labeling
1986/02/15 SUPPL-9(补充) Approval Labeling
1985/08/07 SUPPL-12(补充) Approval Manufacturing (CMC) PRIORITY
1985/08/06 SUPPL-10(补充) Approval Manufacturing (CMC) PRIORITY
1982/02/26 SUPPL-3(补充) Approval Efficacy
1982/02/12 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1981/10/01 SUPPL-6(补充) Approval Labeling
1981/05/30 SUPPL-5(补充) Approval Manufacturing (CMC) PRIORITY
1981/01/14 SUPPL-4(补充) Approval Labeling
1980/06/16 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1980/02/07 SUPPL-1(补充) Approval Manufacturing (CMC) PRIORITY ;Orphan
1979/09/19 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY ;Orphan
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:INJECTABLE;INJECTION 规格:20MG/VIAL 治疗等效代码:AP
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
018264 001 NDA DANTRIUM DANTROLENE SODIUM INJECTABLE;INJECTION 20MG/VIAL Prescription Yes Yes AP Approved Prior to Jan 1, 1982 ENDO OPERATIONS
078378 001 ANDA REVONTO DANTROLENE SODIUM INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2007/07/24 USWM
204762 001 ANDA DANTROLENE SODIUM DANTROLENE SODIUM INJECTABLE;INJECTION 20MG/VIAL Prescription No No AP 2017/06/19 HIKMA
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