药品注册申请号:008372
申请类型:NDA (新药申请)
申请人:MALLINCKRODT ARD
申请人全名:MALLINCKRODT ARD 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
003 ACTHAR GEL (AUTOINJECTOR) CORTICOTROPIN INJECTABLE;INJECTION 40 UNITS/0.5ML Yes Yes None 1952/04/29 2024/02/29 Prescription
004 ACTHAR GEL (AUTOINJECTOR) CORTICOTROPIN INJECTABLE;INJECTION 80 UNITS/ML Yes Yes None 2024/02/29 Prescription
006 ACTHAR GEL CORTICOTROPIN INJECTABLE;INJECTION 40 UNITS/ML No No None Approved Prior to Jan 1, 1982 Discontinued
008 ACTHAR GEL CORTICOTROPIN INJECTABLE;INJECTION 80 UNITS/ML Yes Yes None 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
2024/02/29 SUPPL-74(补充) Approval Labeling STANDARD ;Orphan
2021/10/29 SUPPL-71(补充) Approval Labeling STANDARD ;Orphan
2021/03/02 SUPPL-68(补充) Approval Labeling STANDARD ;Orphan
2019/03/26 SUPPL-61(补充) Approval Labeling STANDARD ;Orphan
2018/04/26 SUPPL-57(补充) Approval Labeling STANDARD ;Orphan
2017/07/31 SUPPL-55(补充) Approval Labeling STANDARD
2016/04/19 SUPPL-51(补充) Approval Manufacturing (CMC) STANDARD
2016/03/14 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
2016/03/11 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
2016/03/04 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
2015/03/24 SUPPL-44(补充) Approval Labeling STANDARD
2014/01/17 SUPPL-47(补充) Approval Manufacturing (CMC) STANDARD
2012/07/05 SUPPL-45(补充) Approval REMS N/A
2002/11/06 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1999/07/15 SUPPL-34(补充) Approval Manufacturing (CMC) STANDARD
1998/12/15 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1994/04/05 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1993/03/26 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1992/04/22 SUPPL-29(补充) Approval Labeling
1985/03/25 SUPPL-28(补充) Approval Manufacturing (CMC) STANDARD
1985/01/15 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1984/08/29 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1983/08/24 SUPPL-25(补充) Approval Labeling
1981/03/26 SUPPL-24(补充) Approval Labeling
1979/06/26 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1979/06/26 SUPPL-21(补充) Approval Labeling
1979/06/26 SUPPL-20(补充) Approval Labeling
1979/06/26 SUPPL-18(补充) Approval Labeling
1978/03/14 SUPPL-17(补充) Approval Labeling
1977/10/05 SUPPL-16(补充) Approval Labeling
1977/06/01 SUPPL-15(补充) Approval Labeling
1952/04/29 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer STANDARD ;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
003 11752199 2041/02/25 U-3686 U-3687 U-3688 2024/07/31 PDF格式
004 11752199 2041/02/25 U-3686 U-3687 U-3688 2024/07/31 PDF格式
008 11752199 2041/02/25 U-3686 U-3687 U-3688 2023/09/21 PDF格式
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
008 ODE 2017/10/15**本条是由Drugfuture回溯的历史信息**
与本品治疗等效的药品
本品无治疗等效药品
更多信息
药品NDC数据与药品包装、标签说明书
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