药品注册申请号:018662
申请类型:NDA (新药申请)
申请人:HOFFMANN LA ROCHE
申请人全名:HOFFMANN LA ROCHE 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
002 ACCUTANE ISOTRETINOIN CAPSULE;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/05/07 1982/05/07 Discontinued
003 ACCUTANE ISOTRETINOIN CAPSULE;ORAL 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1982/05/07 Discontinued
004 ACCUTANE ISOTRETINOIN CAPSULE;ORAL 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1983/03/28 Discontinued
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
2010/10/22 SUPPL-61(补充) Approval Labeling PRIORITY
2010/02/01 SUPPL-60(补充) Approval Labeling PRIORITY
2008/11/19 SUPPL-59(补充) Approval Labeling PRIORITY
2007/10/03 SUPPL-58(补充) Approval Labeling PRIORITY
2006/01/13 SUPPL-57(补充) Approval Supplement PRIORITY
2005/08/12 SUPPL-56(补充) Approval Labeling PRIORITY
2005/08/10 SUPPL-55(补充) Approval Supplement PRIORITY
2004/08/24 SUPPL-54(补充) Approval Labeling PRIORITY
2004/03/26 SUPPL-53(补充) Approval Manufacturing (CMC) PRIORITY
2003/08/27 SUPPL-52(补充) Approval Labeling PRIORITY
2003/08/27 SUPPL-48(补充) Approval Labeling PRIORITY
2002/06/20 SUPPL-51(补充) Approval Labeling PRIORITY
2002/05/02 SUPPL-43(补充) Approval Efficacy PRIORITY
2002/04/12 SUPPL-47(补充) Approval Labeling PRIORITY
2002/02/15 SUPPL-46(补充) Approval Labeling PRIORITY
2001/12/31 SUPPL-45(补充) Approval Labeling PRIORITY
2001/12/31 SUPPL-41(补充) Approval Labeling PRIORITY
2001/10/30 SUPPL-44(补充) Approval Labeling PRIORITY
2001/01/11 SUPPL-42(补充) Approval Manufacturing (CMC) PRIORITY
2000/05/01 SUPPL-40(补充) Approval Labeling PRIORITY
2000/05/01 SUPPL-39(补充) Approval Labeling PRIORITY
2000/05/01 SUPPL-38(补充) Approval Labeling PRIORITY
1999/04/30 SUPPL-37(补充) Approval Manufacturing (CMC) PRIORITY
1995/05/17 SUPPL-34(补充) Approval Labeling PRIORITY
1994/01/13 SUPPL-33(补充) Approval Labeling PRIORITY
1991/10/08 SUPPL-32(补充) Approval Manufacturing (CMC) PRIORITY
1991/03/07 SUPPL-30(补充) Approval Labeling PRIORITY
1990/10/16 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1990/04/16 SUPPL-29(补充) Approval Labeling PRIORITY
1989/08/09 SUPPL-28(补充) Approval Manufacturing (CMC) PRIORITY
1989/04/28 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1989/04/04 SUPPL-27(补充) Approval Manufacturing (CMC) PRIORITY
1988/11/16 SUPPL-25(补充) Approval Manufacturing (CMC) PRIORITY
1988/08/26 SUPPL-24(补充) Approval Labeling PRIORITY
1988/01/07 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1987/10/19 SUPPL-22(补充) Approval Labeling PRIORITY
1987/06/03 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
1987/06/01 SUPPL-20(补充) Approval Labeling PRIORITY
1987/02/26 SUPPL-19(补充) Approval Manufacturing (CMC) PRIORITY
1986/06/06 SUPPL-18(补充) Approval Labeling PRIORITY
1986/06/06 SUPPL-17(补充) Approval Labeling PRIORITY
1986/06/06 SUPPL-14(补充) Approval Efficacy PRIORITY
1986/06/06 SUPPL-10(补充) Approval Labeling PRIORITY
1986/06/06 SUPPL-3(补充) Approval Labeling PRIORITY
1986/06/06 SUPPL-1(补充) Approval Labeling PRIORITY
1985/07/05 SUPPL-16(补充) Approval Labeling PRIORITY
1985/06/19 SUPPL-7(补充) Approval Manufacturing (CMC) PRIORITY
1985/04/30 SUPPL-15(补充) Approval Labeling PRIORITY
1984/11/27 SUPPL-13(补充) Approval Manufacturing (CMC) PRIORITY
1984/11/01 SUPPL-11(补充) Approval Manufacturing (CMC) PRIORITY
1984/05/31 SUPPL-9(补充) Approval Manufacturing (CMC) PRIORITY
1984/02/28 SUPPL-8(补充) Approval Labeling PRIORITY
1983/08/09 SUPPL-4(补充) Approval Labeling PRIORITY
1983/06/30 SUPPL-2(补充) Approval Manufacturing (CMC) PRIORITY
1982/05/07 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
本品无治疗等效药品
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