药品注册申请号:017919
申请类型:NDA (新药申请)
申请人:JANSSEN PHARMS
申请人全名:JANSSEN PHARMACEUTICALS 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 ORTHO-NOVUM 1/35-28 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1977/06/23 Approved Prior to Jan 1, 1982 Discontinued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
2017/08/09 SUPPL-100(补充) Approval Labeling STANDARD
2015/10/29 SUPPL-99(补充) Approval Labeling STANDARD
2014/09/11 SUPPL-98(补充) Approval Manufacturing (CMC) STANDARD
2013/10/03 SUPPL-86(补充) Approval Labeling STANDARD
2013/10/02 SUPPL-96(补充) Approval Labeling STANDARD
2013/10/02 SUPPL-92(补充) Approval Labeling STANDARD
2013/10/02 SUPPL-90(补充) Approval Labeling STANDARD
2012/06/18 SUPPL-89(补充) Approval Labeling STANDARD
2002/06/03 SUPPL-75(补充) Approval Manufacturing (CMC) STANDARD
2002/02/21 SUPPL-74(补充) Approval Manufacturing (CMC) STANDARD
2001/07/09 SUPPL-73(补充) Approval Manufacturing (CMC) STANDARD
2000/06/06 SUPPL-71(补充) Approval Labeling STANDARD
2000/01/05 SUPPL-70(补充) Approval Manufacturing (CMC) STANDARD
1999/08/27 SUPPL-69(补充) Approval Labeling STANDARD
1999/08/27 SUPPL-65(补充) Approval Labeling STANDARD
1999/01/06 SUPPL-66(补充) Approval Labeling STANDARD
1998/04/28 SUPPL-68(补充) Approval Manufacturing (CMC) STANDARD
1998/04/13 SUPPL-67(补充) Approval Manufacturing (CMC) STANDARD
1997/02/24 SUPPL-64(补充) Approval Manufacturing (CMC) STANDARD
1997/01/29 SUPPL-63(补充) Approval Manufacturing (CMC) STANDARD
1996/05/10 SUPPL-61(补充) Approval Manufacturing (CMC) STANDARD
1996/04/09 SUPPL-62(补充) Approval Manufacturing (CMC) STANDARD
1995/11/30 SUPPL-60(补充) Approval Manufacturing (CMC) STANDARD
1995/09/07 SUPPL-59(补充) Approval Manufacturing (CMC) STANDARD
1995/02/16 SUPPL-58(补充) Approval Manufacturing (CMC) STANDARD
1994/03/07 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1994/01/04 SUPPL-56(补充) Approval Labeling STANDARD
1993/11/04 SUPPL-57(补充) Approval Manufacturing (CMC) STANDARD
1993/05/18 SUPPL-55(补充) Approval Manufacturing (CMC) STANDARD
1991/09/16 SUPPL-49(补充) Approval Labeling
1991/03/18 SUPPL-50(补充) Approval Manufacturing (CMC) STANDARD
1990/01/18 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1989/10/23 SUPPL-46(补充) Approval Labeling
1989/07/19 SUPPL-45(补充) Approval Labeling
1988/10/28 SUPPL-44(补充) Approval Manufacturing (CMC) STANDARD
1988/09/09 SUPPL-42(补充) Approval Labeling
1988/06/08 SUPPL-43(补充) Approval Manufacturing (CMC) STANDARD
1987/11/23 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1987/02/26 SUPPL-41(补充) Approval Labeling
1985/10/21 SUPPL-38(补充) Approval Labeling
1985/04/05 SUPPL-37(补充) Approval Labeling
1984/06/21 SUPPL-36(补充) Approval Labeling
1984/01/30 SUPPL-35(补充) Approval Labeling
1983/09/29 SUPPL-34(补充) Approval Labeling
1983/06/15 SUPPL-32(补充) Approval Labeling
1983/06/09 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1982/09/29 SUPPL-29(补充) Approval Labeling
1980/11/12 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1980/11/12 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
1980/08/21 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
1980/07/29 SUPPL-4(补充) Approval Labeling
1980/03/24 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1979/12/05 SUPPL-21(补充) Approval Labeling
1979/12/05 SUPPL-20(补充) Approval Labeling
1979/11/08 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
1979/10/19 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1979/06/19 SUPPL-10(补充) Approval Manufacturing (CMC) STANDARD
1978/07/31 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1978/05/25 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1978/04/17 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1978/03/29 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1978/02/28 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1978/02/28 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1978/02/28 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
1977/10/20 SUPPL-2(补充) Approval Manufacturing (CMC) STANDARD
1977/06/23 ORIG-1(原始申请) Approval Type 3 - New Dosage Form STANDARD
与本品相关的专利信息(来自FDA橙皮书Orange Book)
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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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