药品注册申请号:019190
申请类型:NDA (新药申请)
申请人:WYETH PHARMS INC
申请人全名:WYETH 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
001 TRIPHASIL-28 ETHINYL ESTRADIOL; LEVONORGESTREL TABLET;ORAL-28 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 1984/11/01 1984/11/01 Discontinued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
2022/04/29 SUPPL-50(补充) Approval Labeling STANDARD
2019/05/08 SUPPL-49(补充) Approval Labeling STANDARD
2017/08/09 SUPPL-48(补充) Approval Labeling STANDARD
2002/03/06 SUPPL-38(补充) Approval Manufacturing (CMC) STANDARD
2000/03/23 SUPPL-36(补充) Approval Labeling STANDARD
2000/02/02 SUPPL-34(补充) Approval Labeling STANDARD
1998/12/11 SUPPL-35(补充) Approval Manufacturing (CMC) STANDARD
1998/03/11 SUPPL-33(补充) Approval Manufacturing (CMC) STANDARD
1997/08/25 SUPPL-32(补充) Approval Manufacturing (CMC) STANDARD
1996/05/17 SUPPL-31(补充) Approval Manufacturing (CMC) STANDARD
1995/10/11 SUPPL-30(补充) Approval Manufacturing (CMC) STANDARD
1995/05/03 SUPPL-29(补充) Approval Labeling STANDARD
1995/05/03 SUPPL-28(补充) Approval Labeling STANDARD
1994/05/27 SUPPL-27(补充) Approval Manufacturing (CMC) STANDARD
1994/04/08 SUPPL-26(补充) Approval Manufacturing (CMC) STANDARD
1993/10/04 SUPPL-25(补充) Approval Labeling STANDARD
1993/04/29 SUPPL-23(补充) Approval Labeling
1993/03/09 SUPPL-24(补充) Approval Manufacturing (CMC) STANDARD
1992/06/10 SUPPL-22(补充) Approval Manufacturing (CMC) STANDARD
1991/10/07 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
1991/08/15 SUPPL-14(补充) Approval Manufacturing (CMC) STANDARD
1991/05/20 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
1991/05/03 SUPPL-20(补充) Approval Manufacturing (CMC) STANDARD
1990/08/08 SUPPL-12(补充) Approval Labeling
1990/05/30 SUPPL-19(补充) Approval Labeling
1990/05/15 SUPPL-18(补充) Approval Manufacturing (CMC) STANDARD
1990/01/18 SUPPL-17(补充) Approval Manufacturing (CMC) STANDARD
1989/05/19 SUPPL-16(补充) Approval Manufacturing (CMC) STANDARD
1988/04/27 SUPPL-13(补充) Approval Manufacturing (CMC) STANDARD
1987/10/27 SUPPL-11(补充) Approval Manufacturing (CMC) STANDARD
1987/05/15 SUPPL-9(补充) Approval Manufacturing (CMC) STANDARD
1986/09/25 SUPPL-8(补充) Approval Manufacturing (CMC) STANDARD
1986/07/15 SUPPL-7(补充) Approval Labeling
1986/05/28 SUPPL-4(补充) Approval Manufacturing (CMC) STANDARD
1986/05/12 SUPPL-5(补充) Approval Manufacturing (CMC) STANDARD
1985/12/20 SUPPL-3(补充) Approval Labeling
1985/09/06 SUPPL-2(补充) Approval Labeling
1985/07/29 SUPPL-1(补充) Approval Manufacturing (CMC) STANDARD
1984/11/01 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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