药品注册申请号:013625
申请类型:NDA (新药申请)
申请人:ACTAVIS LABS UT INC
申请人全名:ACTAVIS LABORATORIES UT 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 NORINYL 1+50 21-DAY MESTRANOL; NORETHINDRONE TABLET;ORAL-21 0.05MG;1MG No No None 1964/03/05 Approved Prior to Jan 1, 1982 Discontinued
004 NORINYL MESTRANOL; NORETHINDRONE TABLET;ORAL-20 0.1MG;2MG No No None 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
2000/01/24 SUPPL-181(补充) Approval Labeling STANDARD
1999/05/14 SUPPL-180(补充) Approval Manufacturing (CMC) STANDARD
1999/02/04 SUPPL-179(补充) Approval Manufacturing (CMC) STANDARD
1997/07/30 SUPPL-178(补充) Approval Manufacturing (CMC) STANDARD
1995/08/30 SUPPL-176(补充) Approval Labeling STANDARD
1994/12/13 SUPPL-177(补充) Approval Labeling STANDARD
1994/02/04 SUPPL-174(补充) Approval Labeling
1992/07/31 SUPPL-175(补充) Approval Manufacturing (CMC) STANDARD
1991/10/09 SUPPL-173(补充) Approval Manufacturing (CMC) STANDARD
1990/11/02 SUPPL-169(补充) Approval Labeling
1990/09/19 SUPPL-172(补充) Approval Manufacturing (CMC) STANDARD
1990/08/06 SUPPL-171(补充) Approval Manufacturing (CMC) STANDARD
1986/10/22 SUPPL-166(补充) Approval Labeling
1986/07/17 SUPPL-165(补充) Approval Labeling
1985/10/25 SUPPL-164(补充) Approval Labeling
1985/10/25 SUPPL-163(补充) Approval Labeling
1985/06/19 SUPPL-162(补充) Approval Labeling
1985/04/16 SUPPL-161(补充) Approval Labeling
1984/11/13 SUPPL-159(补充) Approval Manufacturing (CMC) STANDARD
1984/09/27 SUPPL-155(补充) Approval Manufacturing (CMC) STANDARD
1984/07/30 SUPPL-158(补充) Approval Labeling
1984/06/12 SUPPL-157(补充) Approval Labeling
1984/05/07 SUPPL-154(补充) Approval Labeling
1984/03/06 SUPPL-50(补充) Approval Labeling
1983/07/26 SUPPL-53(补充) Approval Manufacturing (CMC) STANDARD
1983/07/26 SUPPL-49(补充) Approval Manufacturing (CMC) STANDARD
1983/07/19 SUPPL-52(补充) Approval Manufacturing (CMC) STANDARD
1983/07/19 SUPPL-51(补充) Approval Manufacturing (CMC) STANDARD
1983/06/13 SUPPL-48(补充) Approval Manufacturing (CMC) STANDARD
1982/09/07 SUPPL-42(补充) Approval Manufacturing (CMC) STANDARD
1982/07/29 SUPPL-145(补充) Approval Manufacturing (CMC) STANDARD
1982/01/11 SUPPL-40(补充) Approval Manufacturing (CMC) STANDARD
1979/07/18 SUPPL-133(补充) Approval Manufacturing (CMC) STANDARD
1979/07/18 SUPPL-130(补充) Approval Manufacturing (CMC) STANDARD
1979/07/18 SUPPL-129(补充) Approval Manufacturing (CMC) STANDARD
1979/07/18 SUPPL-128(补充) Approval Manufacturing (CMC) STANDARD
1978/11/06 SUPPL-127(补充) Approval Manufacturing (CMC) STANDARD
1978/11/06 SUPPL-126(补充) Approval Manufacturing (CMC) STANDARD
1978/05/26 SUPPL-125(补充) Approval Manufacturing (CMC) STANDARD
1977/11/22 SUPPL-104(补充) Approval Labeling
1977/11/22 SUPPL-103(补充) Approval Labeling
1977/07/01 SUPPL-85(补充) Approval Labeling
1977/06/14 SUPPL-100(补充) Approval Labeling
1977/06/14 SUPPL-99(补充) Approval Labeling
1977/06/14 SUPPL-98(补充) Approval Labeling
1977/06/14 SUPPL-95(补充) Approval Labeling
1977/06/14 SUPPL-92(补充) Approval Labeling
1977/05/26 SUPPL-97(补充) Approval Labeling
1977/05/26 SUPPL-96(补充) Approval Labeling
1977/05/26 SUPPL-87(补充) Approval Labeling
1977/05/26 SUPPL-86(补充) Approval Labeling
1975/05/16 SUPPL-82(补充) Approval Labeling
1975/05/16 SUPPL-80(补充) Approval Manufacturing (CMC) STANDARD
1975/05/16 SUPPL-78(补充) Approval Manufacturing (CMC) STANDARD
1975/05/16 SUPPL-74(补充) Approval Manufacturing (CMC) STANDARD
1975/05/16 SUPPL-72(补充) Approval Labeling
1964/03/05 ORIG-1(原始申请) Approval Type 5 - New Formulation or New Manufacturer 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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