药品名称NORINYL 1+50 28-DAY
申请号016659产品号001
活性成分MESTRANOL; NORETHINDRONE市场状态处方药
剂型或给药途径TABLET;ORAL-28规格0.05MG;1MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ACTAVIS LABORATORIES UT INC
化学类型New dosage form审评分类Priority review drug
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申请号修订号审批结论公开文档类型文档创建时间获取文档
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申请号修订号审批结论审批日期审批内容
016659137AP2013/10/30Manufacturing Change or Addition
016659136AP2013/12/03Manufacturing Change or Addition
016659125AP2000/01/24Labeling Revision
016659124AP1999/05/14Manufacturing Change or Addition
016659123AP1999/02/04Control Supplement
016659122AP1997/07/30Manufacturing Change or Addition
016659121AP1994/12/13Labeling Revision
016659120AP1995/08/30Labeling Revision
016659119AP1992/07/31Manufacturing Change or Addition
016659118AP1994/02/04Labeling Revision
016659117AP1991/10/09Control Supplement
016659116AP1990/09/19Control Supplement
016659115AP1990/08/15Control Supplement
016659113AP1990/11/02Labeling Revision
016659110AP1986/07/17Labeling Revision
016659109AP1985/10/25Labeling Revision
016659108AP1985/04/16Labeling Revision
016659106AP1984/11/13Manufacturing Change or Addition
016659105AP1984/07/30Labeling Revision
016659104AP1984/06/12Labeling Revision
016659102AP1984/09/27Control Supplement
016659101AP1984/05/07Labeling Revision
016659100AP1983/07/26Control Supplement
016659099AP1983/07/19Control Supplement
016659098AP1983/07/19Control Supplement
016659097AP1984/03/06Labeling Revision
016659096AP1983/07/26Control Supplement
016659095AP1983/06/13Control Supplement
016659092AP1982/07/29Control Supplement
016659089AP1982/09/07Control Supplement
016659087AP1982/01/11Control Supplement
016659082AP1979/07/18Manufacturing Change or Addition
016659079AP1979/07/18Control Supplement
016659075AP1978/11/06Control Supplement
016659074AP1978/11/06Control Supplement
016659073AP1978/05/26Control Supplement
016659061AP1977/06/14Labeling Revision
016659060AP1977/06/14Labeling Revision
016659059AP1977/06/14Labeling Revision
016659055AP1977/07/01Distributor
016659054AP1977/07/01Distributor
016659052AP1976/09/29Control Supplement
016659048AP1975/05/16Labeling Revision
016659046AP1975/05/16Control Supplement
016659043AP1975/05/16Control Supplement
016659039AP1975/05/16Control Supplement
016659037AP1975/05/16Labeling Revision
016659000AP1967/11/17Approval