药品注册申请号:018985
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
001 ORTHO-NOVUM 7/7/7-21 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-21 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG No No None 1984/04/04 1984/04/04 Discontinued
002 ORTHO-NOVUM 7/7/7-28 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Yes Yes AB 1984/04/04 Prescription
批准历史,通知信,药品说明书,综述等审批信息
批准日期申请类型申请提交号审查批准结论申请内容分类审评分类(优先审评;罕用药状态)通知信、综述、标签、说明书备注
2017/08/09 SUPPL 64 Approval Labeling STANDARD
2015/10/29 SUPPL 63 Approval Labeling STANDARD
2014/09/11 SUPPL 62 Approval Manufacturing (CMC) STANDARD
2013/10/03 SUPPL 50 Approval Labeling STANDARD
2013/10/02 SUPPL 60 Approval Labeling STANDARD
2013/10/02 SUPPL 56 Approval Labeling STANDARD
2013/10/02 SUPPL 54 Approval Labeling STANDARD
2012/06/18 SUPPL 53 Approval Labeling STANDARD
2002/06/03 SUPPL 39 Approval Manufacturing (CMC) STANDARD
2002/02/21 SUPPL 38 Approval Manufacturing (CMC) STANDARD
2001/07/09 SUPPL 37 Approval Manufacturing (CMC) STANDARD
2000/06/06 SUPPL 35 Approval Labeling STANDARD
2000/01/05 SUPPL 34 Approval Manufacturing (CMC) STANDARD
1999/08/27 SUPPL 33 Approval Labeling STANDARD
1999/08/27 SUPPL 30 Approval Labeling STANDARD
1999/08/27 SUPPL 29 Approval Labeling STANDARD
1998/04/28 SUPPL 32 Approval Manufacturing (CMC) STANDARD
1998/04/13 SUPPL 31 Approval Manufacturing (CMC) STANDARD
1997/02/24 SUPPL 28 Approval Manufacturing (CMC) STANDARD
1997/01/29 SUPPL 27 Approval Manufacturing (CMC) STANDARD
1996/05/10 SUPPL 25 Approval Manufacturing (CMC) STANDARD
1996/04/09 SUPPL 26 Approval Manufacturing (CMC) STANDARD
1995/11/30 SUPPL 24 Approval Manufacturing (CMC) STANDARD
1995/09/07 SUPPL 23 Approval Manufacturing (CMC) STANDARD
1995/02/16 SUPPL 22 Approval Manufacturing (CMC) STANDARD
1994/03/07 SUPPL 17 Approval Manufacturing (CMC) STANDARD
1994/01/03 SUPPL 20 Approval Labeling STANDARD
1993/11/04 SUPPL 21 Approval Manufacturing (CMC) STANDARD
1993/05/18 SUPPL 19 Approval Manufacturing (CMC) STANDARD
1991/09/16 SUPPL 14 Approval Labeling
1991/03/18 SUPPL 15 Approval Manufacturing (CMC) STANDARD
1990/01/18 SUPPL 13 Approval Manufacturing (CMC) STANDARD
1989/10/23 SUPPL 11 Approval Labeling
1989/07/19 SUPPL 10 Approval Labeling
1988/10/28 SUPPL 9 Approval Manufacturing (CMC) STANDARD
1988/09/09 SUPPL 7 Approval Labeling
1988/06/08 SUPPL 8 Approval Manufacturing (CMC) STANDARD
1987/11/23 SUPPL 5 Approval Manufacturing (CMC) STANDARD
1987/02/02 SUPPL 6 Approval Labeling
1985/10/21 SUPPL 3 Approval Labeling
1985/04/05 SUPPL 2 Approval Labeling
1984/06/21 SUPPL 1 Approval Labeling
1984/04/04 ORIG 1 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)
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
活性成分:ETHINYL ESTRADIOL; NORETHINDRONE 剂型/给药途径:TABLET;ORAL-28 规格:0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG 治疗等效代码:AB
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
018985 002 NDA ORTHO-NOVUM 7/7/7-28 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription Yes Yes AB 1984/04/04 JANSSEN PHARMS
075478 002 ANDA NORTREL 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2002/08/30 BARR
076338 001 ANDA CYCLAFEM 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2010/11/16 VINTAGE PHARMS LLC
090946 001 ANDA DASETTA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2011/12/22 NOVAST LABS LTD
091636 001 ANDA ALYACEN 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2012/01/19 GLENMARK GENERICS
201510 001 ANDA PIRMELLA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2013/04/24 LUPIN LTD
207054 001 ANDA NYLIA 7/7/7 ETHINYL ESTRADIOL; NORETHINDRONE TABLET;ORAL-28 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Prescription No No AB 2016/10/21 AUROBINDO PHARMA LTD
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