药品注册申请号:017355
申请类型:NDA (新药申请)
申请人:TEVA BRANDED PHARM
申请人全名:TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D 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 LOESTRIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG Yes No AB 1973/04/30 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
2023/01/04 SUPPL-57(补充) Approval Labeling STANDARD
2022/04/29 SUPPL-56(补充) Approval Labeling STANDARD
2017/08/09 SUPPL-53(补充) Approval Labeling STANDARD
2014/08/05 SUPPL-48(补充) Approval Manufacturing (CMC) PRIORITY
2003/05/02 SUPPL-46(补充) Approval Labeling STANDARD
1999/11/24 SUPPL-44(补充) Approval Labeling STANDARD
1999/03/31 SUPPL-45(补充) Approval Labeling STANDARD
1999/01/08 SUPPL-43(补充) Approval Labeling STANDARD
1998/01/16 SUPPL-42(补充) Approval Labeling STANDARD
1997/11/20 SUPPL-41(补充) Approval Manufacturing (CMC) PRIORITY
1997/07/28 SUPPL-40(补充) Approval Manufacturing (CMC) PRIORITY
1997/07/28 SUPPL-39(补充) Approval Manufacturing (CMC) PRIORITY
1996/03/08 SUPPL-34(补充) Approval Labeling STANDARD
1996/03/08 SUPPL-32(补充) Approval Labeling
1995/07/07 SUPPL-38(补充) Approval Manufacturing (CMC) PRIORITY
1994/06/27 SUPPL-36(补充) Approval Manufacturing (CMC) PRIORITY
1994/06/02 SUPPL-37(补充) Approval Manufacturing (CMC) PRIORITY
1994/03/07 SUPPL-35(补充) Approval Manufacturing (CMC) PRIORITY
1993/07/09 SUPPL-33(补充) Approval Manufacturing (CMC) PRIORITY
1991/04/22 SUPPL-31(补充) Approval Manufacturing (CMC) PRIORITY
1989/05/17 SUPPL-30(补充) Approval Manufacturing (CMC) PRIORITY
1988/09/13 SUPPL-28(补充) Approval Labeling
1988/03/16 SUPPL-29(补充) Approval Manufacturing (CMC) PRIORITY
1986/10/22 SUPPL-27(补充) Approval Labeling
1986/10/22 SUPPL-26(补充) Approval Manufacturing (CMC) PRIORITY
1986/06/04 SUPPL-25(补充) Approval Labeling
1985/09/17 SUPPL-23(补充) Approval Manufacturing (CMC) PRIORITY
1984/10/22 SUPPL-24(补充) Approval Labeling
1982/11/18 SUPPL-22(补充) Approval Manufacturing (CMC) PRIORITY
1981/11/09 SUPPL-21(补充) Approval Manufacturing (CMC) PRIORITY
1981/04/06 SUPPL-20(补充) Approval Labeling
1977/02/08 SUPPL-16(补充) Approval Manufacturing (CMC) PRIORITY
1977/02/08 SUPPL-15(补充) Approval Manufacturing (CMC) PRIORITY
1975/11/14 SUPPL-12(补充) Approval Labeling
1973/04/30 ORIG-1(原始申请) Approval Type 3 - New Dosage Form PRIORITY
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 ACETATE 剂型/给药途径:TABLET;ORAL-21 规格:0.03MG;1.5MG 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
017355 001 NDA LOESTRIN FE 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG Discontinued Yes No AB Approved Prior to Jan 1, 1982 TEVA BRANDED PHARM
017875 001 NDA LOESTRIN 21 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG Discontinued Yes No AB Approved Prior to Jan 1, 1982 TEVA BRANDED PHARM
076381 001 ANDA JUNEL 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG Prescription No No AB 2003/05/30 BARR
202996 001 ANDA LARIN 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG Prescription No No AB 2014/03/20 NOVAST LABS
202770 001 ANDA NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG Prescription No No AB 2015/02/19 XIROMED
207581 001 ANDA AUROVELA 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG Prescription No No AB 2017/06/26 AUROBINDO PHARMA
209297 001 ANDA HAILEY 1.5/30 ETHINYL ESTRADIOL; NORETHINDRONE ACETATE TABLET;ORAL-21 0.03MG;1.5MG Prescription No No AB 2018/06/05 GLENMARK SPECLT
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