药品注册申请号:074331
申请类型:ANDA (仿制药申请)
申请人:COSETTE
申请人全名:COSETTE 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 CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% No No AT 1995/12/15 1995/12/15 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
2004/03/11 SUPPL-12(补充) Approval Labeling
2002/01/23 SUPPL-10(补充) Approval Manufacturing (CMC)
2000/10/31 SUPPL-9(补充) Approval Manufacturing (CMC)
2000/10/31 SUPPL-8(补充) Approval Manufacturing (CMC)
1997/07/18 SUPPL-5(补充) Approval Manufacturing (CMC)
1997/07/18 SUPPL-3(补充) Approval Manufacturing (CMC)
1997/07/18 SUPPL-2(补充) Approval Manufacturing (CMC)
1997/05/15 SUPPL-6(补充) Approval Manufacturing (CMC)
1997/03/25 SUPPL-1(补充) Approval Manufacturing (CMC)
1995/12/15 ORIG-1(原始申请) Approval
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:CLOBETASOL PROPIONATE 剂型/给药途径:SOLUTION;TOPICAL 规格:0.05% 治疗等效代码:AT
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
074222 001 ANDA EMBELINE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Discontinued No No AT 1995/12/06 HIKMA
074331 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Discontinued No No AT 1995/12/15 COSETTE
075205 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Discontinued No No AT 1998/11/13 WOCKHARDT BIO AG
075224 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No Yes AT 1998/11/16 TARO
075391 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No No AT 1999/02/08 FOUGERA PHARMS
075363 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No No AT 2000/12/29 TARO
076977 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No No AT 2005/08/05 ENCUBE
206075 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No No AT 2015/11/23 NOVEL LABS INC
209361 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No No AT 2017/10/25 MACLEODS PHARMS LTD
210190 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No No AT 2018/04/18 GLENMARK PHARMS LTD
211494 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No No AT 2019/10/02 SAPTALIS PHARMS
212881 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No No AT 2019/10/21 ALEMBIC
213139 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Discontinued No No AT 2021/02/08 PRINSTON INC
211240 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE SOLUTION;TOPICAL 0.05% Prescription No No AT 2022/02/17 QUAGEN
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