药品注册申请号:074220
申请类型:ANDA (仿制药申请)
申请人:HIKMA
申请人全名:HIKMA PHARMACEUTICALS USA 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 CORMAX CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% No No AB1 1997/05/16 1997/05/16 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
2018/09/26 SUPPL-10(补充) Approval Manufacturing (CMC)
2001/02/21 SUPPL-7(补充) Approval Manufacturing (CMC)
2000/10/23 SUPPL-6(补充) Approval Manufacturing (CMC)
1998/12/07 SUPPL-4(补充) Approval Manufacturing (CMC)
1998/04/28 SUPPL-3(补充) Approval Labeling
1998/04/28 SUPPL-2(补充) Approval Manufacturing (CMC)
1998/04/28 SUPPL-1(补充) Approval Manufacturing (CMC)
1997/05/16 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:CREAM;TOPICAL 规格:0.05% 治疗等效代码:AB1
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
074139 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Discontinued No No AB1 1994/08/03 COSETTE
074249 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 1996/07/08 TARO
074392 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 1996/09/30 FOUGERA PHARMS INC
074220 001 ANDA CORMAX CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Discontinued No No AB1 1997/05/16 HIKMA
075338 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 2001/02/09 AUROBINDO PHARMA USA
210208 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 2018/01/30 LUPIN LTD
209974 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Discontinued No No AB1 2018/04/17 PAI HOLDINGS PHARM
209095 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 2018/05/10 GLENMARK PHARMS
210034 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 2018/06/15 XIROMED
211074 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 2018/10/15 ZYDUS PHARMS
211256 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 2018/12/26 AMNEAL
211401 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 2019/01/11 RISING
211836 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Discontinued No No AB1 2019/12/30 TORRENT
213291 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No No AB1 2020/01/27 ALEMBIC
212982 001 ANDA CLOBETASOL PROPIONATE CLOBETASOL PROPIONATE CREAM;TOPICAL 0.05% Prescription No Yes AB1 2020/08/28 ENCUBE
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