药品注册申请号:062364
申请类型:ANDA (仿制药申请)
申请人:TARO
申请人全名:TARO 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 NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% No Yes AT 1987/12/22 1987/12/22 Prescription
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
2007/09/04 SUPPL-17(补充) Approval Manufacturing (CMC)
2001/03/19 SUPPL-11(补充) Approval Manufacturing (CMC)
1997/05/27 SUPPL-10(补充) Approval Manufacturing (CMC)
1996/09/17 SUPPL-9(补充) Approval Manufacturing (CMC)
1996/04/30 SUPPL-7(补充) Approval Manufacturing (CMC)
1995/08/24 SUPPL-8(补充) Approval Manufacturing (CMC)
1994/10/19 SUPPL-4(补充) Approval Manufacturing (CMC)
1993/12/03 SUPPL-6(补充) Approval Labeling
1993/03/16 SUPPL-5(补充) Approval Manufacturing (CMC)
1992/10/30 SUPPL-3(补充) Approval Labeling
1989/12/07 SUPPL-2(补充) Approval Manufacturing (CMC)
1988/09/12 SUPPL-1(补充) Approval Manufacturing (CMC)
1987/12/22 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:NYSTATIN; TRIAMCINOLONE ACETONIDE 剂型/给药途径:CREAM;TOPICAL 规格:100,000 UNITS/GM;0.1% 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
062367 001 ANDA MYKACET NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Discontinued No No AT 1985/05/28 COSETTE
062599 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No No AT 1985/10/08 FOUGERA PHARMS INC
062364 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No Yes AT 1987/12/22 TARO
208136 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No No AT 2016/10/24 GLENMARK PHARMS LTD
208326 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No No AT 2016/10/26 DR REDDYS
208479 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No No AT 2017/08/14 PADAGIS ISRAEL
207730 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No No AT 2017/12/26 CROWN LABS INC
209990 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No No AT 2018/02/15 AMNEAL
208205 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No No AT 2018/05/31 LUPIN LTD
213142 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Discontinued No No AT 2020/07/14 TORRENT
214090 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No No AT 2021/03/31 ALEMBIC
214181 001 ANDA NYSTATIN AND TRIAMCINOLONE ACETONIDE NYSTATIN; TRIAMCINOLONE ACETONIDE CREAM;TOPICAL 100,000 UNITS/GM;0.1% Prescription No No AT 2022/07/13 MACLEODS PHARMS LTD
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