药品注册申请号:205935
申请类型:ANDA (仿制药申请)
申请人:SANDOZ
申请人全名:SANDOZ 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 FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) No No AO 2019/05/14 2019/05/14 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
2021/03/19 SUPPL-6(补充) Approval Labeling STANDARD
2021/03/19 SUPPL-5(补充) Approval Labeling STANDARD
2021/03/19 SUPPL-4(补充) Approval Labeling STANDARD
2021/03/19 SUPPL-2(补充) Approval Labeling STANDARD
2019/05/14 ORIG-1(原始申请) Approval 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:FULVESTRANT 剂型/给药途径:SOLUTION;INTRAMUSCULAR 规格:250MG/5ML (50MG/ML) 治疗等效代码:AO
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
021344 001 NDA FASLODEX FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription Yes Yes AO 2002/04/25 ASTRAZENECA
210044 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2019/03/04 AMNEAL
205935 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2019/05/14 SANDOZ
210326 001 NDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2019/05/20 FRESENIUS KABI USA
208811 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2019/07/23 EUGIA PHARMA
207754 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2019/08/22 GLENMARK PHARMS INC
205871 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2019/08/22 SAGENT PHARMS INC
209714 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2019/11/21 HBT LABS INC
211422 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2020/02/07 CHIA TAI TIANQING
209246 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2020/08/07 DR REDDYS
211689 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2020/11/17 ACCORD HLTHCARE
215234 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2021/07/29 ZYDUS PHARMS
213553 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2021/08/13 XIROMED
214682 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2022/02/10 JIANGSU HANSOH PHARM
215077 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2022/12/22 ALEMBIC
215169 001 ANDA FULVESTRANT FULVESTRANT SOLUTION;INTRAMUSCULAR 250MG/5ML (50MG/ML) Prescription No No AO 2023/06/30 EUGIA PHARMA
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