药品注册申请号:040428
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 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG No Yes AB 2002/02/05 2002/02/05 Prescription
002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG No No AB 2003/03/31 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
2016/09/02 SUPPL-31(补充) Approval Labeling STANDARD
2012/12/18 SUPPL-26(补充) Approval Labeling
2012/12/18 SUPPL-25(补充) Approval Labeling
2010/05/26 SUPPL-24(补充) Approval Labeling
2010/04/26 SUPPL-23(补充) Approval Labeling
2005/10/13 SUPPL-19(补充) Approval Labeling
2004/10/06 SUPPL-8(补充) Approval Labeling
2004/06/18 SUPPL-5(补充) Approval Labeling
2003/03/31 SUPPL-4(补充) Approval Labeling
2003/03/31 SUPPL-2(补充) Approval Manufacturing (CMC)
2002/11/20 SUPPL-1(补充) Approval Labeling
2002/02/05 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:PROMETHAZINE HYDROCHLORIDE 剂型/给药途径:SUPPOSITORY;RECTAL 规格:25MG 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
040428 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG Prescription No Yes AB 2002/02/05 COSETTE
040500 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG Prescription No No AB 2003/06/30 PADAGIS ISRAEL
040603 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG Prescription No No AB 2006/10/26 TARO
216446 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 25MG Prescription No No AB 2022/11/02 ANNORA PHARMA
活性成分:PROMETHAZINE HYDROCHLORIDE 剂型/给药途径:SUPPOSITORY;RECTAL 规格:12.5MG 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
040428 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG Prescription No No AB 2003/03/31 COSETTE
040500 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG Prescription No No AB 2003/06/30 PADAGIS ISRAEL
040603 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG Prescription No No AB 2006/10/26 TARO
216446 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE SUPPOSITORY;RECTAL 12.5MG Prescription No No AB 2022/11/02 ANNORA PHARMA
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