药品注册申请号：084176
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 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Yes Yes AB 1975/02/18 Approved Prior to Jan 1, 1982 Prescription
002 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 12.5MG No No None 2009/05/22 Discontinued
003 PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Yes No AB Approved Prior to Jan 1, 1982 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
>>>原始批准或临时批准<<<
审批日期提交号审批结论提交分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
1975/02/18 ORIG-1（原始申请） Approval
>>>补充申请<<<
审批日期提交号审批结论补充类别或审批类型审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2009/05/22 SUPPL-62（补充） Approval Labeling
2005/06/09 SUPPL-59（补充） Approval Labeling
2004/12/22 SUPPL-57（补充） Approval Labeling
2002/12/16 SUPPL-54（补充） Approval Manufacturing (CMC)-Control
2002/11/20 SUPPL-52（补充） Approval Manufacturing (CMC)-Packaging
2002/04/19 SUPPL-53（补充） Approval Manufacturing (CMC)-Control
2001/03/23 SUPPL-51（补充） Approval Manufacturing (CMC)-Control
1999/05/05 SUPPL-50（补充） Approval Manufacturing (CMC)
1998/12/15 SUPPL-49（补充） Approval Manufacturing (CMC)
1996/10/03 SUPPL-48（补充） Approval Manufacturing (CMC)
1995/12/01 SUPPL-47（补充） Approval Manufacturing (CMC)
1995/03/17 SUPPL-46（补充） Approval Manufacturing (CMC)
1991/08/28 SUPPL-45（补充） Approval Labeling
1988/11/01 SUPPL-44（补充） Approval Labeling
1986/01/03 SUPPL-43（补充） Approval Manufacturing (CMC)
1985/02/07 SUPPL-41（补充） Approval Manufacturing (CMC)
1983/12/13 SUPPL-40（补充） Approval Manufacturing (CMC)
1983/12/13 SUPPL-39（补充） Approval Manufacturing (CMC)
1983/11/02 SUPPL-38（补充） Approval Manufacturing (CMC)
1983/02/01 SUPPL-37（补充） Approval Manufacturing (CMC)
1982/06/23 SUPPL-36（补充） Approval Manufacturing (CMC)
1982/06/23 SUPPL-27（补充） Approval Manufacturing (CMC)
1982/05/12 SUPPL-30（补充） Approval Manufacturing (CMC)
1982/05/12 SUPPL-28（补充） Approval Manufacturing (CMC)
1982/05/12 SUPPL-17（补充） Approval Manufacturing (CMC)
1982/05/12 SUPPL-16（补充） Approval Manufacturing (CMC)
1982/03/23 SUPPL-35（补充） Approval Manufacturing (CMC)
1981/05/01 SUPPL-31（补充） Approval Manufacturing (CMC)
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
无
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
无
与本品治疗等效的药品
>>>活性成分:PROMETHAZINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:50MG; 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
040713 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB -- KVK TECH
083711 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB Approved Prior to Jan 1, 1982 WATSON LABS
084176 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription Yes Yes AB Approved Prior to Jan 1, 1982 SANDOZ
040596 003 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2005/11/18 ZYDUS PHARMS USA
040622 003 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2006/07/18 PRINSTON INC
040712 003 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2006/07/31 KVK TECH
040673 003 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2008/03/05 QUAGEN
040863 003 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Discontinued No No AB 2008/12/30 SUN PHARM INDS INC
091179 003 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2010/12/13 AMNEAL PHARMS NY
209177 003 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 50MG Prescription No No AB 2017/06/30 STRIDES PHARMA
>>>活性成分:PROMETHAZINE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 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
083426 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB Approved Prior to Jan 1, 1982 WATSON LABS
084176 003 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription Yes No AB Approved Prior to Jan 1, 1982 SANDOZ
040596 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2005/11/18 ZYDUS PHARMS USA
040622 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2006/07/18 PRINSTON INC
040712 001 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2006/07/31 KVK TECH
040673 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2008/03/05 QUAGEN
040863 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Discontinued No No AB 2008/12/30 SUN PHARM INDS INC
091179 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2010/12/13 AMNEAL PHARMS NY
209177 002 ANDA PROMETHAZINE HYDROCHLORIDE PROMETHAZINE HYDROCHLORIDE TABLET;ORAL 25MG Prescription No No AB 2017/06/30 STRIDES PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
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