药品注册申请号:019892
申请类型:NDA (新药申请)
申请人:RHODES PHARMS
申请人全名:RHODES PHARMACEUTICALS LP
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 DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 8MG Yes Yes AB 1992/12/07 1992/12/07 Prescription
002 DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 4MG Yes No AB 2007/11/09 Prescription
003 DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 2MG Yes No AB 2007/11/09 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
2023/12/15 SUPPL-41(补充) Approval Labeling STANDARD
2021/03/04 SUPPL-37(补充) Approval Labeling STANDARD
2019/10/07 SUPPL-35(补充) Approval Labeling STANDARD
2018/09/18 SUPPL-34(补充) Approval Labeling STANDARD
2018/09/18 SUPPL-33(补充) Approval REMS N/A
2016/12/16 SUPPL-29(补充) Approval Labeling STANDARD
2015/01/26 SUPPL-25(补充) Approval Manufacturing (CMC) STANDARD
2013/07/05 SUPPL-23(补充) Approval Manufacturing (CMC) STANDARD
2013/01/24 SUPPL-19(补充) Approval Manufacturing (CMC) STANDARD
2012/12/18 SUPPL-21(补充) Approval Manufacturing (CMC) STANDARD
2007/11/09 SUPPL-15(补充) Approval Manufacturing (CMC) N/A
2006/06/12 SUPPL-9(补充) Approval Labeling STANDARD
2003/03/10 SUPPL-2(补充) Approval Labeling STANDARD
2001/08/22 SUPPL-4(补充) Approval Labeling STANDARD
2001/04/12 SUPPL-7(补充) Approval Manufacturing (CMC) STANDARD
2001/04/12 SUPPL-6(补充) Approval Manufacturing (CMC) STANDARD
2000/02/24 SUPPL-3(补充) Approval Manufacturing (CMC) STANDARD
1995/03/31 SUPPL-1(补充) Approval Labeling STANDARD
1992/12/07 ORIG-1(原始申请) Approval Type 3 - New Dosage Form 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
001 6589960 2020/11/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6589960 2020/11/09 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
002 6589960 2020/11/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6589960 2020/11/09 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
003 6589960 2020/11/09 Y PDF格式**本条是由Drugfuture回溯的历史信息**
6589960 2020/11/09 Y Y PDF格式**本条是由Drugfuture回溯的历史信息**
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:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:8MG 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
019892 001 NDA DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 8MG Prescription Yes Yes AB 1992/12/07 RHODES PHARMS
074597 001 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 8MG Discontinued No No AB 1998/07/29 HIKMA
076855 001 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 8MG Prescription No No AB 2004/12/23 SPECGX LLC
205814 003 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 8MG Prescription No No AB 2016/05/13 AUROLIFE PHARMA LLC
210506 003 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 8MG Prescription No No AB 2018/01/17 ASCENT PHARMS INC
活性成分:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:4MG 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
078439 002 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 4MG Prescription No No AB -- LANNETT
076855 003 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 4MG Prescription No No AB 2007/09/19 SPECGX LLC
019892 002 NDA DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 4MG Prescription Yes No AB 2007/11/09 RHODES PHARMS
074597 003 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 4MG Discontinued No No AB 2009/05/29 HIKMA
205814 002 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 4MG Prescription No No AB 2016/05/13 AUROLIFE PHARMA LLC
210506 002 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 4MG Prescription No No AB 2018/01/17 ASCENT PHARMS INC
活性成分:HYDROMORPHONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:2MG 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
078439 001 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 2MG Prescription No No AB -- LANNETT
076855 002 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 2MG Prescription No No AB 2007/09/19 SPECGX LLC
019892 003 NDA DILAUDID HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 2MG Prescription Yes No AB 2007/11/09 RHODES PHARMS
205814 001 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 2MG Prescription No No AB 2016/05/13 AUROLIFE PHARMA LLC
210506 001 ANDA HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE TABLET;ORAL 2MG Prescription No No AB 2018/01/17 ASCENT PHARMS INC
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