药品注册申请号:077723
申请类型:ANDA (仿制药申请)
申请人:NOSTRUM LABS INC
申请人全名:NOSTRUM LABORATORIES 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 HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL 7.5MG;200MG No No AB 2006/11/06 2006/11/06 Prescription
002 HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL 10MG;200MG No No None 2006/11/06 Prescription
003 HYDROCODONE HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL 5MG;200MG No No AB 2006/11/06 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-33(补充) Approval Labeling STANDARD
2023/12/15 SUPPL-32(补充) Approval Labeling STANDARD
2021/09/02 SUPPL-31(补充) Approval Labeling STANDARD
2021/04/30 SUPPL-30(补充) Approval Labeling STANDARD
2021/03/04 SUPPL-29(补充) Approval Labeling STANDARD
2019/10/11 SUPPL-27(补充) Approval Labeling STANDARD
2019/07/22 SUPPL-26(补充) Approval Labeling STANDARD
2018/09/21 SUPPL-23(补充) Approval Labeling STANDARD
2018/09/18 SUPPL-21(补充) Approval REMS STANDARD
2018/09/14 SUPPL-19(补充) Approval Labeling STANDARD
2015/04/03 SUPPL-16(补充) Approval Labeling STANDARD
2015/04/03 SUPPL-4(补充) Approval Labeling
2013/04/23 SUPPL-9(补充) Approval Labeling
2007/12/31 SUPPL-1(补充) Approval Labeling
2007/04/03 SUPPL-2(补充) Approval Labeling
2006/11/06 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:HYDROCODONE BITARTRATE; IBUPROFEN 剂型/给药途径:TABLET;ORAL 规格:7.5MG;200MG 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
076604 001 ANDA HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL 7.5MG;200MG Prescription No No AB 2003/12/31 ACTAVIS LABS FL INC
076642 001 ANDA HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL 7.5MG;200MG Prescription No Yes AB 2004/10/12 AMNEAL PHARMS NY
077723 001 ANDA HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL 7.5MG;200MG Prescription No No AB 2006/11/06 NOSTRUM LABS INC
204575 001 ANDA HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL 7.5MG;200MG Prescription No No AB 2016/06/02 AUROLIFE PHARMA LLC
活性成分:HYDROCODONE BITARTRATE; IBUPROFEN 剂型/给药途径:TABLET;ORAL 规格:5MG;200MG 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
076642 002 ANDA HYDROCODONE BITARTRATE AND IBUPROFEN HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL 5MG;200MG Prescription No No AB 2004/03/18 AMNEAL PHARMS NY
077723 003 ANDA HYDROCODONE HYDROCODONE BITARTRATE; IBUPROFEN TABLET;ORAL 5MG;200MG Prescription No No AB 2006/11/06 NOSTRUM LABS INC
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药品NDC数据与药品包装、标签说明书
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