药品注册申请号：005213
申请类型：NDA (新药申请)
申请人：GENUS
申请人全名：GENUS LIFESCIENCES 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 HYCODAN HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE TABLET;ORAL 1.5MG;5MG Yes No AA 1943/03/23 1988/07/26 Prescription
002 HYCODAN HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP;ORAL 1.5MG/5ML;5MG/5ML Yes No AA 1988/07/26 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
1943/03/23 ORIG-1（原始申请） Approval Type 1 - New Molecular Entity STANDARD
>>>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
2023/12/15 SUPPL-46（补充） Approval Labeling-Package Insert STANDARD
2021/09/27 SUPPL-44（补充） Approval STANDARD
2018/06/28 SUPPL-39（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2017/01/13 SUPPL-38（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2009/01/26 SUPPL-37（补充） Approval Labeling STANDARD
2002/01/16 SUPPL-30（补充） Approval Manufacturing (CMC)-Control STANDARD
2001/06/15 SUPPL-29（补充） Approval Manufacturing (CMC) STANDARD
2000/07/10 SUPPL-27（补充） Approval Manufacturing (CMC)-Packaging STANDARD
1999/04/23 SUPPL-28（补充） Approval Manufacturing (CMC)-Control STANDARD
1992/04/22 SUPPL-24（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/12/23 SUPPL-22（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/11/08 SUPPL-23（补充） Approval Manufacturing (CMC) STANDARD
1988/07/26 SUPPL-15（补充） Approval Labeling
1988/07/26 SUPPL-14（补充） Approval Manufacturing (CMC)-Control STANDARD
1988/07/26 SUPPL-13（补充） Approval Efficacy-New Indication
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:HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE; 剂型/给药途径:TABLET;ORAL; 规格:1.5MG;5MG; 治疗等效代码:AA<<<
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
005213 001 NDA HYCODAN HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE TABLET;ORAL 1.5MG;5MG Prescription Yes No AA 1988/07/26 GENUS
091528 001 ANDA HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE TABLET;ORAL 1.5MG;5MG Discontinued No No AA 2011/04/20 NOVEL LABS INC
207176 001 ANDA HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE TABLET;ORAL 1.5MG;5MG Prescription No Yes AA 2017/08/07 AVANTHI INC
>>>活性成分:HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE; 剂型/给药途径:SYRUP;ORAL; 规格:1.5MG/5ML;5MG/5ML; 治疗等效代码:AA<<<
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
088008 001 ANDA HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP;ORAL 1.5MG/5ML;5MG/5ML Prescription No No AA 1983/03/03 PHARMOBEDIENT
088017 001 ANDA HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP;ORAL 1.5MG/5ML;5MG/5ML Prescription No No AA 1983/07/05 ACTAVIS MID ATLANTIC
005213 002 NDA HYCODAN HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP;ORAL 1.5MG/5ML;5MG/5ML Prescription Yes No AA 1988/07/26 GENUS
040613 001 ANDA HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP;ORAL 1.5MG/5ML;5MG/5ML Discontinued No No AA 2008/02/08 GENUS LIFESCIENCES
203535 001 ANDA HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP;ORAL 1.5MG/5ML;5MG/5ML Prescription No No AA 2017/02/13 NOVEL LABS INC
205731 001 ANDA HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP;ORAL 1.5MG/5ML;5MG/5ML Prescription No No AA 2017/02/15 PADAGIS US
207487 001 ANDA HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE SYRUP;ORAL 1.5MG/5ML;5MG/5ML Prescription No Yes AA 2017/02/21 ABHAI LLC
更多信息
药品NDC数据与药品包装、标签说明书
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