药品注册申请号：204021
申请类型：ANDA (仿制药申请)
申请人：NOVEL LABS INC
申请人全名：NOVEL 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 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG No No AB 2017/06/12 2017/06/12 Discontinued
002 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG No No AB 2017/06/12 Discontinued
003 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG No No AB 2017/06/12 Discontinued
004 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG No No AB 2017/06/12 Discontinued
005 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG No No AB 2017/06/12 Discontinued
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
2017/06/12 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
2025/06/18 SUPPL-12（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2025/06/18 SUPPL-11（补充） Approval Labeling-Package Insert STANDARD
2025/06/18 SUPPL-9（补充） Approval Labeling-Package Insert STANDARD
2025/06/18 SUPPL-8（补充） Approval Labeling-Medication Guide,Labeling-Package Insert STANDARD
2025/06/18 SUPPL-5（补充） Approval Labeling-Package Insert,Labeling-Medication Guide STANDARD
2025/06/18 SUPPL-3（补充） Approval Labeling-Package Insert STANDARD
2024/10/31 SUPPL-10（补充） Approval REMS - MODIFIED - D-N-A
2018/09/18 SUPPL-2（补充） Approval REMS - PROPOSAL - D-N-A
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:OXYCODONE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格: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
207418 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB -- ASCENT PHARMS INC
076758 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2007/03/19 SPECGX LLC
077712 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2009/03/02 STRIDES PHARMA INTL
090659 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2009/04/10 SUN PHARM INDS INC
021011 003 NDA ROXICODONE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription Yes No AB 2009/05/15 SPECGX LLC
090895 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2009/08/24 EPIC PHARMA LLC
091393 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2009/08/31 AVANTHI INC
091490 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/03/09 RHODES PHARMS
202116 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2011/12/30 ALVOGEN
202160 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2012/11/19 AUROLIFE PHARMA LLC
203638 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2014/06/03 AMNEAL PHARMS
202662 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2015/09/22 EPIC PHARMA LLC
207119 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Prescription No No AB 2016/04/12 NUVO PHARM
204021 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 5MG Discontinued No No AB 2017/06/12 NOVEL LABS INC
>>>活性成分:OXYCODONE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:10MG; 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
207418 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB -- ASCENT PHARMS INC
091393 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No Yes AB 2009/08/31 AVANTHI INC
091490 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2011/03/09 RHODES PHARMS
090659 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2012/11/06 SUN PHARM INDS INC
203638 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2014/06/03 AMNEAL PHARMS
077712 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/04/13 STRIDES PHARMA INTL
202662 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2015/09/22 EPIC PHARMA LLC
207119 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2016/04/12 NUVO PHARM
204021 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Discontinued No No AB 2017/06/12 NOVEL LABS INC
076758 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 10MG Prescription No No AB 2021/10/12 SPECGX LLC
>>>活性成分:OXYCODONE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:15MG; 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
021011 001 NDA ROXICODONE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription Yes Yes AB 2000/08/31 SPECGX LLC
076758 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2004/06/30 SPECGX LLC
077712 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2007/01/31 STRIDES PHARMA INTL
090659 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Discontinued No No AB 2009/04/10 SUN PHARM INDS INC
090895 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2009/08/24 EPIC PHARMA LLC
091393 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2009/08/31 AVANTHI INC
091490 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2011/03/09 RHODES PHARMS
202116 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2011/12/30 ALVOGEN
202160 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2012/11/19 AUROLIFE PHARMA LLC
203638 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2014/06/03 AMNEAL PHARMS
202662 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2015/09/22 EPIC PHARMA LLC
207119 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2016/04/12 NUVO PHARM
204021 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Discontinued No No AB 2017/06/12 NOVEL LABS INC
207418 001 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 15MG Prescription No No AB 2017/08/07 ASCENT PHARMS INC
>>>活性成分:OXYCODONE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:20MG; 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
207418 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB -- ASCENT PHARMS INC
091393 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2009/08/31 AVANTHI INC
091490 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2011/03/09 RHODES PHARMS
090659 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Discontinued No No AB 2012/11/06 SUN PHARM INDS INC
203638 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2014/06/03 AMNEAL PHARMS
077712 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2015/04/13 STRIDES PHARMA INTL
207119 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2016/04/12 NUVO PHARM
202662 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2017/04/27 EPIC PHARMA LLC
204021 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Discontinued No No AB 2017/06/12 NOVEL LABS INC
076758 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 20MG Prescription No No AB 2021/10/12 SPECGX LLC
>>>活性成分:OXYCODONE HYDROCHLORIDE; 剂型/给药途径:TABLET;ORAL; 规格:30MG; 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
021011 002 NDA ROXICODONE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription Yes No AB 2000/08/31 SPECGX LLC
076758 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2004/06/30 SPECGX LLC
077712 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2007/01/31 STRIDES PHARMA INTL
090659 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Discontinued No No AB 2009/04/10 SUN PHARM INDS INC
090895 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2009/08/24 EPIC PHARMA LLC
091393 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2009/08/31 AVANTHI INC
091490 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2011/03/09 RHODES PHARMS
202116 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2011/12/30 ALVOGEN
202160 003 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2012/11/19 AUROLIFE PHARMA LLC
203638 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2014/06/03 AMNEAL PHARMS
202662 004 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2015/09/22 EPIC PHARMA LLC
207119 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2016/04/12 NUVO PHARM
204021 005 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Discontinued No No AB 2017/06/12 NOVEL LABS INC
207418 002 ANDA OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE TABLET;ORAL 30MG Prescription No No AB 2017/08/07 ASCENT PHARMS INC
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药品NDC数据与药品包装、标签说明书
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