药品注册申请号：040330
申请类型：ANDA (仿制药申请)
申请人：ENDO OPERATIONS
申请人全名：ENDO OPERATIONS LTD
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 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG No Yes AA 1999/06/25 1999/06/25 Prescription
002 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG No Yes AA 1999/06/25 Prescription
003 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG No Yes AA 2001/11/23 Prescription
004 PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG No Yes AA 2001/11/23 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
2024/10/31 SUPPL-62（补充） Approval REMS
2024/04/03 SUPPL-61（补充） Approval Labeling STANDARD
2023/12/18 SUPPL-59（补充） Approval Labeling STANDARD
2023/12/18 SUPPL-58（补充） Approval Labeling STANDARD
2021/03/04 SUPPL-57（补充） Approval Labeling STANDARD
2019/10/07 SUPPL-55（补充） Approval Labeling STANDARD
2018/09/21 SUPPL-52（补充） Approval Labeling STANDARD
2018/09/18 SUPPL-50（补充） Approval REMS STANDARD
2016/12/16 SUPPL-45（补充） Approval Labeling STANDARD
2016/12/16 SUPPL-44（补充） Approval Labeling STANDARD
2016/12/16 SUPPL-43（补充） Approval Labeling STANDARD
2013/10/18 SUPPL-35（补充） Approval Labeling STANDARD
2012/04/10 SUPPL-31（补充） Approval Labeling
2011/06/28 SUPPL-26（补充） Approval Labeling
2006/11/30 SUPPL-15（补充） Approval Labeling
2004/03/16 SUPPL-14（补充） Approval Labeling
2002/07/31 SUPPL-7（补充） Approval Manufacturing (CMC)
2001/10/18 SUPPL-6（补充） Approval Manufacturing (CMC)
2000/04/12 SUPPL-5（补充） Approval Manufacturing (CMC)
2000/04/12 SUPPL-4（补充） Approval Manufacturing (CMC)
2000/04/12 SUPPL-3（补充） Approval Manufacturing (CMC)
2000/04/12 SUPPL-1（补充） Approval Manufacturing (CMC)
1999/11/02 SUPPL-2（补充） Approval Labeling
1999/06/25 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
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:ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:325MG;2.5MG 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
040330 001 ANDA PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Prescription No Yes AA 1999/06/25 ENDO OPERATIONS
090177 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Discontinued No No AA 2008/10/20 DR REDDYS LABS SA
201447 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Prescription No No AA 2013/04/12 ACTAVIS ELIZABETH
201972 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Prescription No No AA 2013/07/15 AUROLIFE PHARMA LLC
090535 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Discontinued No No AA 2013/12/26 SUN PHARM INDS INC
204407 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Prescription No No AA 2017/02/24 NOVEL LABS INC
207419 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Prescription No No AA 2017/03/22 ASCENT PHARMS INC
210079 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Discontinued No No AA 2017/12/28 NESHER PHARMS
210644 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Prescription No No AA 2018/02/09 ABHAI LLC
211708 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;2.5MG Prescription No No AA 2019/10/31 GRANULES
活性成分:ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:325MG;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
087463 001 ANDA OXYCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 1983/12/07 SPECGX LLC
040330 002 ANDA PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No Yes AA 1999/06/25 ENDO OPERATIONS
040777 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2007/11/27 AMNEAL PHARMS
090177 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Discontinued No No AA 2008/10/20 DR REDDYS LABS SA
201447 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2013/04/12 ACTAVIS ELIZABETH
201972 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2013/07/15 AUROLIFE PHARMA LLC
090535 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Discontinued No No AA 2013/12/26 SUN PHARM INDS INC
201278 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2014/08/28 RHODES PHARMS
202677 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2016/03/08 ALVOGEN
204407 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2017/02/24 NOVEL LABS INC
207419 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2017/03/22 ASCENT PHARMS INC
210079 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Discontinued No No AA 2017/12/28 NESHER PHARMS
210644 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2018/02/09 ABHAI LLC
207510 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2018/03/21 WES PHARMA INC
203864 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2018/07/02 EPIC PHARMA LLC
209385 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2018/07/02 ELITE LABS INC
207834 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2019/08/15 CHARTWELL
211708 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;5MG Prescription No No AA 2019/10/31 GRANULES
活性成分:ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:325MG;7.5MG 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
040330 003 ANDA PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No Yes AA 2001/11/23 ENDO OPERATIONS
040545 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2004/06/30 SPECGX LLC
090177 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Discontinued No No AA 2008/10/20 DR REDDYS LABS SA
202677 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2012/07/26 ALVOGEN
201447 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2013/04/12 ACTAVIS ELIZABETH
201972 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2013/07/15 AUROLIFE PHARMA LLC
090535 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Discontinued No No AA 2013/12/26 SUN PHARM INDS INC
040778 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2014/06/27 AMNEAL PHARMS NY
201278 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2014/08/28 RHODES PHARMS
204407 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2017/02/24 NOVEL LABS INC
207419 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2017/03/22 ASCENT PHARMS INC
210079 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Discontinued No No AA 2017/12/28 NESHER PHARMS
210644 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2018/02/09 ABHAI LLC
207510 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2018/03/21 WES PHARMA INC
209385 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2018/07/02 ELITE LABS INC
203864 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2018/07/02 EPIC PHARMA LLC
207834 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2019/08/15 CHARTWELL
211708 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;7.5MG Prescription No No AA 2019/10/31 GRANULES
活性成分:ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:325MG;10MG 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
040330 004 ANDA PERCOCET ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No Yes AA 2001/11/23 ENDO OPERATIONS
040545 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2004/06/30 SPECGX LLC
040778 001 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2007/11/27 AMNEAL PHARMS NY
090177 004 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Discontinued No No AA 2008/10/20 DR REDDYS LABS SA
202677 002 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2012/07/26 ALVOGEN
201447 004 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2013/04/12 ACTAVIS ELIZABETH
201972 004 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2013/07/15 AUROLIFE PHARMA LLC
090535 004 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Discontinued No No AA 2013/12/26 SUN PHARM INDS INC
201278 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2014/08/28 RHODES PHARMS
204407 004 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2017/02/24 NOVEL LABS INC
207419 004 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2017/03/22 ASCENT PHARMS INC
210079 004 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Discontinued No No AA 2017/12/28 NESHER PHARMS
210644 004 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2018/02/09 ABHAI LLC
207510 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2018/03/21 WES PHARMA INC
209385 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2018/07/02 ELITE LABS INC
203864 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2018/07/02 EPIC PHARMA LLC
207834 003 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2019/08/15 CHARTWELL
211708 004 ANDA OXYCODONE AND ACETAMINOPHEN ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET;ORAL 325MG;10MG Prescription No No AA 2019/10/31 GRANULES
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