| 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 AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;10MG | No | No | AA | 2007/11/27 | 2007/11/27 | Prescription |
| 002 | OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | TABLET;ORAL | 325MG;7.5MG | No | No | AA | 2014/06/27 | Prescription |
| 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 |
|---|---|---|---|---|---|---|
| 2007/11/27 | ORIG-1（原始申请） | Approval |
| 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 |
|---|---|---|---|---|---|---|
| 2024/10/31 | SUPPL-32（补充） | Approval | REMS - MODIFIED - D-N-A | |||
| 2024/03/13 | SUPPL-31（补充） | Approval | Labeling-Medication Guide,Labeling-Package Insert | STANDARD | ||
| 2024/01/03 | SUPPL-30（补充） | Approval | Labeling-Medication Guide,Labeling-Package Insert | STANDARD | ||
| 2024/01/03 | SUPPL-29（补充） | Approval | Labeling-Package Insert,Labeling-Medication Guide | STANDARD | ||
| 2024/01/03 | SUPPL-27（补充） | Approval | Labeling-Medication Guide,Labeling-Container/Carton Labels,Labeling-Package Insert | STANDARD | ||
| 2021/03/04 | SUPPL-25（补充） | Approval | Labeling-Medication Guide,Labeling-Package Insert | STANDARD | ||
| 2019/10/07 | SUPPL-19（补充） | Approval | Labeling-Package Insert,Labeling-Medication Guide | STANDARD | ||
| 2018/09/21 | SUPPL-15（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2018/09/18 | SUPPL-16（补充） | Approval | REMS - PROPOSAL - D-N-A | |||
| 2016/12/16 | SUPPL-14（补充） | Approval | Labeling-Package Insert,Labeling-Medication Guide | STANDARD | ||
| 2016/12/16 | SUPPL-13（补充） | Approval | Labeling-Medication Guide,Labeling-Container/Carton Labels,Labeling-Package Insert | STANDARD | ||
| 2016/12/15 | SUPPL-11（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2013/10/18 | SUPPL-9（补充） | Approval | Labeling-Package Insert | STANDARD | ||
| 2011/06/29 | SUPPL-6（补充） | Approval | Labeling-Package Insert |
| 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 | |||||||||
| 关联产品号 | 独占权代码 | 失效日期 | 备注 |
|---|---|---|---|
| 无 | |||
| 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 | RLD | RS | TE 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 | Discontinued | 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 |
| 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 | RLD | RS | TE 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 | Discontinued | 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 |