| 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 ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | No | No | AA | 2006/08/25 | 2006/08/25 | Prescription |
| 002 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | No | No | AA | 2016/05/10 | Prescription |
| 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-37（补充） | Approval | REMS | |||
| 2024/02/06 | SUPPL-36（补充） | Approval | Labeling | STANDARD | ||
| 2024/02/05 | SUPPL-35（补充） | Approval | Labeling | STANDARD | ||
| 2024/02/05 | SUPPL-34（补充） | Approval | Labeling | STANDARD | ||
| 2024/02/01 | SUPPL-31（补充） | Approval | Labeling | STANDARD | ||
| 2021/03/04 | SUPPL-29（补充） | Approval | Labeling | STANDARD | ||
| 2019/10/10 | SUPPL-23（补充） | Approval | Labeling | STANDARD | ||
| 2018/09/21 | SUPPL-21（补充） | Approval | Labeling | STANDARD | ||
| 2018/09/18 | SUPPL-20（补充） | Approval | REMS | |||
| 2016/12/16 | SUPPL-18（补充） | Approval | Labeling | STANDARD | ||
| 2016/12/16 | SUPPL-17（补充） | Approval | Labeling | STANDARD | ||
| 2016/05/10 | SUPPL-12（补充） | Approval | Manufacturing (CMC) | |||
| 2015/07/02 | SUPPL-15（补充） | Approval | Labeling | STANDARD | ||
| 2014/06/23 | SUPPL-13（补充） | Approval | Labeling | STANDARD | ||
| 2013/04/26 | SUPPL-8（补充） | Approval | Manufacturing (CMC) | |||
| 2011/06/24 | SUPPL-10（补充） | Approval | Labeling | |||
| 2008/03/20 | SUPPL-1（补充） | Approval | Manufacturing (CMC) | |||
| 2006/08/25 | ORIG-1（原始申请） | Approval |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 040355 | 001 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2000/05/31 | STRIDES PHARMA |
| 040400 | 001 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | Yes | AA | 2000/07/26 | SPECGX LLC |
| 040746 | 001 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2006/08/25 | AMNEAL PHARMS NY |
| 090118 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Discontinued | No | No | AA | 2008/12/23 | SUN PHARM INDS INC |
| 201013 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2012/04/11 | AUROLIFE PHARMA LLC |
| 202214 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2013/03/27 | TRIS PHARMA INC |
| 202991 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2016/04/12 | RHODES PHARMS |
| 202935 | 004 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2016/06/15 | STRIDES PHARMA |
| 209037 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2017/06/21 | ABHAI LLC |
| 210211 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2017/10/30 | WES PHARMA INC |
| 203863 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2018/03/30 | EPIC PHARMA LLC |
| 211487 | 004 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2018/11/07 | ASCENT PHARMS INC |
| 209924 | 004 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2018/11/16 | ELITE LABS INC |
| 211729 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Prescription | No | No | AA | 2020/01/03 | GRANULES |
| 214928 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;10MG | Discontinued | No | No | AA | 2021/12/30 | PRINSTON INC |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 040405 | 001 | ANDA | ANEXSIA 7.5/325 | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | Yes | AA | 2000/09/08 | SPECGX LLC |
| 040432 | 001 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2003/01/22 | CHARTWELL |
| 040656 | 001 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2006/01/19 | STRIDES PHARMA |
| 090118 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Discontinued | No | No | AA | 2008/12/23 | SUN PHARM INDS INC |
| 201013 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2012/04/11 | AUROLIFE PHARMA LLC |
| 202214 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2013/03/27 | TRIS PHARMA INC |
| 202991 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2016/04/12 | RHODES PHARMS |
| 040746 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2016/05/10 | AMNEAL PHARMS NY |
| 202935 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2016/06/15 | STRIDES PHARMA |
| 209037 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2017/06/21 | ABHAI LLC |
| 210211 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2017/10/30 | WES PHARMA INC |
| 203863 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2018/03/30 | EPIC PHARMA LLC |
| 211487 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2018/11/07 | ASCENT PHARMS INC |
| 209924 | 003 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2018/11/16 | ELITE LABS INC |
| 211729 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Prescription | No | No | AA | 2020/01/03 | GRANULES |
| 214928 | 002 | ANDA | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | ACETAMINOPHEN; HYDROCODONE BITARTRATE | TABLET;ORAL | 325MG;7.5MG | Discontinued | No | No | AA | 2021/12/30 | PRINSTON INC |