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 |
|---|
| 2024/03/18 |
SUPPL-19（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/12/15 |
SUPPL-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/12/15 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/04 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/11 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/21 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-12（补充） |
Approval |
REMS |
|
|
|
| 2018/08/24 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/12/15 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/10/18 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/06/27 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2007/01/10 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2006/01/19 |
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 |
与本品治疗等效的药品
活性成分:ACETAMINOPHEN; HYDROCODONE BITARTRATE 剂型/给药途径:TABLET;ORAL 规格:300MG;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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 040658 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
Prescription |
No |
Yes |
AA |
2006/01/19
|
CHARTWELL |
| 202214 |
004 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
Prescription |
No |
No |
AA |
2016/03/15
|
TRIS PHARMA INC |
| 206718 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
Prescription |
No |
No |
AA |
2017/03/31
|
SPECGX LLC |
| 209036 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
Prescription |
No |
No |
AA |
2017/06/21
|
ABHAI LLC |
| 206869 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
Prescription |
No |
No |
AA |
2017/06/23
|
AMNEAL PHARMS NY |
| 207808 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
Prescription |
No |
No |
AA |
2018/03/30
|
RHODES PHARMS |
| 207709 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
Prescription |
No |
No |
AA |
2018/09/13
|
AUROLIFE PHARMA LLC |
| 207509 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;5MG |
Prescription |
No |
No |
AA |
2018/10/29
|
WES PHARMA INC |
活性成分:ACETAMINOPHEN; HYDROCODONE BITARTRATE 剂型/给药途径:TABLET;ORAL 规格:300MG;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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 040658 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
Prescription |
No |
Yes |
AA |
2006/03/24
|
CHARTWELL |
| 202214 |
005 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
Prescription |
No |
No |
AA |
2016/03/15
|
TRIS PHARMA INC |
| 206718 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
Prescription |
No |
No |
AA |
2017/03/31
|
SPECGX LLC |
| 209036 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
Prescription |
No |
No |
AA |
2017/06/21
|
ABHAI LLC |
| 207808 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
Prescription |
No |
No |
AA |
2018/03/30
|
RHODES PHARMS |
| 207709 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
Prescription |
No |
No |
AA |
2018/09/13
|
AUROLIFE PHARMA LLC |
| 207509 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;7.5MG |
Prescription |
No |
No |
AA |
2018/10/29
|
WES PHARMA INC |
活性成分:ACETAMINOPHEN; HYDROCODONE BITARTRATE 剂型/给药途径:TABLET;ORAL 规格:300MG;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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 040658 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
Prescription |
No |
Yes |
AA |
2004/06/23
|
CHARTWELL |
| 202214 |
006 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
Prescription |
No |
No |
AA |
2016/03/15
|
TRIS PHARMA INC |
| 207137 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
Prescription |
No |
No |
AA |
2016/11/29
|
AMNEAL PHARMS |
| 206718 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
Prescription |
No |
No |
AA |
2017/03/31
|
SPECGX LLC |
| 209036 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
Prescription |
No |
No |
AA |
2017/06/21
|
ABHAI LLC |
| 207808 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
Prescription |
No |
No |
AA |
2018/03/30
|
RHODES PHARMS |
| 207709 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
Prescription |
No |
No |
AA |
2018/09/13
|
AUROLIFE PHARMA LLC |
| 207509 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
300MG;10MG |
Prescription |
No |
No |
AA |
2018/10/29
|
WES PHARMA INC |
