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-8（补充） |
Approval |
REMS |
|
|
|
| 2023/12/15 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/12/13 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/14 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/14 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-3（补充） |
Approval |
REMS |
|
|
|
| 2012/03/30 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
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; TRAMADOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:325MG;37.5MG 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 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 021123 |
001 |
NDA |
ULTRACET |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
325MG;37.5MG |
Discontinued |
Yes |
No |
AB |
2001/08/15
|
JANSSEN PHARMS |
| 077184 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
325MG;37.5MG |
Discontinued |
No |
No |
AB |
2005/12/16
|
SUN PHARM INDS INC |
| 077858 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
325MG;37.5MG |
Prescription |
No |
No |
AB |
2008/09/26
|
RISING |
| 090485 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
325MG;37.5MG |
Prescription |
No |
Yes |
AB |
2009/12/09
|
AMNEAL PHARMS |
| 202076 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
325MG;37.5MG |
Prescription |
No |
No |
AB |
2012/03/30
|
ALKEM LABS LTD |
| 090460 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
325MG;37.5MG |
Prescription |
No |
No |
AB |
2012/09/06
|
ZYDUS PHARMS USA INC |
| 201952 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
325MG;37.5MG |
Prescription |
No |
No |
AB |
2012/12/14
|
MICRO LABS LTD INDIA |
| 207152 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
325MG;37.5MG |
Prescription |
No |
No |
AB |
2017/03/22
|
AUROBINDO PHARMA |