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 |
|---|
| 2024/01/05 |
SUPPL-56（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/11/18 |
SUPPL-55（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/02/07 |
SUPPL-50（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2022/09/21 |
SUPPL-49（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/21 |
SUPPL-48（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/21 |
SUPPL-43（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/21 |
SUPPL-40（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/21 |
SUPPL-39（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/21 |
SUPPL-38（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/21 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2022/09/21 |
SUPPL-33（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-37（补充） |
Approval |
REMS |
|
|
|
| 2015/04/16 |
SUPPL-30（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/04/16 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 2013/09/27 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2011/09/30 |
SUPPL-22（补充） |
Approval |
Labeling |
|
|
|
| 2004/07/26 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 2002/10/29 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 2002/07/18 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2002/06/20 |
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:TRAMADOL HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 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 |
|---|
| 075964 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
Yes |
AB |
2002/06/19
|
SUN PHARM INDS INC |
| 075977 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2002/06/19
|
TEVA |
| 076003 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2002/06/20
|
AMNEAL PHARMS |
| 075986 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Discontinued |
No |
No |
AB |
2002/06/21
|
MYLAN |
| 075981 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2002/07/10
|
APOTEX |
| 090404 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2011/01/31
|
ZYDUS PHARMS USA INC |
| 202075 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2011/11/28
|
ACI |
| 201973 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2012/11/16
|
IPCA LABS LTD |
| 091498 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2013/03/29
|
CSPC OUYI PHARM CO |
| 203494 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2014/03/31
|
AUROBINDO PHARMA LTD |
| 208708 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2019/06/28
|
RUBICON |
| 206706 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2019/07/02
|
MERRO PHARM USA |
| 211825 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2019/08/09
|
UNICHEM |
