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
>>>原始批准或临时批准<<<
| 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 |
|---|
| 2011/08/29 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
>>>补充申请<<<
| 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 |
|---|
| 2025/10/21 |
SUPPL-17（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2024/10/31 |
SUPPL-18（补充） |
Approval |
REMS - MODIFIED - D-N-A |
|
|
|
| 2023/12/15 |
SUPPL-14（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2021/09/10 |
SUPPL-12（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2021/03/04 |
SUPPL-11（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2019/10/09 |
SUPPL-9（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2018/09/21 |
SUPPL-8（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-7（补充） |
Approval |
REMS - PROPOSAL - D-N-A |
|
|
|
| 2018/08/24 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2017/08/29 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2015/10/15 |
SUPPL-3（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
STANDARD
|
|
|
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, EXTENDED RELEASE;ORAL; 规格:100MG; 治疗等效代码:AB1<<<
| 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 |
|---|
| 200503 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
Yes |
AB1 |
2011/08/29
|
LUPIN LTD |
| 201384 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Discontinued |
No |
No |
AB1 |
2011/12/07
|
SUN PHARM |
| 205257 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Discontinued |
No |
No |
AB1 |
2015/12/22
|
MYLAN |
| 209404 |
001 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
100MG |
Prescription |
No |
No |
AB1 |
2025/01/31
|
MACLEODS PHARMS LTD |
>>>活性成分:TRAMADOL HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:200MG; 治疗等效代码:AB1<<<
| 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 |
|---|
| 200503 |
002 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB1 |
2011/08/29
|
LUPIN LTD |
| 201384 |
002 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Discontinued |
No |
No |
AB1 |
2011/12/07
|
SUN PHARM |
| 205257 |
002 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Discontinued |
No |
No |
AB1 |
2015/12/22
|
MYLAN |
| 209404 |
002 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
200MG |
Prescription |
No |
No |
AB1 |
2025/01/31
|
MACLEODS PHARMS LTD |
>>>活性成分:TRAMADOL HYDROCHLORIDE; 剂型/给药途径:TABLET, EXTENDED RELEASE;ORAL; 规格:300MG; 治疗等效代码:AB1<<<
| 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 |
|---|
| 200503 |
003 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB1 |
2011/08/29
|
LUPIN LTD |
| 201384 |
003 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Discontinued |
No |
No |
AB1 |
2011/12/07
|
SUN PHARM |
| 205257 |
003 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Discontinued |
No |
No |
AB1 |
2015/12/22
|
MYLAN |
| 209404 |
003 |
ANDA |
TRAMADOL HYDROCHLORIDE |
TRAMADOL HYDROCHLORIDE |
TABLET, EXTENDED RELEASE;ORAL |
300MG |
Prescription |
No |
No |
AB1 |
2025/01/31
|
MACLEODS PHARMS LTD |