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 |
|---|
| 2023/09/22 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2021/03/30 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2020/02/20 |
ORIG-1（原始申请） |
Approval |
|
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:TRIENTINE HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:250MG 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 |
|---|
| 019194 |
001 |
NDA |
SYPRINE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
Yes |
Yes |
AB |
1985/11/08
|
BAUSCH |
| 207567 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2018/02/07
|
WATSON LABS TEVA |
| 211251 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/01/16
|
NAVINTA LLC |
| 211554 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/04/26
|
ZYDUS PHARMS |
| 211134 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/05/22
|
MSN |
| 211076 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/07/03
|
DR REDDYS |
| 210096 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/09/25
|
ENDO OPERATIONS |
| 212238 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2020/02/20
|
RISING |
| 209945 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2021/08/13
|
ECI PHARMS LLC |
| 212929 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Discontinued |
No |
No |
AB |
2021/08/30
|
ACCORD HLTHCARE |
| 216356 |
001 |
ANDA |
TRIENTINE HYDROCHLORIDE |
TRIENTINE HYDROCHLORIDE |
CAPSULE;ORAL |
250MG |
Prescription |
No |
No |
AB |
2022/06/23
|
HETERO LABS LTD III |