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 |
|---|
| 2020/05/19 |
SUPPL-54（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/05/19 |
SUPPL-51（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/06/15 |
SUPPL-46（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/05/12 |
SUPPL-41（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2007/10/29 |
SUPPL-40（补充） |
Approval |
Labeling |
|
|
|
| 2007/06/26 |
SUPPL-39（补充） |
Approval |
Labeling |
|
|
|
| 2005/08/15 |
SUPPL-37（补充） |
Approval |
Labeling |
|
|
|
| 2005/01/05 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 2002/12/26 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 2002/02/20 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/01/04 |
SUPPL-27（补充） |
Approval |
Labeling |
|
|
|
| 2000/05/26 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 2000/05/26 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/12/02 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/12/02 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/02/12 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/02/12 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/02/18 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/10/09 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/05/07 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/12/11 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/08/16 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/04/30 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/05/05 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/04/06 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/04/06 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/04/06 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/03/04 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1991/09/13 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1991/08/22 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/02/02 |
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:TRAZODONE 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 |
|---|
| 071258 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1987/03/25
|
APOTEX |
| 071523 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1987/12/11
|
TEVA PHARMS USA |
| 072192 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1989/02/02
|
OXFORD PHARMS |
| 073137 |
002 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1993/03/24
|
SUN PHARM INDUSTRIES |
| 202180 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2013/11/27
|
TORRENT |
| 206923 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2017/09/08
|
ACCORD HLTHCARE |
| 205253 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2017/10/10
|
ZYDUS PHARMS |
| 204852 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2020/02/05
|
AUROBINDO PHARMA |
| 211116 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2024/05/20
|
CROSSMEDIKA SA |
| 218988 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2024/08/08
|
GRANULES |
| 217740 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2024/08/27
|
GRAVITI PHARMS |