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 |
2024/08/08 |
ORIG-1(原始申请) |
Approval |
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STANDARD
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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 |
活性成分:TRAZODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:100MG 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 |
071196 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
Yes |
AB |
1987/03/25
|
APOTEX INC |
071524 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1987/12/11
|
TEVA PHARMS USA |
072193 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1989/02/02
|
OXFORD PHARMS |
073137 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
1993/03/24
|
SUN PHARM INDUSTRIES |
202180 |
002 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2013/11/27
|
TORRENT |
206923 |
002 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2017/09/08
|
ACCORD HLTHCARE |
205253 |
002 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2017/10/10
|
ZYDUS PHARMS |
204852 |
002 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2020/02/05
|
AUROBINDO PHARMA |
211116 |
002 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2024/05/20
|
CROSSMEDIKA SA |
218988 |
002 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2024/08/08
|
GRANULES |
217740 |
002 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
100MG |
Prescription |
No |
No |
AB |
2024/08/27
|
GRAVITI PHARMS |
活性成分:TRAZODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:150MG 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 |
071525 |
001 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
1988/03/09
|
PLIVA |
073137 |
003 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
1995/12/22
|
SUN PHARM INDUSTRIES |
071196 |
002 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
1999/04/26
|
APOTEX INC |
202180 |
003 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2013/11/27
|
TORRENT |
206923 |
003 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2017/09/08
|
ACCORD HLTHCARE |
205253 |
003 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2017/10/10
|
ZYDUS PHARMS |
204852 |
003 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2020/02/05
|
AUROBINDO PHARMA |
211116 |
003 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2024/05/20
|
CROSSMEDIKA SA |
218988 |
003 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2024/08/08
|
GRANULES |
217740 |
003 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
150MG |
Prescription |
No |
No |
AB |
2024/08/27
|
GRAVITI PHARMS |
活性成分:TRAZODONE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:300MG 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 |
071196 |
003 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
1999/04/26
|
APOTEX INC |
202180 |
004 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2013/11/27
|
TORRENT |
206923 |
004 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2017/09/08
|
ACCORD HLTHCARE |
205253 |
004 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2017/10/10
|
ZYDUS PHARMS |
204852 |
004 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2020/02/05
|
AUROBINDO PHARMA |
211116 |
004 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/05/20
|
CROSSMEDIKA SA |
218988 |
004 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/08/08
|
GRANULES |
217740 |
004 |
ANDA |
TRAZODONE HYDROCHLORIDE |
TRAZODONE HYDROCHLORIDE |
TABLET;ORAL |
300MG |
Prescription |
No |
No |
AB |
2024/08/27
|
GRAVITI PHARMS |