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 |
|---|
| 1994/01/24 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/06/04 |
SUPPL-4（补充） |
Approval |
Labeling |
|
|
|
| 1989/04/10 |
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:PRAZOSIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 2MG BASE 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 |
|---|
| 071995 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
--
|
TEVA PHARMS |
| 017442 |
003 |
NDA |
MINIPRESS |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 071745 |
003 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
1988/09/12
|
TEVA PHARMS |
| 072575 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
1989/05/16
|
MYLAN |
| 072577 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Discontinued |
No |
No |
AB |
1989/05/16
|
ANI PHARMS |
| 210971 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2018/10/03
|
NOVITIUM PHARMA |
| 214608 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2021/12/23
|
GRANULES |
| 213406 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2022/10/21
|
APPCO |
| 215697 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2022/12/30
|
MANKIND PHARMA |
| 217268 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2023/03/06
|
ALEMBIC |
| 213052 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2023/03/31
|
AUROBINDO PHARMA LTD |
| 214083 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Discontinued |
No |
No |
AB |
2024/01/03
|
LANNETT CO INC |
| 216727 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 2MG BASE |
Prescription |
No |
No |
AB |
2024/09/17
|
MSN |
活性成分:PRAZOSIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 1MG BASE 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 |
|---|
| 071994 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
--
|
IVAX SUB TEVA PHARMS |
| 017442 |
002 |
NDA |
MINIPRESS |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 071745 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
1988/09/12
|
TEVA PHARMS |
| 072575 |
003 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
1989/05/16
|
MYLAN |
| 072577 |
002 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Discontinued |
No |
No |
AB |
1989/05/16
|
ANI PHARMS |
| 210971 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2018/10/03
|
NOVITIUM PHARMA |
| 214608 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2021/12/23
|
GRANULES |
| 213406 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2022/10/21
|
APPCO |
| 215697 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2022/12/30
|
MANKIND PHARMA |
| 217268 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/03/06
|
ALEMBIC |
| 213052 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/03/31
|
AUROBINDO PHARMA LTD |
| 214083 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Discontinued |
No |
No |
AB |
2024/01/03
|
LANNETT CO INC |
| 216727 |
001 |
ANDA |
PRAZOSIN HYDROCHLORIDE |
PRAZOSIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2024/09/17
|
MSN |