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 |
|---|
| 2014/07/17 |
SUPPL-35（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2007/12/12 |
SUPPL-33（补充） |
Approval |
Labeling |
|
|
|
| 2007/06/25 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 2006/01/30 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 2005/09/30 |
SUPPL-26（补充） |
Approval |
Labeling |
|
|
|
| 2005/08/03 |
SUPPL-25（补充） |
Approval |
Labeling |
|
|
|
| 2005/07/07 |
SUPPL-24（补充） |
Approval |
Labeling |
|
|
|
| 2000/10/31 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 1999/02/16 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/06/01 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/06/01 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/11/26 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/11/26 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/11/21 |
SUPPL-15（补充） |
Approval |
Labeling |
|
|
|
| 1994/08/25 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/08/09 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/11/08 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1989/06/28 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 1989/04/03 |
SUPPL-10（补充） |
Approval |
Labeling |
|
|
|
| 1989/03/15 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 1988/05/12 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 1988/04/19 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1988/03/30 |
SUPPL-5（补充） |
Approval |
Labeling |
|
|
|
| 1988/03/30 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/03/30 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/11/09 |
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:DOXEPIN HYDROCHLORIDE 剂型/给药途径:CAPSULE;ORAL 规格:EQ 25MG 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 |
|---|
| 071437 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
--
|
PAR PHARM |
| 070791 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
Yes |
AB |
1986/05/13
|
MYLAN PHARMS INC |
| 071422 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Discontinued |
No |
No |
AB |
1987/11/09
|
ENDO OPERATIONS |
| 207482 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2017/06/28
|
AMNEAL PHARMS CO |
| 211603 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2019/03/27
|
AUROBINDO PHARMA LTD |
| 212624 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2019/09/13
|
AJANTA PHARMA LTD |
| 213063 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2020/07/01
|
TARO |
| 213474 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2020/07/28
|
CONTRACT PHARMACAL |
| 210268 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2020/09/04
|
CHARTWELL RX |
| 210675 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2020/10/16
|
EPIC PHARMA LLC |
| 211619 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/03/09
|
CHEMISTRY HLTH |
| 214908 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/04/01
|
APPCO |
| 215076 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2021/04/21
|
ALEMBIC |
| 215710 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2022/02/09
|
MANKIND PHARMA |
| 215483 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2022/03/14
|
JUBILANT CADISTA |
| 215113 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2022/06/24
|
MSN |
| 210700 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2023/03/23
|
ZYDUS LIFESCIENCES |
| 217688 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2023/06/27
|
MICRO LABS |
| 217975 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 25MG BASE |
Prescription |
No |
No |
AB |
2023/08/21
|
UNIQUE PHARM |