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
>>>原始批准或临时批准<<<
审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
2023/08/21 |
ORIG-1(原始申请) |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
无 |
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 10MG 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 |
070791 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
1986/05/13
|
MYLAN PHARMS INC |
071422 |
002 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Discontinued |
No |
No |
AB |
1987/11/09
|
ENDO OPERATIONS |
207482 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2017/06/28
|
AMNEAL PHARMS CO |
211603 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2019/03/27
|
AUROBINDO PHARMA LTD |
212624 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2019/09/13
|
AJANTA PHARMA LTD |
213063 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2020/07/01
|
TARO |
213474 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2020/07/28
|
AIPING PHARM INC |
210268 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2020/09/04
|
CHARTWELL RX |
210675 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2020/10/16
|
EPIC PHARMA LLC |
211619 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2021/03/09
|
LEADING |
214908 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2021/04/01
|
APPCO |
215076 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2021/04/21
|
ALEMBIC |
215710 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2022/02/09
|
MANKIND PHARMA |
215483 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2022/03/14
|
JUBILANT CADISTA |
215113 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2022/06/24
|
MSN |
210700 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2023/03/23
|
ZYDUS LIFESCIENCES |
217688 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2023/06/27
|
MICRO LABS |
217975 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 10MG BASE |
Prescription |
No |
No |
AB |
2023/08/21
|
UNIQUE PHARM |
>>>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
|
AIPING PHARM INC |
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
|
LEADING |
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 |
>>>活性成分:DOXEPIN HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 50MG 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 |
070791 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
1986/05/13
|
MYLAN PHARMS INC |
071422 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Discontinued |
No |
No |
AB |
1987/11/09
|
ENDO OPERATIONS |
207482 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2017/06/28
|
AMNEAL PHARMS CO |
211603 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2019/03/27
|
AUROBINDO PHARMA LTD |
212624 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2019/09/13
|
AJANTA PHARMA LTD |
213063 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2020/07/01
|
TARO |
213474 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2020/07/28
|
AIPING PHARM INC |
210268 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2020/09/04
|
CHARTWELL RX |
211619 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2021/03/09
|
LEADING |
214908 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2021/04/01
|
APPCO |
215076 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2021/04/21
|
ALEMBIC |
215710 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2022/02/09
|
MANKIND PHARMA |
210675 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2022/03/03
|
EPIC PHARMA LLC |
215483 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2022/03/14
|
JUBILANT CADISTA |
215113 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2022/06/24
|
MSN |
210700 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2023/03/23
|
ZYDUS LIFESCIENCES |
217688 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2023/06/27
|
MICRO LABS |
217975 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 50MG BASE |
Prescription |
No |
No |
AB |
2023/08/21
|
UNIQUE PHARM |
>>>活性成分:DOXEPIN HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 75MG 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 |
070791 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
1986/05/13
|
MYLAN PHARMS INC |
071422 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Discontinued |
No |
No |
AB |
1987/11/09
|
ENDO OPERATIONS |
207482 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2017/06/28
|
AMNEAL PHARMS CO |
211603 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2019/03/27
|
AUROBINDO PHARMA LTD |
212624 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2019/09/13
|
AJANTA PHARMA LTD |
213063 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2020/07/01
|
TARO |
213474 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2020/07/28
|
AIPING PHARM INC |
210268 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2020/09/04
|
CHARTWELL RX |
211619 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2021/03/09
|
LEADING |
214908 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2021/04/01
|
APPCO |
215076 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2021/04/21
|
ALEMBIC |
215710 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2022/02/09
|
MANKIND PHARMA |
210675 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2022/03/03
|
EPIC PHARMA LLC |
215483 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2022/03/14
|
JUBILANT CADISTA |
215113 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2022/06/24
|
MSN |
210700 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2023/03/23
|
ZYDUS LIFESCIENCES |
217688 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2023/06/27
|
MICRO LABS |
217975 |
004 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2023/08/21
|
UNIQUE PHARM |
>>>活性成分:DOXEPIN HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:EQ 100MG 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 |
070791 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
Yes |
AB |
1986/05/13
|
MYLAN PHARMS INC |
071422 |
001 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Discontinued |
No |
No |
AB |
1987/11/09
|
ENDO OPERATIONS |
207482 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2017/06/28
|
AMNEAL PHARMS CO |
211603 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2019/03/27
|
AUROBINDO PHARMA LTD |
212624 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2019/09/13
|
AJANTA PHARMA LTD |
213063 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2020/07/01
|
TARO |
213474 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2020/07/28
|
AIPING PHARM INC |
210268 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2020/09/04
|
CHARTWELL RX |
210675 |
003 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2020/10/16
|
EPIC PHARMA LLC |
211619 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2021/03/09
|
LEADING |
214908 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2021/04/01
|
APPCO |
215076 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2021/04/21
|
ALEMBIC |
215710 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2022/02/09
|
MANKIND PHARMA |
215483 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2022/03/14
|
JUBILANT CADISTA |
215113 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2022/06/24
|
MSN |
210700 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2023/03/23
|
ZYDUS LIFESCIENCES |
217688 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2023/06/27
|
MICRO LABS |
217975 |
005 |
ANDA |
DOXEPIN HYDROCHLORIDE |
DOXEPIN HYDROCHLORIDE |
CAPSULE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2023/08/21
|
UNIQUE PHARM |