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 |
|---|
| 2022/01/03 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
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:DOXYCYCLINE HYCLATE 剂型/给药途径:TABLET, DELAYED RELEASE;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 |
|---|
| 050795 |
001 |
NDA |
DORYX |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 75MG BASE |
Discontinued |
Yes |
No |
AB |
2005/05/06
|
MAYNE PHARMA |
| 090134 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2011/12/14
|
ACTAVIS ELIZABETH |
| 200856 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2013/04/30
|
HERITAGE PHARMS |
| 213075 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 75MG BASE |
Prescription |
No |
No |
AB |
2022/01/03
|
ALEMBIC |
| 208741 |
003 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 75MG BASE |
Discontinued |
No |
No |
AB |
2023/08/11
|
LUPIN |
活性成分:DOXYCYCLINE HYCLATE 剂型/给药途径:TABLET, DELAYED RELEASE;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 |
|---|
| 050795 |
002 |
NDA |
DORYX |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 100MG BASE |
Discontinued |
Yes |
No |
AB |
2005/05/06
|
MAYNE PHARMA |
| 090134 |
002 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2011/12/14
|
ACTAVIS ELIZABETH |
| 200856 |
002 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2013/04/30
|
HERITAGE PHARMS |
| 213075 |
002 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 100MG BASE |
Prescription |
No |
No |
AB |
2022/01/03
|
ALEMBIC |
| 208741 |
005 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 100MG BASE |
Discontinued |
No |
No |
AB |
2023/08/11
|
LUPIN |
活性成分:DOXYCYCLINE HYCLATE 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:EQ 150MG 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 |
|---|
| 050795 |
003 |
NDA |
DORYX |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 150MG BASE |
Discontinued |
Yes |
No |
AB |
2008/06/20
|
MAYNE PHARMA |
| 200856 |
003 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2013/04/30
|
HERITAGE PHARMS |
| 207494 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2016/11/15
|
PRINSTON INC |
| 213075 |
003 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 150MG BASE |
Prescription |
No |
No |
AB |
2022/01/03
|
ALEMBIC |
| 208741 |
007 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 150MG BASE |
Discontinued |
No |
No |
AB |
2023/08/11
|
LUPIN |
活性成分:DOXYCYCLINE HYCLATE 剂型/给药途径:TABLET, DELAYED RELEASE;ORAL 规格:EQ 200MG 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 |
|---|
| 050795 |
005 |
NDA |
DORYX |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 200MG BASE |
Prescription |
Yes |
No |
AB |
2013/04/11
|
MAYNE PHARMA |
| 207494 |
002 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 200MG BASE |
Prescription |
No |
No |
AB |
2016/11/15
|
PRINSTON INC |
| 090134 |
004 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 200MG BASE |
Prescription |
No |
No |
AB |
2018/05/22
|
ACTAVIS ELIZABETH |
| 200856 |
004 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 200MG BASE |
Prescription |
No |
Yes |
AB |
2018/11/13
|
HERITAGE PHARMS |
| 213075 |
004 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 200MG BASE |
Prescription |
No |
No |
AB |
2022/01/03
|
ALEMBIC |
| 208741 |
008 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
TABLET, DELAYED RELEASE;ORAL |
EQ 200MG BASE |
Discontinued |
No |
No |
AB |
2023/08/11
|
LUPIN |