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 |
|---|
| 2022/12/07 |
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:INJECTABLE;INJECTION 规格:EQ 100MG BASE/VIAL 治疗等效代码:AP
| 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 |
|---|
| 062475 |
001 |
ANDA |
DOXY 100 |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
1983/12/09
|
FRESENIUS KABI USA |
| 062569 |
001 |
ANDA |
DOXYCYCLINE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Discontinued |
No |
No |
AP |
1988/03/09
|
HIKMA |
| 062992 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
1989/02/16
|
WEST-WARD PHARMS INT |
| 091406 |
001 |
ANDA |
DOXYCYCLINE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2012/08/21
|
MYLAN LABS LTD |
| 207757 |
001 |
ANDA |
DOXYCYCLINE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
2017/09/28
|
ZYDUS PHARMS |
| 216690 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2022/12/07
|
ENDO OPERATIONS |
| 215583 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/04/12
|
GLAND PHARMA LTD |
| 217794 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/03/14
|
LUPIN LTD |
| 217685 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/06/21
|
SLATE RUN PHARMA |
| 217854 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/07/23
|
HERITAGE |
| 218053 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/10/28
|
KINDOS |
| 217487 |
001 |
ANDA |
DOXYCYCLINE HYCLATE |
DOXYCYCLINE HYCLATE |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/12/04
|
AMNEAL |