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 |
|---|
| 2018/11/02 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2018/11/02 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
UNKNOWN
|
|
|
| 2014/04/25 |
SUPPL-32（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/06/01 |
SUPPL-31（补充） |
Approval |
Labeling |
|
|
|
| 2001/05/24 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/02/14 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 1999/12/21 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/05/20 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/12/01 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/10/08 |
SUPPL-26（补充） |
Approval |
Labeling |
|
|
|
| 1998/09/25 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/09/22 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/12/23 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/10/11 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/07/01 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 1992/04/29 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/04/03 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/04/03 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/02/25 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 1978/11/27 |
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:ERYTHROMYCIN ETHYLSUCCINATE 剂型/给药途径:GRANULE;ORAL 规格:EQ 200MG BASE/5ML 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 |
|---|
| 062055 |
001 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
ANI PHARMS |
| 050207 |
001 |
NDA |
E.E.S. |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
CARNEGIE |
| 050207 |
003 |
NDA |
ERYPED |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
Yes |
No |
AB |
1987/03/30
|
CARNEGIE |
| 062055 |
003 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
No |
No |
AB |
2018/11/02
|
ANI PHARMS |
| 211204 |
001 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
No |
No |
AB |
2019/11/01
|
AMNEAL PHARMS |
| 216212 |
001 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
No |
No |
AB |
2022/11/21
|
CADILA PHARMS LTD |
活性成分:ERYTHROMYCIN ETHYLSUCCINATE 剂型/给药途径:GRANULE;ORAL 规格:EQ 400MG BASE/5ML 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 |
|---|
| 050207 |
002 |
NDA |
ERYPED |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 400MG BASE/5ML |
Prescription |
Yes |
Yes |
AB |
Approved Prior to Jan 1, 1982
|
CARNEGIE |
| 062055 |
002 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 400MG BASE/5ML |
Prescription |
No |
No |
AB |
2018/11/02
|
ANI PHARMS |
| 211204 |
002 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 400MG BASE/5ML |
Prescription |
No |
No |
AB |
2019/11/01
|
AMNEAL PHARMS |
| 216212 |
002 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 400MG BASE/5ML |
Prescription |
No |
No |
AB |
2022/11/21
|
CADILA PHARMS LTD |
活性成分:ERYTHROMYCIN ETHYLSUCCINATE 剂型/给药途径:GRANULE;ORAL 规格:EQ 200MG BASE/5ML 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 |
|---|
| 062055 |
001 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
ANI PHARMS |
| 050207 |
001 |
NDA |
E.E.S. |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
CARNEGIE |
| 050207 |
003 |
NDA |
ERYPED |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
Yes |
No |
AB |
1987/03/30
|
CARNEGIE |
| 062055 |
003 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
No |
No |
AB |
2018/11/02
|
ANI PHARMS |
| 211204 |
001 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
No |
No |
AB |
2019/11/01
|
AMNEAL PHARMS |
| 216212 |
001 |
ANDA |
ERYTHROMYCIN ETHYLSUCCINATE |
ERYTHROMYCIN ETHYLSUCCINATE |
GRANULE;ORAL |
EQ 200MG BASE/5ML |
Prescription |
No |
No |
AB |
2022/11/21
|
CADILA PHARMS LTD |
