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 |
|---|
| 2024/10/15 |
SUPPL-36（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/05/07 |
SUPPL-33（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/05/07 |
SUPPL-32（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/09/12 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/09/12 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/05/20 |
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:METHYLPREDNISOLONE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:40MG/ML 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 |
|---|
| 011757 |
001 |
NDA |
DEPO-MEDROL |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 040557 |
001 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
No |
No |
AB |
2005/02/23
|
HONG KONG |
| 040620 |
001 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Discontinued |
No |
No |
AB |
2006/10/27
|
TEVA PHARMS USA |
| 040719 |
001 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
No |
No |
AB |
2009/01/29
|
SANDOZ |
| 040794 |
001 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
No |
No |
AB |
2009/03/05
|
SANDOZ |
| 201835 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
No |
Yes |
AB |
2018/06/27
|
SAGENT PHARMS INC |
| 210043 |
001 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
No |
Yes |
AB |
2019/05/20
|
AMNEAL |
| 214297 |
001 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
No |
No |
AB |
2022/01/21
|
ENDO OPERATIONS |
| 211930 |
001 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
No |
No |
AB |
2023/04/13
|
EUGIA PHARMA |
| 214870 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
No |
No |
AB |
2023/05/10
|
WILSHIRE PHARMS INC |
| 216502 |
001 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
40MG/ML |
Prescription |
No |
No |
AB |
2023/11/03
|
AMNEAL |
活性成分:METHYLPREDNISOLONE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:80MG/ML 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 |
|---|
| 011757 |
004 |
NDA |
DEPO-MEDROL |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
Yes |
No |
AB |
Approved Prior to Jan 1, 1982
|
PFIZER |
| 040557 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
No |
No |
AB |
2005/02/23
|
HONG KONG |
| 040620 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Discontinued |
No |
No |
AB |
2006/10/27
|
TEVA PHARMS USA |
| 040719 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
No |
No |
AB |
2009/01/29
|
SANDOZ |
| 040794 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
No |
No |
AB |
2009/03/05
|
SANDOZ |
| 201835 |
003 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
No |
Yes |
AB |
2018/06/27
|
SAGENT PHARMS INC |
| 210043 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
No |
Yes |
AB |
2019/05/20
|
AMNEAL |
| 214297 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
No |
No |
AB |
2022/01/21
|
ENDO OPERATIONS |
| 214870 |
001 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
No |
No |
AB |
2023/01/03
|
WILSHIRE PHARMS INC |
| 211930 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
No |
No |
AB |
2023/04/13
|
EUGIA PHARMA |
| 216502 |
002 |
ANDA |
METHYLPREDNISOLONE ACETATE |
METHYLPREDNISOLONE ACETATE |
INJECTABLE;INJECTION |
80MG/ML |
Prescription |
No |
No |
AB |
2023/11/03
|
AMNEAL |