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 |
|---|
| 2023/06/01 |
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:MYCOPHENOLATE MOFETIL HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:500MG/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 |
|---|
| 050758 |
001 |
NDA |
CELLCEPT |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
Yes |
Yes |
AP |
1998/08/12
|
ROCHE PALO |
| 203575 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2016/10/28
|
ENDO OPERATIONS |
| 204043 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2017/02/28
|
RISING |
| 203859 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2017/03/31
|
MYLAN LABS LTD |
| 204473 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2017/08/31
|
ZYDUS PHARMS |
| 212130 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2021/01/15
|
MEITHEAL |
| 216390 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2022/12/23
|
STERISCIENCE SPECLTS |
| 214283 |
001 |
ANDA |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
500MG/VIAL |
Prescription |
No |
No |
AP |
2023/06/01
|
BPI LABS |
