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 |
|---|
| 2016/01/22 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/07/22 |
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:TACROLIMUS 剂型/给药途径:CAPSULE;ORAL 规格:EQ 0.5MG 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 |
|---|
| 050708 |
003 |
NDA |
PROGRAF |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
Yes |
No |
AB |
1998/08/24
|
ASTELLAS |
| 065461 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
SANDOZ |
| 090509 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2010/05/12
|
DR REDDYS LABS LTD |
| 090596 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2010/09/17
|
MYLAN |
| 090802 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2012/09/28
|
PANACEA |
| 090687 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2014/07/22
|
STRIDES PHARMA |
| 206651 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2017/11/30
|
BELCHER |
| 206662 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/11/10
|
GLENMARK PHARMS LTD |
| 212297 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/11/10
|
BIOCON PHARMA |
| 213112 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/11/10
|
CONCORD BIOTECH LTD |
| 203740 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2020/11/12
|
ALKEM LABS LTD |
| 210929 |
001 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 0.5MG BASE |
Prescription |
No |
No |
AB |
2023/04/17
|
HANGZHOU ZHONGMEI |
活性成分:TACROLIMUS 剂型/给药途径:CAPSULE;ORAL 规格:EQ 1MG 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 |
|---|
| 050708 |
001 |
NDA |
PROGRAF |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
Yes |
No |
AB |
1994/04/08
|
ASTELLAS |
| 065461 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
SANDOZ |
| 090509 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2010/05/12
|
DR REDDYS LABS LTD |
| 090596 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2010/09/17
|
MYLAN |
| 090802 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2012/09/28
|
PANACEA |
| 090687 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2014/07/22
|
STRIDES PHARMA |
| 206651 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2017/11/30
|
BELCHER |
| 206662 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2020/11/10
|
GLENMARK PHARMS LTD |
| 212297 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2020/11/10
|
BIOCON PHARMA |
| 213112 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2020/11/10
|
CONCORD BIOTECH LTD |
| 203740 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2020/11/12
|
ALKEM LABS LTD |
| 210929 |
002 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 1MG BASE |
Prescription |
No |
No |
AB |
2023/04/17
|
HANGZHOU ZHONGMEI |
活性成分:TACROLIMUS 剂型/给药途径:CAPSULE;ORAL 规格:EQ 5MG 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 |
|---|
| 050708 |
002 |
NDA |
PROGRAF |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
Yes |
Yes |
AB |
1994/04/08
|
ASTELLAS |
| 065461 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2009/08/10
|
SANDOZ |
| 090509 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2010/05/12
|
DR REDDYS LABS LTD |
| 090596 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2010/09/17
|
MYLAN |
| 090802 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2012/09/28
|
PANACEA |
| 090687 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2014/07/22
|
STRIDES PHARMA |
| 206651 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2017/11/30
|
BELCHER |
| 206662 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2020/11/10
|
GLENMARK PHARMS LTD |
| 212297 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2020/11/10
|
BIOCON PHARMA |
| 213112 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2020/11/10
|
CONCORD BIOTECH LTD |
| 203740 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2020/11/12
|
ALKEM LABS LTD |
| 210929 |
003 |
ANDA |
TACROLIMUS |
TACROLIMUS |
CAPSULE;ORAL |
EQ 5MG BASE |
Prescription |
No |
No |
AB |
2023/04/17
|
HANGZHOU ZHONGMEI |