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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2023/07/10 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 无 |
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:LEUCOVORIN CALCIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 50MG 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 |
|---|
| 089384 |
001 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
1987/09/14
|
HIKMA |
| 200753 |
001 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2012/09/06
|
SAGENT PHARMS |
| 217021 |
001 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/07/10
|
HAINAN POLY |
| 216590 |
001 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/07/19
|
MEITHEAL |
>>>活性成分:LEUCOVORIN CALCIUM; 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 |
|---|
| 089717 |
001 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
1988/03/28
|
HIKMA |
| 081277 |
001 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Discontinued |
No |
No |
AP |
1993/09/28
|
TEVA PHARMS USA |
| 200753 |
002 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2012/09/06
|
SAGENT PHARMS |
| 203800 |
001 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2017/05/19
|
MYLAN LABS LTD |
| 217021 |
002 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/07/10
|
HAINAN POLY |
| 216590 |
002 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 100MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/07/19
|
MEITHEAL |
>>>活性成分:LEUCOVORIN CALCIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 200MG 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 |
|---|
| 040056 |
001 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
1995/05/23
|
HIKMA |
| 040258 |
001 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
1999/02/26
|
FRESENIUS KABI USA |
| 200753 |
003 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2012/09/06
|
SAGENT PHARMS |
| 203800 |
002 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2017/05/19
|
MYLAN LABS LTD |
| 217021 |
003 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/07/10
|
HAINAN POLY |
| 216590 |
003 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/07/19
|
MEITHEAL |
>>>活性成分:LEUCOVORIN CALCIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 500MG 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 |
|---|
| 040286 |
001 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
1999/02/26
|
FRESENIUS KABI USA |
| 209110 |
001 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2017/10/26
|
SAGENT PHARMS INC |
| 217021 |
004 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/07/10
|
HAINAN POLY |
| 216590 |
005 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 500MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/07/19
|
MEITHEAL |
>>>活性成分:LEUCOVORIN CALCIUM; 剂型/给药途径:INJECTABLE;INJECTION; 规格:EQ 350MG 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 |
|---|
| 040174 |
001 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 350MG BASE/VIAL |
Discontinued |
No |
No |
AP |
1997/06/12
|
TEVA PHARMS USA |
| 040335 |
001 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 350MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
2000/04/20
|
HIKMA |
| 200855 |
001 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 350MG BASE/VIAL |
Prescription |
No |
No |
AP |
2012/09/06
|
SAGENT PHARMS |
| 203800 |
003 |
ANDA |
LEUCOVORIN CALCIUM PRESERVATIVE FREE |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 350MG BASE/VIAL |
Prescription |
No |
No |
AP |
2017/05/19
|
MYLAN LABS LTD |
| 216590 |
004 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 350MG BASE/VIAL |
Prescription |
No |
No |
AP |
2023/07/19
|
MEITHEAL |
| 217021 |
005 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 350MG BASE/VIAL |
Prescription |
No |
No |
AP |
2024/12/19
|
HAINAN POLY |
| 218200 |
001 |
ANDA |
LEUCOVORIN CALCIUM |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 350MG BASE/VIAL |
Prescription |
No |
No |
AP |
2025/11/12
|
GLAND |