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 |
|---|
| 2000/10/25 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>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 |
|---|
| 2025/09/23 |
SUPPL-45（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2025/09/19 |
SUPPL-38（补充） |
Approval |
Labeling-Package Insert,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2025/09/19 |
SUPPL-37（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide,Labeling-Patient Package Insert |
STANDARD
|
|
|
| 2017/05/19 |
SUPPL-36（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2017/05/19 |
SUPPL-35（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2017/05/19 |
SUPPL-33（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2013/01/31 |
SUPPL-26（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2012/08/09 |
SUPPL-24（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 2011/03/28 |
SUPPL-16（补充） |
Approval |
Labeling-Package Insert |
|
|
|
| 2009/05/27 |
SUPPL-7（补充） |
Approval |
Labeling |
|
|
|
| 2001/09/20 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC)-Control |
|
|
|
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:LEUPROLIDE ACETATE; 剂型/给药途径:SOLUTION;SUBCUTANEOUS; 规格:14MG/2.8ML (1MG/0.2ML); 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 |
|---|
| 074728 |
001 |
ANDA |
LEUPROLIDE ACETATE |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
Prescription |
No |
Yes |
AP |
1998/08/04
|
SANDOZ |
| 075471 |
001 |
ANDA |
LEUPROLIDE ACETATE |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
Prescription |
No |
No |
AP |
2000/10/25
|
MEITHEAL |
| 078885 |
001 |
ANDA |
LEUPROLIDE ACETATE |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
Prescription |
No |
No |
AP |
2009/03/09
|
SUN PHARM |
| 213829 |
001 |
ANDA |
LEUPROLIDE ACETATE |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
Prescription |
No |
No |
AP |
2021/08/13
|
RK PHARMA |
| 212963 |
001 |
ANDA |
LEUPROLIDE ACETATE |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
Prescription |
No |
No |
AP |
2022/06/06
|
EUGIA PHARMA |
| 215336 |
001 |
ANDA |
LEUPROLIDE ACETATE |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
Prescription |
No |
No |
AP |
2022/10/28
|
AMNEAL |
| 217957 |
001 |
ANDA |
LEUPROLIDE ACETATE |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
Prescription |
No |
No |
AP |
2024/10/17
|
UBI |
| 217437 |
001 |
ANDA |
LEUPROLIDE ACETATE |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
Discontinued |
No |
No |
AP |
2025/06/09
|
PH HEALTH |
| 215826 |
001 |
ANDA |
LEUPROLIDE ACETATE |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
Prescription |
No |
No |
AP |
2025/11/13
|
ZYDUS PHARMS |
