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 |
2017/05/19 |
SUPPL-15(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2017/05/19 |
SUPPL-14(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2015/05/08 |
SUPPL-12(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2011/04/26 |
SUPPL-5(补充) |
Approval |
Labeling |
|
|
|
2011/03/28 |
SUPPL-3(补充) |
Approval |
Labeling |
|
|
|
2009/03/09 |
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: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 |