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 |
|---|
| 2024/08/28 |
SUPPL-30（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/07/25 |
SUPPL-27（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/07/25 |
SUPPL-26（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2009/03/27 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 2002/03/25 |
SUPPL-2（补充） |
Approval |
Labeling |
|
|
|
| 1998/08/10 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/10/15 |
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:DESMOPRESSIN ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:0.004MG/ML 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 |
|---|
| 018938 |
001 |
NDA |
DDAVP |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Prescription |
Yes |
Yes |
AP |
1984/03/30
|
FERRING PHARMS INC |
| 074888 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Prescription |
No |
No |
AP |
1997/10/15
|
MEITHEAL |
| 091280 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Discontinued |
No |
No |
AP |
2013/01/25
|
SUN PHARM INDS LTD |
| 204695 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Prescription |
No |
No |
AP |
2017/08/22
|
SAGENT PHARMS INC |
| 204751 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Prescription |
No |
No |
AP |
2017/08/22
|
SAGENT PHARMS INC |
| 091374 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Discontinued |
No |
No |
AP |
2019/02/14
|
AM REGENT |
| 210218 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Prescription |
No |
No |
AP |
2020/02/14
|
UBI |
| 210223 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Prescription |
No |
No |
AP |
2020/09/17
|
UBI |
| 215961 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Prescription |
No |
No |
AP |
2022/08/19
|
DR REDDYS |
| 216922 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Prescription |
No |
No |
AP |
2022/11/16
|
GLAND PHARMA LTD |
| 216904 |
001 |
ANDA |
DESMOPRESSIN ACETATE |
DESMOPRESSIN ACETATE |
INJECTABLE;INJECTION |
0.004MG/ML |
Prescription |
No |
No |
AP |
2023/03/20
|
GLAND |