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 |
2024/07/09 |
SUPPL-6(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/02/21 |
SUPPL-3(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2023/02/21 |
SUPPL-2(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2020/02/03 |
SUPPL-1(补充) |
Approval |
Labeling |
STANDARD
|
|
|
2018/09/07 |
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:OCTREOTIDE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 0.2MG BASE/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 |
076330 |
001 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.2MG BASE/ML |
Prescription |
No |
Yes |
AP |
2005/04/08
|
WEST-WARD PHARMS INT |
075959 |
001 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.2MG BASE/ML |
Prescription |
No |
No |
AP |
2005/11/21
|
MEITHEAL |
077450 |
001 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.2MG BASE/ML |
Prescription |
No |
No |
AP |
2006/02/10
|
FRESENIUS KABI USA |
091041 |
001 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.2MG BASE/ML |
Prescription |
No |
No |
AP |
2013/11/12
|
SAGENT PHARMS INC |
203765 |
001 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.2MG BASE/ML |
Prescription |
No |
No |
AP |
2018/09/07
|
HERITAGE |
216807 |
001 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.2MG BASE/ML |
Prescription |
No |
No |
AP |
2023/06/13
|
GLAND PHARMA LTD |
活性成分:OCTREOTIDE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1MG BASE/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 |
076330 |
002 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
Yes |
AP |
2005/04/08
|
WEST-WARD PHARMS INT |
075959 |
002 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2005/11/21
|
MEITHEAL |
077450 |
002 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2006/02/10
|
FRESENIUS KABI USA |
091041 |
002 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2013/11/12
|
SAGENT PHARMS INC |
203765 |
002 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2018/09/07
|
HERITAGE |
216807 |
002 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML |
Prescription |
No |
No |
AP |
2023/06/13
|
GLAND PHARMA LTD |