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 |
|---|
| 2024/10/25 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/06/14 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2023/06/22 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
|
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 0.5MG 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 |
|---|
| 019667 |
003 |
NDA |
SANDOSTATIN |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.5MG BASE/ML |
Prescription |
Yes |
Yes |
AP |
1988/10/21
|
NOVARTIS |
| 076313 |
002 |
ANDA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.5MG BASE/ML |
Prescription |
No |
Yes |
AP |
2005/03/28
|
WEST-WARD PHARMS INT |
| 075957 |
003 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.5MG BASE/ML |
Prescription |
No |
No |
AP |
2005/10/03
|
MEITHEAL |
| 077457 |
003 |
ANDA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.5MG BASE/ML |
Prescription |
No |
No |
AP |
2006/02/10
|
FRESENIUS KABI USA |
| 079198 |
003 |
ANDA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.5MG BASE/ML |
Prescription |
No |
No |
AP |
2011/02/10
|
MYLAN INSTITUTIONAL |
| 090834 |
003 |
ANDA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.5MG BASE/ML |
Prescription |
No |
No |
AP |
2013/11/12
|
SAGENT PHARMS INC |
| 204669 |
003 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.5MG BASE/ML |
Prescription |
No |
No |
AP |
2018/12/27
|
HERITAGE |
| 216839 |
001 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.5MG BASE/ML |
Prescription |
No |
No |
AP |
2023/06/22
|
GLAND PHARMA LTD |
活性成分:OCTREOTIDE ACETATE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 0.1MG 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 |
|---|
| 019667 |
002 |
NDA |
SANDOSTATIN |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML |
Prescription |
Yes |
Yes |
AP |
1988/10/21
|
NOVARTIS |
| 076313 |
003 |
ANDA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML |
Prescription |
No |
Yes |
AP |
2005/03/28
|
WEST-WARD PHARMS INT |
| 075957 |
002 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML |
Prescription |
No |
No |
AP |
2005/10/03
|
MEITHEAL |
| 077457 |
002 |
ANDA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML |
Prescription |
No |
No |
AP |
2006/02/10
|
FRESENIUS KABI USA |
| 079198 |
002 |
ANDA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML |
Prescription |
No |
No |
AP |
2011/02/10
|
MYLAN INSTITUTIONAL |
| 090834 |
002 |
ANDA |
OCTREOTIDE ACETATE (PRESERVATIVE FREE) |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML |
Prescription |
No |
No |
AP |
2013/11/12
|
SAGENT PHARMS INC |
| 204669 |
002 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML |
Prescription |
No |
No |
AP |
2018/12/27
|
HERITAGE |
| 216839 |
002 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML |
Prescription |
No |
No |
AP |
2023/06/22
|
GLAND PHARMA LTD |
| 217860 |
001 |
ANDA |
OCTREOTIDE ACETATE |
OCTREOTIDE ACETATE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML |
Discontinued |
No |
No |
AP |
2024/05/02
|
SHUANGCHENG |