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 |
|---|
| 2016/11/08 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/09/18 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/09/15 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/08/06 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/08/06 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/04/18 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2010/04/09 |
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:GRANISETRON HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 0.1MG BASE/ML (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 |
|---|
| 078262 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
Prescription |
No |
No |
AP |
2007/12/31
|
AMNEAL |
| 078392 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
Prescription |
No |
Yes |
AP |
2007/12/31
|
DR REDDYS |
| 078522 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
Prescription |
No |
No |
AP |
2007/12/31
|
FRESENIUS KABI USA |
| 077913 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
Prescription |
No |
No |
AP |
2008/06/26
|
HIKMA |
| 078863 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
Prescription |
No |
No |
AP |
2008/06/30
|
BIONPHARMA |
| 078534 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
Prescription |
No |
No |
AP |
2009/04/30
|
SANDOZ |
| 079119 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
Discontinued |
No |
No |
AP |
2009/09/10
|
EPIC PHARMA LLC |
| 091136 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) |
Prescription |
No |
No |
AP |
2010/04/09
|
MYLAN ASI |
活性成分:GRANISETRON HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1MG BASE/ML (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 |
|---|
| 077187 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2008/06/30
|
HIKMA |
| 078096 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Prescription |
No |
Yes |
AP |
2008/06/30
|
FRESENIUS KABI USA |
| 078258 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2008/06/30
|
AMNEAL |
| 078835 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2008/06/30
|
SANDOZ INC |
| 078863 |
002 |
ANDA |
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2008/06/30
|
BIONPHARMA |
| 078531 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2009/04/30
|
SANDOZ |
| 079078 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2009/09/14
|
RISING |
| 078629 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2009/12/23
|
HIKMA FARMACEUTICA |
| 091136 |
002 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Prescription |
No |
No |
AP |
2010/04/09
|
MYLAN ASI |
| 204238 |
001 |
ANDA |
GRANISETRON HYDROCHLORIDE |
GRANISETRON HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/ML (EQ 1MG BASE/ML) |
Discontinued |
No |
No |
AP |
2016/07/06
|
EUGIA PHARMA |