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 |
|---|
| 2024/09/24 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/04/17 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/07/25 |
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:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 200MG BASE/VIAL 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 |
|---|
| 078339 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
HOSPIRA |
| 078433 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
SUN PHARM |
| 078759 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
TEYRO LABS |
| 090799 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
FRESENIUS KABI USA |
| 091365 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
DR REDDYS LABS LTD |
| 091594 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Discontinued |
No |
No |
AP |
2011/07/25
|
ACCORD HLTHCARE |
| 202485 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
Yes |
AP |
2013/05/07
|
JIANGSU HANSOH PHARM |
| 204520 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2016/01/05
|
GLAND PHARMA LTD |
| 207575 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2019/02/22
|
SHILPA |
| 206617 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 200MG BASE/VIAL |
Prescription |
No |
No |
AP |
2021/06/25
|
HIKMA INTL PHARMS |
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:EQ 1GM BASE/VIAL 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 |
|---|
| 078339 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
HOSPIRA |
| 078433 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
SUN PHARM |
| 078759 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
TEYRO LABS |
| 090799 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
FRESENIUS KABI USA |
| 091365 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2011/07/25
|
DR REDDYS LABS LTD |
| 091594 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Discontinued |
No |
No |
AP |
2011/07/25
|
ACCORD HLTHCARE |
| 202485 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
Yes |
AP |
2013/05/07
|
JIANGSU HANSOH PHARM |
| 204520 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2016/01/05
|
GLAND PHARMA LTD |
| 207575 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2019/02/22
|
SHILPA |
| 206617 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1GM BASE/VIAL |
Prescription |
No |
No |
AP |
2021/06/25
|
HIKMA INTL PHARMS |