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 |
|---|
| 2019/10/04 |
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:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:200MG/5.26ML (38MG/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 |
|---|
| 200795 |
001 |
NDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/5.26ML (38MG/ML) |
Prescription |
Yes |
Yes |
AP |
2011/08/04
|
HOSPIRA INC |
| 205242 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/5.26ML (38MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
MYLAN LABS LTD |
| 209077 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/5.26ML (38MG/ML) |
Prescription |
No |
No |
AP |
2018/07/20
|
SAGENT PHARMS INC |
| 210383 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/5.26ML (38MG/ML) |
Prescription |
No |
No |
AP |
2019/02/14
|
NOVAST LABS |
| 210991 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/5.26ML (38MG/ML) |
Prescription |
No |
No |
AP |
2019/10/04
|
SHILPA |
| 212129 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/5.26ML (38MG/ML) |
Prescription |
No |
No |
AP |
2020/12/11
|
MEITHEAL |
| 213175 |
001 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
200MG/5.26ML (38MG/ML) |
Prescription |
No |
No |
AP |
2023/03/07
|
HIKMA |
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:1GM/26.3ML (38MG/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 |
|---|
| 200795 |
002 |
NDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1GM/26.3ML (38MG/ML) |
Prescription |
Yes |
Yes |
AP |
2011/08/04
|
HOSPIRA INC |
| 205242 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1GM/26.3ML (38MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
MYLAN LABS LTD |
| 209077 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1GM/26.3ML (38MG/ML) |
Prescription |
No |
No |
AP |
2018/07/20
|
SAGENT PHARMS INC |
| 210383 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1GM/26.3ML (38MG/ML) |
Prescription |
No |
No |
AP |
2019/02/14
|
NOVAST LABS |
| 210991 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1GM/26.3ML (38MG/ML) |
Prescription |
No |
No |
AP |
2019/10/04
|
SHILPA |
| 212129 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1GM/26.3ML (38MG/ML) |
Prescription |
No |
No |
AP |
2020/12/11
|
MEITHEAL |
| 213175 |
002 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
1GM/26.3ML (38MG/ML) |
Prescription |
No |
No |
AP |
2023/03/07
|
HIKMA |
活性成分:GEMCITABINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:2GM/52.6ML (38MG/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 |
|---|
| 200795 |
003 |
NDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2GM/52.6ML (38MG/ML) |
Prescription |
Yes |
Yes |
AP |
2011/08/04
|
HOSPIRA INC |
| 205242 |
003 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2GM/52.6ML (38MG/ML) |
Prescription |
No |
No |
AP |
2017/12/06
|
MYLAN LABS LTD |
| 209077 |
003 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2GM/52.6ML (38MG/ML) |
Prescription |
No |
No |
AP |
2018/07/20
|
SAGENT PHARMS INC |
| 210383 |
003 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2GM/52.6ML (38MG/ML) |
Prescription |
No |
No |
AP |
2019/02/14
|
NOVAST LABS |
| 210991 |
003 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2GM/52.6ML (38MG/ML) |
Prescription |
No |
No |
AP |
2019/10/04
|
SHILPA |
| 212129 |
003 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2GM/52.6ML (38MG/ML) |
Prescription |
No |
No |
AP |
2020/12/11
|
MEITHEAL |
| 213175 |
003 |
ANDA |
GEMCITABINE HYDROCHLORIDE |
GEMCITABINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
2GM/52.6ML (38MG/ML) |
Prescription |
No |
No |
AP |
2023/03/07
|
HIKMA |