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 |
|---|
| 2020/09/29 |
SUPPL-9（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2020/06/08 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/10/12 |
SUPPL-1（补充） |
Approval |
Labeling |
|
|
|
| 2011/06/08 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
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:HEPARIN SODIUM 剂型/给药途径:INJECTABLE;INJECTION 规格:10,000 UNITS/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 |
|---|
| 017037 |
003 |
NDA |
HEPARIN SODIUM |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
HIKMA |
| 017029 |
003 |
NDA |
HEPARIN SODIUM |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
FRESENIUS KABI USA |
| 017029 |
015 |
NDA |
HEPARIN SODIUM IN PLASTIC CONTAINER |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
Yes |
Yes |
AP |
1985/12/05
|
FRESENIUS KABI USA |
| 089522 |
001 |
ANDA |
HEPARIN SODIUM PRESERVATIVE FREE |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
No |
No |
AP |
1987/05/04
|
HOSPIRA |
| 090571 |
003 |
ANDA |
HEPARIN SODIUM |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
No |
No |
AP |
2009/08/31
|
HOSPIRA INC |
| 090808 |
003 |
ANDA |
HEPARIN SODIUM |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
No |
No |
AP |
2010/06/30
|
SAGENT PHARMS |
| 017029 |
019 |
NDA |
HEPARIN SODIUM PRESERVATIVE FREE |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
Yes |
Yes |
AP |
2010/11/22
|
FRESENIUS KABI USA |
| 201002 |
001 |
ANDA |
HEPARIN SODIUM |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
No |
No |
AP |
2011/06/08
|
SANDOZ |
| 203198 |
001 |
ANDA |
HEPARIN SODIUM |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
No |
No |
AP |
2014/06/12
|
SHENZHEN TECHDOW |
| 203851 |
003 |
ANDA |
HEPARIN SODIUM |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
No |
No |
AP |
2017/11/30
|
MYLAN LABS LTD |
| 211007 |
003 |
ANDA |
HEPARIN SODIUM |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
No |
No |
AP |
2019/05/28
|
NANJING KING-FRIEND |
| 212060 |
001 |
ANDA |
HEPARIN SODIUM PRESERVATIVE FREE |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
No |
No |
AP |
2020/04/02
|
NANJING KING-FRIEND |
| 214839 |
001 |
ANDA |
HEPARIN SODIUM |
HEPARIN SODIUM |
INJECTABLE;INJECTION |
10,000 UNITS/ML |
Prescription |
No |
No |
AP |
2020/12/29
|
BE PHARMS |