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 |
|---|
| 2019/07/24 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/10/09 |
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:PARICALCITOL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:0.002MG/ML (0.002MG/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 |
|---|
| 020819 |
002 |
NDA |
ZEMPLAR |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.002MG/ML (0.002MG/ML) |
Prescription |
Yes |
Yes |
AP |
2000/02/01
|
ABBVIE |
| 091108 |
001 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.002MG/ML (0.002MG/ML) |
Prescription |
No |
No |
AP |
2011/07/27
|
SANDOZ |
| 201657 |
001 |
NDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.002MG/ML (0.002MG/ML) |
Prescription |
No |
No |
AP |
2014/10/21
|
HOSPIRA |
| 205917 |
001 |
NDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.002MG/ML (0.002MG/ML) |
Prescription |
No |
No |
AP |
2014/11/18
|
HIKMA PHARMS |
| 207174 |
001 |
NDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.002MG/ML (0.002MG/ML) |
Prescription |
No |
No |
AP |
2016/02/04
|
ACCORD HLTHCARE |
| 204910 |
001 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.002MG/ML (0.002MG/ML) |
Prescription |
No |
No |
AP |
2016/08/17
|
DR REDDYS |
| 206699 |
001 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.002MG/ML (0.002MG/ML) |
Prescription |
No |
No |
AP |
2017/03/09
|
AMNEAL PHARMS CO |
| 205982 |
001 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.002MG/ML (0.002MG/ML) |
Prescription |
No |
No |
AP |
2018/10/09
|
EUGIA PHARMA |
活性成分:PARICALCITOL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:0.005MG/ML (0.005MG/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 |
|---|
| 020819 |
001 |
NDA |
ZEMPLAR |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.005MG/ML (0.005MG/ML) |
Prescription |
Yes |
Yes |
AP |
1998/04/17
|
ABBVIE |
| 091108 |
002 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.005MG/ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2011/07/27
|
SANDOZ |
| 201657 |
002 |
NDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.005MG/ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2014/10/21
|
HOSPIRA |
| 205917 |
002 |
NDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.005MG/ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2014/11/18
|
HIKMA PHARMS |
| 207174 |
002 |
NDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.005MG/ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2016/02/04
|
ACCORD HLTHCARE |
| 204910 |
002 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.005MG/ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2016/08/17
|
DR REDDYS |
| 206699 |
002 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.005MG/ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2017/03/09
|
AMNEAL PHARMS CO |
| 203897 |
002 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.005MG/ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2017/11/02
|
RISING |
| 205982 |
002 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.005MG/ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2018/10/09
|
EUGIA PHARMA |
活性成分:PARICALCITOL 剂型/给药途径:SOLUTION;INTRAVENOUS 规格:0.01MG/2ML (0.005MG/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 |
|---|
| 020819 |
003 |
NDA |
ZEMPLAR |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Prescription |
Yes |
Yes |
AP |
2000/02/01
|
ABBVIE |
| 091108 |
003 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2011/07/27
|
SANDOZ |
| 201657 |
003 |
NDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2014/10/21
|
HOSPIRA |
| 205917 |
003 |
NDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2014/11/18
|
HIKMA PHARMS |
| 207174 |
003 |
NDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2016/02/04
|
ACCORD HLTHCARE |
| 204910 |
003 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2016/08/17
|
DR REDDYS |
| 206699 |
003 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2017/03/09
|
AMNEAL PHARMS CO |
| 207692 |
001 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Discontinued |
No |
No |
AP |
2017/10/16
|
EPIC PHARMA LLC |
| 203897 |
003 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2017/11/02
|
RISING |
| 205982 |
003 |
ANDA |
PARICALCITOL |
PARICALCITOL |
SOLUTION;INTRAVENOUS |
0.01MG/2ML (0.005MG/ML) |
Prescription |
No |
No |
AP |
2018/10/09
|
EUGIA PHARMA |