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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 2006/03/16 |
ORIG-1（原始申请） |
Approval |
Type 3 - New Dosage Form |
STANDARD
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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 |
|---|
| 2018/11/29 |
SUPPL-14（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2016/06/21 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/09/15 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2012/10/05 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/12/09 |
SUPPL-9（补充） |
Approval |
REMS-Modified |
N/A
|
|
|
| 2009/10/13 |
SUPPL-4（补充） |
Approval |
REMS-Proposal,Labeling |
STANDARD
|
|
|
| 2009/03/25 |
SUPPL-3（补充） |
Approval |
Labeling |
901 REQUIRED
|
|
|
| 2008/12/10 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2007/09/18 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
与本品治疗等效的药品
>>>活性成分:SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE; 剂型/给药途径:TABLET;ORAL; 规格:0.398GM;1.102GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 治疗等效代码:AB<<<
| 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 |
|---|
| 021892 |
001 |
NDA |
OSMOPREP |
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
TABLET;ORAL |
0.398GM;1.102GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** |
Discontinued |
Yes |
No |
AB |
2006/03/16
|
SALIX PHARMS |
