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 |
|---|
| 2024/06/24 |
ORIG-1（原始申请） |
Approval |
|
|
|
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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:MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE 剂型/给药途径:SOLUTION;ORAL 规格:1.6GM/BOT;3.13GM/BOT;17.5GM/BOT 治疗等效代码:AA
| 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 |
|---|
| 022372 |
001 |
NDA |
SUPREP BOWEL PREP KIT |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
SOLUTION;ORAL |
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
Prescription |
Yes |
Yes |
AA |
2010/08/05
|
BRAINTREE LABS |
| 202511 |
001 |
ANDA |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
SOLUTION;ORAL |
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
Prescription |
No |
No |
AA |
2017/02/23
|
NOVEL LABS INC |
| 215469 |
001 |
ANDA |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
SOLUTION;ORAL |
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
Prescription |
No |
No |
AA |
2023/11/22
|
STRIDES PHARMA |
| 213924 |
001 |
ANDA |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
SOLUTION;ORAL |
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
Prescription |
No |
No |
AA |
2023/12/29
|
ALKEM LABS LTD |
| 206431 |
001 |
ANDA |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
SOLUTION;ORAL |
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
Prescription |
No |
No |
AA |
2024/03/19
|
TARO |
| 204135 |
001 |
ANDA |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
SOLUTION;ORAL |
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
Prescription |
No |
No |
AA |
2024/06/24
|
BIONPHARMA |
| 209941 |
001 |
ANDA |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
SOLUTION;ORAL |
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
Prescription |
No |
No |
AA |
2024/07/15
|
PAI HOLDINGS |
| 212903 |
001 |
ANDA |
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE |
MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE |
SOLUTION;ORAL |
1.6GM/BOT;3.13GM/BOT;17.5GM/BOT |
Prescription |
No |
No |
AA |
2024/10/18
|
ANNORA PHARMA |
