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 |
|---|
| 2021/05/14 |
SUPPL-29（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/09/23 |
SUPPL-22（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/01/27 |
SUPPL-18（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2003/08/07 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2003/06/30 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2001/02/23 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2000/01/28 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/12/13 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/10/09 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/03/25 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1997/12/10 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1997/12/10 |
SUPPL-6（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1997/06/03 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1996/11/04 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1995/11/02 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/11/18 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1993/04/29 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1991/04/22 |
ORIG-1（原始申请） |
Approval |
Type 4 - New Combination |
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:POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 剂型/给药途径:FOR SOLUTION;ORAL 规格:420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/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 |
|---|
| 019797 |
001 |
NDA |
NULYTELY |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Prescription |
Yes |
Yes |
AA |
1991/04/22
|
BRAINTREE |
| 019797 |
002 |
NDA |
NULYTELY-FLAVORED |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Prescription |
Yes |
Yes |
AA |
1994/11/18
|
BRAINTREE |
| 090019 |
001 |
ANDA |
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Prescription |
No |
No |
AA |
2009/05/27
|
NOVEL LABS INC |
| 079232 |
001 |
ANDA |
LAX-LYTE WITH FLAVOR PACKS |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Discontinued |
No |
No |
AA |
2010/02/25
|
L PERRIGO CO |
| 204559 |
001 |
ANDA |
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Prescription |
No |
No |
AA |
2015/04/13
|
STRIDES PHARMA |
活性成分:POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 剂型/给药途径:FOR SOLUTION;ORAL 规格:420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/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 |
|---|
| 019797 |
001 |
NDA |
NULYTELY |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Prescription |
Yes |
Yes |
AA |
1991/04/22
|
BRAINTREE |
| 019797 |
002 |
NDA |
NULYTELY-FLAVORED |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Prescription |
Yes |
Yes |
AA |
1994/11/18
|
BRAINTREE |
| 090019 |
001 |
ANDA |
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Prescription |
No |
No |
AA |
2009/05/27
|
NOVEL LABS INC |
| 079232 |
001 |
ANDA |
LAX-LYTE WITH FLAVOR PACKS |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Discontinued |
No |
No |
AA |
2010/02/25
|
L PERRIGO CO |
| 204559 |
001 |
ANDA |
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE |
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE |
FOR SOLUTION;ORAL |
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT |
Prescription |
No |
No |
AA |
2015/04/13
|
STRIDES PHARMA |
