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 |
|---|
| 2019/08/19 |
SUPPL-2（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/08/19 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2015/03/24 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
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:ACETYLCYSTEINE 剂型/给药途径:INJECTABLE;INTRAVENOUS 规格:6GM/30ML (200MG/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 |
|---|
| 021539 |
001 |
NDA |
ACETADOTE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
Yes |
Yes |
AP |
2004/01/23
|
CUMBERLAND PHARMS |
| 200644 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2012/11/07
|
FRESENIUS KABI USA |
| 203173 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2015/03/24
|
RISING |
| 207358 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2016/02/29
|
EUGIA PHARMA |
| 091684 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2017/10/31
|
SAGENT PHARMS INC |
| 208166 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2018/07/20
|
ZYDUS PHARMS |
| 213693 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2022/02/03
|
GLENMARK PHARMS INC |
| 215620 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2022/02/23
|
INDOCO |
| 217182 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2023/04/19
|
STERISCIENCE SPECLTS |
| 218397 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2024/06/07
|
SOMERSET THERAPS LLC |