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 |
2022/02/03 |
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: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
|
ASPEN |
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 |
218397 |
001 |
ANDA |
ACETYLCYSTEINE |
ACETYLCYSTEINE |
INJECTABLE;INTRAVENOUS |
6GM/30ML (200MG/ML) |
Prescription |
No |
No |
AP |
2024/06/07
|
SOMERSET THERAPS LLC |