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 |
|---|
| 2016/10/27 |
ORIG-1（原始申请） |
Approval |
|
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 |
|---|
| 2023/05/24 |
SUPPL-11（补充） |
Approval |
Labeling-Package Insert |
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:ACETAZOLAMIDE; 剂型/给药途径:TABLET;ORAL; 规格:125MG; 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 |
|---|
| 040195 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
1997/05/28
|
TARO |
| 205530 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2016/10/27
|
HERITAGE PHARMA |
| 209734 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2017/11/20
|
STRIDES PHARMA |
| 210588 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2019/10/17
|
NOVITIUM PHARMA |
| 207503 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Discontinued |
No |
No |
AB |
2020/04/30
|
BRECKENRIDGE |
| 214282 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2020/10/07
|
MANKIND PHARMA |
| 211372 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2021/02/22
|
APPCO |
| 215101 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2021/08/19
|
RUBICON RESEARCH |
| 211069 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2023/04/04
|
ZYDUS LIFESCIENCES |
| 217197 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2023/05/09
|
NE RX PHARMA |
| 211151 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Discontinued |
No |
No |
AB |
2023/09/11
|
AJANTA PHARMA LTD |
| 213706 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Discontinued |
No |
No |
AB |
2024/01/26
|
TORRENT |
| 218023 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2024/05/14
|
EPIC PHARMA LLC |
| 212089 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
125MG |
Prescription |
No |
No |
AB |
2025/05/30
|
AUROBINDO PHARMA LTD |
>>>活性成分:ACETAZOLAMIDE; 剂型/给药途径:TABLET;ORAL; 规格:250MG; 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 |
|---|
| 084840 |
001 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
CHARTWELL MOLECULAR |
| 040195 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
Yes |
AB |
1997/05/28
|
TARO |
| 205530 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2016/10/27
|
HERITAGE PHARMA |
| 209734 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2017/11/20
|
STRIDES PHARMA |
| 210588 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2019/10/17
|
NOVITIUM PHARMA |
| 207503 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Discontinued |
No |
No |
AB |
2020/04/30
|
BRECKENRIDGE |
| 214282 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2020/10/07
|
MANKIND PHARMA |
| 211372 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2021/02/22
|
APPCO |
| 215101 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2021/08/19
|
RUBICON RESEARCH |
| 211069 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2023/04/04
|
ZYDUS LIFESCIENCES |
| 217197 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2023/05/09
|
NE RX PHARMA |
| 211151 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Discontinued |
No |
No |
AB |
2023/09/11
|
AJANTA PHARMA LTD |
| 213706 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Discontinued |
No |
No |
AB |
2024/01/26
|
TORRENT |
| 218023 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2024/05/14
|
EPIC PHARMA LLC |
| 212089 |
002 |
ANDA |
ACETAZOLAMIDE |
ACETAZOLAMIDE |
TABLET;ORAL |
250MG |
Prescription |
No |
No |
AB |
2025/05/30
|
AUROBINDO PHARMA LTD |