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 |
|---|
| 2024/01/18 |
ORIG-1（原始申请） |
Approval |
|
STANDARD
|
|
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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:ACETAMINOPHEN; BUTALBITAL; CAFFEINE 剂型/给药途径:TABLET;ORAL 规格:325MG;50MG;40MG 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 |
|---|
| 088616 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Prescription |
Yes |
No |
AA |
1984/11/09
|
ACTAVIS LABS UT INC |
| 089175 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
1987/01/21
|
MIKART |
| 040511 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Prescription |
No |
Yes |
AA |
2003/08/27
|
STRIDES PHARMA |
| 040864 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2008/12/01
|
GRANULES |
| 200243 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2012/09/13
|
LANNETT CO INC |
| 204984 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Discontinued |
No |
No |
AA |
2017/01/10
|
ALVOGEN |
| 211106 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2018/09/26
|
ABHAI LLC |
| 209587 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2018/10/31
|
LGM PHARMA |
| 203647 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2020/09/21
|
STRIDES PHARMA |
| 214287 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
TABLET;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2024/01/18
|
QUAGEN |