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 |
|---|
| 2013/10/18 |
SUPPL-45（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2011/06/22 |
SUPPL-44（补充） |
Approval |
Labeling |
|
|
|
| 2009/06/22 |
SUPPL-42（补充） |
Approval |
Labeling |
|
|
|
| 2002/11/20 |
SUPPL-35（补充） |
Approval |
Labeling |
|
|
|
| 2002/08/13 |
SUPPL-34（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/03/28 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/07/31 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/06/26 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/06/27 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 1997/06/27 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/06/27 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/06/27 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/06/27 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/01/15 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/01/15 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/03/25 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/03/25 |
SUPPL-19（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/10/16 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/10/16 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/08/18 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/02/08 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/11/17 |
SUPPL-17（补充） |
Approval |
Labeling |
|
|
|
| 1993/11/17 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 1993/11/17 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/01/31 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1991/08/02 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1991/08/02 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/07/14 |
SUPPL-12（补充） |
Approval |
Labeling |
|
|
|
| 1989/07/14 |
SUPPL-11（补充） |
Approval |
Labeling |
|
|
|
| 1989/06/02 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/12/30 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/07/12 |
SUPPL-6（补充） |
Approval |
Labeling |
|
|
|
| 1988/05/20 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/05/20 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/05/20 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/05/20 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/11/02 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/01/21 |
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: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 |