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 |
|---|
| 2021/08/13 |
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 |
|---|
| 无 |
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:CAPSULE;ORAL; 规格:300MG;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 |
|---|
| 040885 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Prescription |
No |
Yes |
AA |
2009/11/16
|
LGM PHARMA |
| 207118 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Prescription |
No |
No |
AA |
2016/10/28
|
NUVO PHARMS INC |
| 206615 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Discontinued |
No |
No |
AA |
2017/08/04
|
KEY THERAP |
| 210817 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Prescription |
No |
No |
AA |
2019/12/17
|
DR REDDYS LABS SA |
| 212082 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Prescription |
No |
No |
AA |
2019/12/17
|
LANNETT CO INC |
| 213321 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Prescription |
No |
No |
AA |
2020/04/08
|
GRANULES |
| 213046 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Prescription |
No |
No |
AA |
2020/07/01
|
TARO |
| 214087 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Prescription |
No |
No |
AA |
2021/08/13
|
SENORES PHARMS |
| 215047 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Prescription |
No |
No |
AA |
2021/11/17
|
NOVAST LABS |
| 215135 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Discontinued |
No |
No |
AA |
2022/03/25
|
HIKMA |
| 214288 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
300MG;50MG;40MG |
Prescription |
No |
No |
AA |
2024/02/08
|
QUAGEN |
>>>活性成分:ACETAMINOPHEN; BUTALBITAL; CAFFEINE; 剂型/给药途径:CAPSULE;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 |
|---|
| 089007 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
325MG;50MG;40MG |
Prescription |
No |
Yes |
AA |
1986/03/17
|
DR REDDYS LABS SA |
| 204733 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2018/09/26
|
AUROLIFE PHARMA LLC |
| 212083 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2019/12/17
|
LANNETT CO INC |
| 214087 |
002 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2021/08/13
|
SENORES PHARMS |
| 215135 |
002 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
325MG;50MG;40MG |
Discontinued |
No |
No |
AA |
2022/03/25
|
HIKMA |
| 216376 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
CAPSULE;ORAL |
325MG;50MG;40MG |
Prescription |
No |
No |
AA |
2024/03/12
|
QUAGEN |