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 |
|---|
| 1992/07/30 |
ORIG-1（原始申请） |
Approval |
Type 5 - New Formulation or New Manufacturer |
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 |
|---|
| 2024/10/31 |
SUPPL-48（补充） |
Approval |
REMS - MODIFIED - D-N-A |
N/A
|
|
|
| 2023/12/15 |
SUPPL-47（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2021/03/04 |
SUPPL-45（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2019/10/07 |
SUPPL-44（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-43（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-42（补充） |
Approval |
REMS - PROPOSAL - D-N-A |
N/A
|
|
|
| 2017/08/29 |
SUPPL-41（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-40（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert,Labeling-Package Insert |
STANDARD
|
|
|
| 2015/07/31 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2015/06/16 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2014/06/05 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 2013/10/18 |
SUPPL-36（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2013/05/09 |
SUPPL-35（补充） |
Approval |
Labeling-Package Insert |
901 REQUIRED
|
|
|
| 2011/06/22 |
SUPPL-33（补充） |
Approval |
Labeling-Package Insert |
UNKNOWN
|
|
|
| 2008/03/21 |
SUPPL-21（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2002/04/26 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2002/01/03 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2001/10/04 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2001/05/30 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC)-Control |
STANDARD
|
|
|
| 2001/05/22 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/08/03 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1999/04/22 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1998/05/20 |
SUPPL-8（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1996/01/18 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 1995/11/08 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
STANDARD
|
|
|
| 1994/03/29 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC)-Packaging |
STANDARD
|
|
|
| 1992/12/01 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC)-Control |
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:ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE; 剂型/给药途径:CAPSULE;ORAL; 规格:325MG;50MG;40MG;30MG; 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 |
|---|
| 020232 |
001 |
NDA |
FIORICET W/ CODEINE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
CAPSULE;ORAL |
325MG;50MG;40MG;30MG |
Prescription |
Yes |
Yes |
AB |
1992/07/30
|
ACTAVIS LABS UT INC |
| 075929 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
CAPSULE;ORAL |
325MG;50MG;40MG;30MG |
Discontinued |
No |
No |
AB |
2002/04/22
|
PHARMOBEDIENT |
| 076560 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
CAPSULE;ORAL |
325MG;50MG;40MG;30MG |
Prescription |
No |
No |
AB |
2004/06/10
|
LGM PHARMA |
| 204649 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
CAPSULE;ORAL |
325MG;50MG;40MG;30MG |
Prescription |
No |
No |
AB |
2020/07/08
|
STRIDES PHARMA |
| 215138 |
001 |
ANDA |
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE |
CAPSULE;ORAL |
325MG;50MG;40MG;30MG |
Prescription |
No |
No |
AB |
2022/01/26
|
HIKMA |
