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 |
|---|
| 2024/10/31 |
SUPPL-18（补充） |
Approval |
REMS |
|
|
|
| 2024/03/06 |
SUPPL-17（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/03/05 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/03/05 |
SUPPL-15（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2024/03/05 |
SUPPL-14（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2021/03/04 |
SUPPL-13（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2019/10/07 |
SUPPL-12（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/20 |
SUPPL-11（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-9（补充） |
Approval |
REMS |
|
|
|
| 2017/09/29 |
SUPPL-7（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-5（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-4（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/10/18 |
SUPPL-3（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/04/15 |
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; CODEINE PHOSPHATE 剂型/给药途径:TABLET;ORAL 规格:300MG;15MG 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 |
|---|
| 088629 |
002 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;15MG |
Discontinued |
No |
No |
AA |
1985/03/06
|
NOSTRUM LABS INC |
| 089990 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;15MG |
Prescription |
No |
No |
AA |
1988/09/30
|
STRIDES PHARMA |
| 040419 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;15MG |
Prescription |
No |
Yes |
AA |
2001/05/31
|
SPECGX LLC |
| 202800 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;15MG |
Prescription |
No |
No |
AA |
2013/04/15
|
AUROLIFE PHARMA LLC |
| 211610 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;15MG |
Prescription |
No |
No |
AA |
2019/06/27
|
WES PHARMA INC |
| 212418 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;15MG |
Prescription |
No |
No |
AA |
2019/09/10
|
ELITE LABS INC |
活性成分:ACETAMINOPHEN; CODEINE PHOSPHATE 剂型/给药途径:TABLET;ORAL 规格:300MG;30MG 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 |
|---|
| 085868 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;30MG |
Discontinued |
No |
No |
AA |
Approved Prior to Jan 1, 1982
|
SUN PHARM INDS LTD |
| 088629 |
003 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;30MG |
Discontinued |
No |
No |
AA |
1985/03/06
|
NOSTRUM LABS INC |
| 089805 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;30MG |
Prescription |
No |
No |
AA |
1988/09/30
|
STRIDES PHARMA |
| 040419 |
002 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;30MG |
Prescription |
No |
Yes |
AA |
2001/05/31
|
SPECGX LLC |
| 040779 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;30MG |
Prescription |
No |
No |
AA |
2008/05/29
|
AMNEAL PHARMS NY |
| 202800 |
002 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;30MG |
Prescription |
No |
No |
AA |
2013/04/15
|
AUROLIFE PHARMA LLC |
| 211610 |
002 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;30MG |
Prescription |
No |
No |
AA |
2019/06/27
|
WES PHARMA INC |
| 212418 |
002 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;30MG |
Prescription |
No |
No |
AA |
2019/09/10
|
ELITE LABS INC |
活性成分:ACETAMINOPHEN; CODEINE PHOSPHATE 剂型/给药途径:TABLET;ORAL 规格:300MG;60MG 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 |
|---|
| 087083 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;60MG |
Prescription |
No |
No |
AA |
Approved Prior to Jan 1, 1982
|
SUN PHARM INDS LTD |
| 088629 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;60MG |
Discontinued |
Yes |
No |
AA |
1985/03/06
|
NOSTRUM LABS INC |
| 089828 |
001 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;60MG |
Prescription |
No |
No |
AA |
1988/09/30
|
STRIDES PHARMA |
| 040419 |
003 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;60MG |
Prescription |
No |
Yes |
AA |
2001/05/31
|
SPECGX LLC |
| 202800 |
003 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;60MG |
Prescription |
No |
No |
AA |
2013/04/15
|
AUROLIFE PHARMA LLC |
| 211610 |
003 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;60MG |
Prescription |
No |
No |
AA |
2019/06/27
|
WES PHARMA INC |
| 212418 |
003 |
ANDA |
ACETAMINOPHEN AND CODEINE PHOSPHATE |
ACETAMINOPHEN; CODEINE PHOSPHATE |
TABLET;ORAL |
300MG;60MG |
Prescription |
No |
No |
AA |
2019/09/10
|
ELITE LABS INC |