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 |
|---|
| 2023/12/15 |
SUPPL-90（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/06/28 |
SUPPL-89（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2018/06/19 |
SUPPL-88（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/08/29 |
SUPPL-87（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2017/01/13 |
SUPPL-86（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2014/02/19 |
SUPPL-83（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2009/08/27 |
SUPPL-78（补充） |
Approval |
Labeling |
|
|
|
| 2008/12/19 |
SUPPL-74（补充） |
Approval |
Labeling |
|
|
|
| 2005/10/06 |
SUPPL-60（补充） |
Approval |
Labeling |
|
|
|
| 2005/05/02 |
SUPPL-54（补充） |
Approval |
Labeling |
|
|
|
| 2003/06/06 |
SUPPL-47（补充） |
Approval |
Labeling |
|
|
|
| 2001/10/03 |
SUPPL-46（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2001/10/03 |
SUPPL-45（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/10/02 |
SUPPL-44（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/12/01 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/12/01 |
SUPPL-39（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1997/09/15 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/10/21 |
SUPPL-36（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/06/18 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/05/30 |
SUPPL-27（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/05/30 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/05/07 |
SUPPL-33（补充） |
Approval |
Labeling |
|
|
|
| 1996/05/07 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/05/07 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/05/07 |
SUPPL-29（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/05/07 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/10/23 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/04/29 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/08/03 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/04/05 |
SUPPL-22（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/09/28 |
SUPPL-21（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/08/24 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1989/11/03 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1989/06/21 |
SUPPL-16（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/06/21 |
SUPPL-15（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1989/06/21 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/12/15 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/12/15 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/10/13 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/03/10 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/03/10 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/02/18 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/02/18 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/08/14 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/10/31 |
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:CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE 剂型/给药途径:SYRUP;ORAL 规格:10MG/5ML;6.25MG/5ML 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 |
|---|
| 088763 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
10MG/5ML;6.25MG/5ML |
Discontinued |
Yes |
No |
AA |
1984/10/31
|
ACTAVIS MID ATLANTIC |
| 088875 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
10MG/5ML;6.25MG/5ML |
Prescription |
No |
No |
AA |
1984/12/17
|
WOCKHARDT BIO AG |
| 040151 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
10MG/5ML;6.25MG/5ML |
Discontinued |
No |
No |
AA |
1997/08/26
|
HIKMA |
| 040650 |
001 |
ANDA |
PROMETHAZINE WITH CODEINE |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
10MG/5ML;6.25MG/5ML |
Prescription |
No |
No |
AA |
2006/01/31
|
PHARM ASSOC |
| 090180 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
10MG/5ML;6.25MG/5ML |
Prescription |
No |
No |
AA |
2010/03/17
|
NOSTRUM LABS INC |
| 200386 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
10MG/5ML;6.25MG/5ML |
Prescription |
No |
Yes |
AA |
2012/06/29
|
TRIS PHARMA INC |
| 200894 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
10MG/5ML;6.25MG/5ML |
Prescription |
No |
No |
AA |
2013/04/24
|
AMNEAL PHARMS |
| 214238 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE |
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
10MG/5ML;6.25MG/5ML |
Prescription |
No |
No |
AA |
2020/10/08
|
QUAGEN |