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 |
|---|
| 2006/04/04 |
SUPPL-36（补充） |
Approval |
Labeling |
|
|
|
| 2005/12/21 |
SUPPL-35（补充） |
Approval |
Labeling |
|
|
|
| 2000/02/17 |
SUPPL-32（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/02/17 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/02/17 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/02/17 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 2000/02/17 |
SUPPL-28（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/06/05 |
SUPPL-22（补充） |
Approval |
Labeling |
|
|
|
| 1994/08/10 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 1992/02/11 |
SUPPL-20（补充） |
Approval |
Labeling |
|
|
|
| 1991/01/18 |
SUPPL-19（补充） |
Approval |
Labeling |
|
|
|
| 1990/01/19 |
SUPPL-18（补充） |
Approval |
Labeling |
|
|
|
| 1989/03/15 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1987/03/16 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/02/20 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/02/20 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/02/20 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/02/20 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/02/20 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/02/20 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/01/16 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/11/15 |
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:PROMETHAZINE HYDROCHLORIDE 剂型/给药途径:SYRUP;ORAL 规格: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 |
|---|
| 087953 |
001 |
ANDA |
PROMETHAZINE PLAIN |
PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
6.25MG/5ML |
Prescription |
Yes |
Yes |
AA |
1982/11/15
|
WOCKHARDT BIO AG |
| 040026 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
6.25MG/5ML |
Prescription |
No |
No |
AA |
1998/09/25
|
CHARTWELL RX |
| 040643 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
6.25MG/5ML |
Discontinued |
No |
No |
AA |
2006/04/26
|
PHARM ASSOC |
| 040718 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
6.25MG/5ML |
Prescription |
No |
No |
AA |
2007/04/04
|
TARO |
| 040891 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
6.25MG/5ML |
Prescription |
No |
No |
AA |
2009/03/13
|
NOSTRUM LABS INC |
| 040882 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
6.25MG/5ML |
Discontinued |
No |
No |
AA |
2009/12/30
|
AMNEAL PHARMS |
| 091675 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
6.25MG/5ML |
Prescription |
No |
No |
AA |
2012/06/28
|
TRIS PHARMA INC |
| 213890 |
001 |
ANDA |
PROMETHAZINE HYDROCHLORIDE |
PROMETHAZINE HYDROCHLORIDE |
SYRUP;ORAL |
6.25MG/5ML |
Prescription |
No |
No |
AA |
2021/07/12
|
QUAGEN |