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 |
|---|
| 2002/11/05 |
SUPPL-41（补充） |
Approval |
Labeling |
|
|
|
| 1999/10/01 |
SUPPL-40（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/06/08 |
SUPPL-35（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1999/02/11 |
SUPPL-38（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/12/01 |
SUPPL-37（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1998/07/28 |
SUPPL-39（补充） |
Approval |
Labeling |
|
|
|
| 1998/01/29 |
SUPPL-36（补充） |
Approval |
Labeling |
|
|
|
| 1993/02/17 |
SUPPL-34（补充） |
Approval |
Labeling |
|
|
|
| 1992/10/30 |
SUPPL-33（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/07/23 |
SUPPL-31（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1992/01/27 |
SUPPL-30（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/11/05 |
SUPPL-32（补充） |
Approval |
Labeling |
|
|
|
| 1990/06/07 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 1988/11/23 |
SUPPL-28（补充） |
Approval |
Labeling |
|
|
|
| 1986/11/03 |
SUPPL-26（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/04/10 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/02/08 |
SUPPL-23（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1972/11/27 |
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:DIPHENHYDRAMINE HYDROCHLORIDE 剂型/给药途径:INJECTABLE;INJECTION 规格:50MG/ML 治疗等效代码:AP
| 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 |
|---|
| 080817 |
002 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE |
DIPHENHYDRAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
Yes |
Yes |
AP |
Approved Prior to Jan 1, 1982
|
WEST-WARD PHARMS INT |
| 040466 |
001 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE |
DIPHENHYDRAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2002/05/28
|
APP PHARMS |
| 040498 |
001 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE |
DIPHENHYDRAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
Yes |
AP |
2005/07/12
|
MYLAN INSTITUTIONAL |
| 091526 |
001 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE |
DIPHENHYDRAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2013/03/26
|
FRESENIUS KABI USA |
| 205723 |
001 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE |
DIPHENHYDRAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2018/08/22
|
MICRO LABS |
| 218448 |
001 |
ANDA |
DIPHENHYDRAMINE HYDROCHLORIDE |
DIPHENHYDRAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
50MG/ML |
Prescription |
No |
No |
AP |
2024/03/20
|
GLAND PHARMA LTD |