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 |
|---|
| 2013/04/26 |
SUPPL-42（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2013/01/28 |
SUPPL-40（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2010/11/01 |
SUPPL-29（补充） |
Approval |
Labeling |
|
|
|
| 2001/10/11 |
SUPPL-14（补充） |
Approval |
Labeling |
|
|
|
| 2001/06/08 |
SUPPL-13（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/07/07 |
SUPPL-12（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/05/11 |
SUPPL-11（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1990/04/04 |
SUPPL-10（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1988/03/25 |
SUPPL-8（补充） |
Approval |
Labeling |
|
|
|
| 1986/07/22 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/06/04 |
SUPPL-7（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1986/02/21 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/05/22 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/03/15 |
SUPPL-3（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/03/15 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1984/05/01 |
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:HYDRALAZINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 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 |
|---|
| 086242 |
003 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AA |
Approved Prior to Jan 1, 1982
|
HERITAGE PHARMS |
| 086961 |
002 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AA |
Approved Prior to Jan 1, 1982
|
STRIDES PHARMA |
| 088467 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
Yes |
Yes |
AA |
1984/05/01
|
PLIVA |
| 040901 |
002 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AA |
2008/09/12
|
HETERO LABS LTD III |
| 090255 |
002 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Discontinued |
No |
No |
AA |
2008/12/15
|
INVAGEN PHARMS |
| 090527 |
002 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AA |
2009/05/27
|
GLENMARK PHARMS LTD |
| 040858 |
002 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AA |
2010/02/26
|
HERITAGE PHARMS INC |
| 200737 |
002 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AA |
2012/12/07
|
ALKEM LABS LTD |
| 200770 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AA |
2013/05/03
|
STRIDES PHARMA |
| 203845 |
001 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AA |
2014/09/18
|
CADILA PHARMS LTD |
| 205236 |
002 |
ANDA |
HYDRALAZINE HYDROCHLORIDE |
HYDRALAZINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AA |
2017/05/26
|
SCIEGEN PHARMS INC |