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 |
|---|
| 2014/11/17 |
SUPPL-1（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2008/02/28 |
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:IMIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:50MG 治疗等效代码:AB
| 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 |
|---|
| 084937 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 088276 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1983/10/21
|
STRIDES PHARMA |
| 087846 |
001 |
ANDA |
TOFRANIL |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Discontinued |
Yes |
No |
AB |
1984/05/22
|
SPECGX LLC |
| 081050 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
1990/06/05
|
SUN PHARM INDUSTRIES |
| 040751 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
No |
AB |
2008/02/28
|
OXFORD PHARMS |
| 040903 |
003 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
50MG |
Prescription |
No |
Yes |
AB |
2012/10/24
|
LEADING |
活性成分:IMIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:25MG 治疗等效代码:AB
| 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 |
|---|
| 083745 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 088262 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1983/10/21
|
STRIDES PHARMA |
| 087846 |
003 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Discontinued |
Yes |
No |
AB |
1984/05/22
|
SPECGX LLC |
| 081049 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
1990/06/05
|
SUN PHARM INDUSTRIES |
| 040751 |
002 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2008/02/28
|
OXFORD PHARMS |
| 040903 |
002 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
25MG |
Prescription |
No |
No |
AB |
2012/10/24
|
LEADING |
活性成分:IMIPRAMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AB
| 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 |
|---|
| 084936 |
002 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 088292 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
1983/10/21
|
STRIDES PHARMA |
| 087846 |
002 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Discontinued |
Yes |
No |
AB |
1984/05/22
|
SPECGX LLC |
| 081048 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Discontinued |
No |
No |
AB |
1990/06/05
|
SUN PHARM INDUSTRIES |
| 040751 |
003 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2008/02/28
|
OXFORD PHARMS |
| 040903 |
001 |
ANDA |
IMIPRAMINE HYDROCHLORIDE |
IMIPRAMINE HYDROCHLORIDE |
TABLET;ORAL |
10MG |
Prescription |
No |
No |
AB |
2012/10/24
|
LEADING |
