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 |
|---|
| 2017/05/31 |
SUPPL-16（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/12/05 |
SUPPL-10（补充） |
Approval |
Labeling |
STANDARD
|
|
|
| 2012/04/27 |
SUPPL-9（补充） |
Approval |
Labeling |
|
|
|
| 2011/08/22 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2005/04/15 |
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:PHENTERMINE HYDROCHLORIDE 剂型/给药途径:TABLET;ORAL 规格:37.5MG 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 |
|---|
| 085128 |
001 |
ANDA |
ADIPEX-P |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Prescription |
Yes |
Yes |
AA |
Approved Prior to Jan 1, 1982
|
TEVA |
| 040190 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Prescription |
No |
No |
AA |
1997/05/30
|
ELITE LABS INC |
| 040377 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Prescription |
No |
No |
AA |
2002/01/04
|
PRINSTON INC |
| 040526 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Prescription |
No |
No |
AA |
2003/10/23
|
SUN PHARM INDUSTRIES |
| 040555 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Discontinued |
No |
No |
AA |
2005/04/15
|
LANNETT |
| 040876 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Prescription |
No |
No |
AA |
2008/03/31
|
KVK TECH |
| 200272 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Prescription |
No |
No |
AA |
2011/01/31
|
ELITE LABS |
| 202942 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Discontinued |
No |
No |
AA |
2014/02/05
|
INVAGEN PHARMS |
| 203068 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Prescription |
No |
No |
AA |
2014/08/06
|
AUROBINDO PHARMA LTD |
| 205008 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Prescription |
No |
No |
AA |
2014/09/25
|
NUVO PHARM |
| 206342 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
TABLET;ORAL |
37.5MG |
Prescription |
No |
No |
AA |
2016/11/18
|
MERRO PHARM USA |