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
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 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 |
|---|
| 1981/06/12 |
ORIG-1（原始申请） |
Approval |
|
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 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-39（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2012/12/06 |
SUPPL-36（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2012/12/06 |
SUPPL-35（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2002/10/15 |
SUPPL-25（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 2000/02/02 |
SUPPL-24（补充） |
Approval |
Manufacturing (CMC)-Facility |
|
|
|
| 1998/09/24 |
SUPPL-23（补充） |
Approval |
Labeling |
|
|
|
| 1998/08/10 |
SUPPL-22（补充） |
Approval |
Labeling |
|
|
|
| 1998/04/30 |
SUPPL-21（补充） |
Approval |
Labeling |
|
|
|
| 1996/06/19 |
SUPPL-17（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1996/04/12 |
SUPPL-20（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1995/11/21 |
SUPPL-18（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1994/12/19 |
SUPPL-14（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1993/01/22 |
SUPPL-16（补充） |
Approval |
Labeling |
|
|
|
| 1989/10/03 |
SUPPL-13（补充） |
Approval |
Labeling |
|
|
|
| 1988/04/12 |
SUPPL-12（补充） |
Approval |
Labeling |
|
|
|
| 1985/09/19 |
SUPPL-8（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1985/01/30 |
SUPPL-9（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/11/10 |
SUPPL-6（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/09/02 |
SUPPL-5（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1983/09/02 |
SUPPL-4（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/02/03 |
SUPPL-2（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
| 1982/02/03 |
SUPPL-1（补充） |
Approval |
Manufacturing (CMC) |
|
|
|
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:CAPSULE;ORAL; 规格:30MG; 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 |
|---|
| 087190 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Prescription |
Yes |
Yes |
AA |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 087022 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Discontinued |
No |
No |
AA |
1983/02/03
|
LANNETT |
| 086945 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Prescription |
Yes |
Yes |
AA |
1983/07/20
|
SANDOZ |
| 040525 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Discontinued |
No |
No |
AA |
2003/10/23
|
SUN PHARM INDUSTRIES |
| 040875 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AA |
2008/03/21
|
KVK TECH |
| 040886 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AA |
2008/03/31
|
KVK TECH |
| 202248 |
002 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AA |
2012/09/28
|
ELITE LABS |
| 202858 |
002 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Discontinued |
No |
No |
AA |
2014/02/14
|
INVAGEN PHARMS |
| 204414 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Discontinued |
No |
No |
AA |
2014/05/05
|
INVAGEN PHARMS |
| 205019 |
002 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AA |
2014/12/05
|
NUVO PHARM |
| 204318 |
002 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
30MG |
Prescription |
No |
No |
AA |
2016/11/09
|
AUROLIFE PHARMA LLC |
>>>活性成分:PHENTERMINE HYDROCHLORIDE; 剂型/给药途径:CAPSULE;ORAL; 规格:15MG; 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 |
|---|
| 087190 |
002 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
15MG |
Prescription |
Yes |
Yes |
AA |
Approved Prior to Jan 1, 1982
|
SANDOZ |
| 040886 |
002 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AA |
2008/03/31
|
KVK TECH |
| 087022 |
002 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
15MG |
Discontinued |
No |
No |
AA |
2012/01/20
|
LANNETT |
| 202248 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AA |
2012/09/28
|
ELITE LABS |
| 202858 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
15MG |
Discontinued |
No |
No |
AA |
2014/02/14
|
INVAGEN PHARMS |
| 205019 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AA |
2014/12/05
|
NUVO PHARM |
| 204318 |
001 |
ANDA |
PHENTERMINE HYDROCHLORIDE |
PHENTERMINE HYDROCHLORIDE |
CAPSULE;ORAL |
15MG |
Prescription |
No |
No |
AA |
2016/11/09
|
AUROLIFE PHARMA LLC |