美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 20 条
共 1 页，当前第 1 页
| 商品名 |
申请号 |
产品号 |
申请类型 |
活性成分 |
剂型/给药途径 |
规格/剂量 |
RLD |
RS |
申请号原始批准/暂定批准日期 |
产品号批准日期 |
申请人 |
市场状态 |
| ZALEPLON |
077237 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
HIKMA |
Prescription |
| ZALEPLON |
077237 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
HIKMA |
Prescription |
| ZALEPLON |
077238 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
NATCO PHARMA |
Discontinued |
| ZALEPLON |
077238 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
NATCO PHARMA |
Discontinued |
| ZALEPLON |
077239 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
TEVA PHARMS |
Discontinued |
| ZALEPLON |
077239 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
TEVA PHARMS |
Discontinued |
| ZALEPLON |
078095 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
UPSHER SMITH LABS |
Discontinued |
| ZALEPLON |
078095 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
UPSHER SMITH LABS |
Discontinued |
| ZALEPLON |
078706 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
UPSHER SMITH LABS |
Discontinued |
| ZALEPLON |
078706 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
UPSHER SMITH LABS |
Discontinued |
| ZALEPLON |
078829 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
AUROBINDO PHARMA |
Prescription |
| ZALEPLON |
078829 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
AUROBINDO PHARMA |
Prescription |
| ZALEPLON |
078989 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
UNICHEM |
Prescription |
| ZALEPLON |
078989 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2008/06/06
|
2008/06/06
|
UNICHEM |
Prescription |
| ZALEPLON |
077505 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2008/06/20
|
2008/06/20
|
CHARTWELL MOLECULAR |
Prescription |
| ZALEPLON |
077505 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2008/06/20
|
2008/06/20
|
CHARTWELL MOLECULAR |
Prescription |
| ZALEPLON |
078147 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2008/11/25
|
2008/11/25
|
HIKMA PHARMS |
Discontinued |
| ZALEPLON |
078147 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2008/11/25
|
2008/11/25
|
HIKMA PHARMS |
Discontinued |
| ZALEPLON |
090374 |
001 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
5MG |
No
|
No
|
2009/09/17
|
2009/09/17
|
ORBION PHARMS |
Prescription |
| ZALEPLON |
090374 |
002 |
ANDA |
ZALEPLON |
CAPSULE;ORAL |
10MG |
No
|
No
|
2009/09/17
|
2009/09/17
|
ORBION PHARMS |
Prescription |