美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 34 条
共 2 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 |
| DAPTOMYCIN |
203797 |
001 |
NDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
No
|
No
|
2013/03/15
(TA)
|
--
|
HOSPIRA INC |
None (Tentative Approval) |
| DAPTOMYCIN |
202857 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2014/09/12
|
2014/09/12
|
HOSPIRA |
Discontinued |
| DAPTOMYCIN |
091039 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2016/03/25
|
2016/03/25
|
TEVA PHARMS USA |
Prescription |
| DAPTOMYCIN |
206005 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2016/06/15
|
2016/06/15
|
XELLIA PHARMS APS |
Prescription |
| DAPTOMYCIN |
208385 |
001 |
NDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
Yes
|
Yes
|
2017/09/12
|
2017/09/12
|
SAGENT PHARMS INC |
Prescription |
| DAPTOMYCIN |
209949 |
001 |
NDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
Yes
|
Yes
|
2017/10/20
|
2017/10/20
|
XELLIA PHARMS APS |
Prescription |
| DAPTOMYCIN |
206077 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2018/04/11
|
2018/04/11
|
FRESENIUS KABI USA |
Prescription |
| DAPTOMYCIN |
205037 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2018/06/05
|
2018/06/05
|
MYLAN LABS LTD |
Prescription |
| DAPTOMYCIN |
208375 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2019/05/01
|
2019/05/01
|
DR REDDYS |
Prescription |
| DAPTOMYCIN |
211961 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2019/06/24
|
2019/06/24
|
ACCORD HLTHCARE |
Prescription |
| DAPTOMYCIN |
212513 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2019/06/26
|
2019/06/26
|
BE PHARMS |
Prescription |
| DAPTOMYCIN |
212667 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
No
|
No
|
2019/07/12
|
2019/07/12
|
ACCORD HLTHCARE |
Prescription |
| DAPTOMYCIN |
212022 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2019/08/22
|
2019/08/22
|
HENGRUI PHARMA |
Prescription |
| DAPTOMYCIN |
207104 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2019/11/15
|
2019/11/15
|
SAGENT PHARMS INC |
Prescription |
| DAPTOMYCIN |
213425 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
No
|
No
|
2020/08/20
|
2020/08/20
|
BE PHARMS |
Prescription |
| DAPTOMYCIN |
211403 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
No
|
No
|
2020/08/31
|
2020/08/31
|
DR REDDYS |
Prescription |
| DAPTOMYCIN |
212250 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2021/04/21
|
2021/04/21
|
HISUN PHARM HANGZHOU |
Prescription |
| DAPTOMYCIN |
210282 |
001 |
NDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
Yes
|
Yes
|
2021/06/21
|
2021/06/21
|
HOSPIRA |
Prescription |
| DAPTOMYCIN |
210282 |
002 |
NDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Yes
|
Yes
|
2021/06/21
|
2021/06/21
|
HOSPIRA |
Prescription |
| DAPTOMYCIN |
213623 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2021/06/29
|
2021/06/29
|
MEITHEAL |
Prescription |