| DAPTOMYCIN |
213786 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
No
|
No
|
2021/06/29
|
2021/06/29
|
MEITHEAL |
Prescription |
| DAPTOMYCIN |
215316 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
Yes
|
2021/08/24
|
2021/08/24
|
QILU PHARM HAINAN |
Prescription |
| DAPTOMYCIN |
213171 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2021/09/02
|
2021/09/02
|
EUGIA PHARMA |
Prescription |
| DAPTOMYCIN |
215215 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2021/11/26
|
2021/11/26
|
HANGZHOU ZHONGMEI |
Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE |
213645 |
002 |
NDA |
DAPTOMYCIN |
SOLUTION;INTRAVENOUS |
350MG/50ML (7MG/ML) |
Yes
|
Yes
|
2022/01/25
|
2023/02/27
|
BAXTER HLTHCARE CORP |
Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE |
213645 |
003 |
NDA |
DAPTOMYCIN |
SOLUTION;INTRAVENOUS |
500MG/50ML (10MG/ML) |
Yes
|
Yes
|
2022/01/25
|
2023/02/27
|
BAXTER HLTHCARE CORP |
Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE |
213645 |
004 |
NDA |
DAPTOMYCIN |
SOLUTION;INTRAVENOUS |
700MG/100ML (7MG/ML) |
Yes
|
Yes
|
2022/01/25
|
2023/02/27
|
BAXTER HLTHCARE CORP |
Prescription |
| DAPTOMYCIN IN 0.9% SODIUM CHLORIDE |
213645 |
005 |
NDA |
DAPTOMYCIN |
SOLUTION;INTRAVENOUS |
1GM/100ML (10MG/ML) |
Yes
|
Yes
|
2022/01/25
|
2023/02/27
|
BAXTER HLTHCARE CORP |
Prescription |
| DAPTOMYCIN |
215890 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2022/08/18
|
2022/08/18
|
HAINAN POLY PHARM |
Prescription |
| DAPTOMYCIN |
216413 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2022/09/23
|
2022/09/23
|
ASPIRO |
Prescription |
| DAPTOMYCIN |
216445 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
No
|
No
|
2022/12/23
|
2022/12/23
|
ASPIRO |
Prescription |
| DAPTOMYCIN |
217415 |
001 |
NDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
350MG/VIAL |
Yes
|
Yes
|
2023/01/30
|
2023/01/30
|
XELLIA PHARMS APS |
Prescription |
| DAPTOMYCIN |
217415 |
002 |
NDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
Yes
|
Yes
|
2023/01/30
|
2023/01/30
|
XELLIA PHARMS APS |
Prescription |
| DAPTOMYCIN |
213966 |
001 |
ANDA |
DAPTOMYCIN |
POWDER;INTRAVENOUS |
500MG/VIAL |
No
|
No
|
2023/08/07
|
2023/08/07
|
MYLAN |
Prescription |