美国FDA药品数据库（U.S. FDA Drugs Database）
符合检索条件的记录共 120 条
共 6 页，当前第 6 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 |
| VANCOMYCIN HYDROCHLORIDE |
214913 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
FOR SOLUTION;ORAL |
EQ 25MG BASE/ML |
No
|
No
|
2022/11/14
|
2022/11/14
|
ALKEM LABS LTD |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
214913 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
FOR SOLUTION;ORAL |
EQ 50MG BASE/ML |
No
|
No
|
2022/11/14
|
2022/11/14
|
ALKEM LABS LTD |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
210274 |
001 |
NDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS, ORAL |
EQ 500MG BASE/VIAL |
Yes
|
Yes
|
2023/01/20
|
2023/01/20
|
ZHEJIANG NOVUS PHARM |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
210274 |
002 |
NDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS, ORAL |
EQ 1GM BASE/VIAL |
Yes
|
Yes
|
2023/01/20
|
2023/01/20
|
ZHEJIANG NOVUS PHARM |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
210274 |
003 |
NDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS, ORAL |
EQ 5GM BASE/VIAL |
Yes
|
Yes
|
2023/01/20
|
2023/01/20
|
ZHEJIANG NOVUS PHARM |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
210274 |
004 |
NDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS, ORAL |
EQ 10GM BASE/VIAL |
Yes
|
Yes
|
2023/01/20
|
2023/01/20
|
ZHEJIANG NOVUS PHARM |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
210274 |
005 |
NDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS, ORAL |
EQ 750MG BASE/VIAL |
Yes
|
Yes
|
2023/01/20
|
2025/08/01
|
ZHEJIANG NOVUS PHARM |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
210274 |
006 |
NDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS, ORAL |
EQ 1.25GM BASE/VIAL |
Yes
|
Yes
|
2023/01/20
|
2025/08/01
|
ZHEJIANG NOVUS PHARM |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
210274 |
007 |
NDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS, ORAL |
EQ 1.5MG BASE/VIAL |
Yes
|
Yes
|
2023/01/20
|
2025/08/01
|
ZHEJIANG NOVUS PHARM |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
215338 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
FOR SOLUTION;ORAL |
EQ 250MG BASE/5ML |
No
|
No
|
2023/06/23
|
2023/06/23
|
AMNEAL |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
217489 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 1.25GM BASE/VIAL |
No
|
No
|
2023/06/29
|
2023/06/29
|
HIKMA |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
217489 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 1.5GM BASE/VIAL |
No
|
No
|
2023/06/29
|
2023/06/29
|
HIKMA |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
217401 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 1.25GM BASE/VIAL |
No
|
No
|
2023/08/04
|
2023/08/04
|
EUGIA PHARMA |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
217401 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 1.5GM BASE/VIAL |
No
|
No
|
2023/08/04
|
2023/08/04
|
EUGIA PHARMA |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
218140 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 750MG BASE/VIAL |
No
|
No
|
2025/03/21
|
2025/03/21
|
GLAND |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
218140 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 1.25GM BASE/VIAL |
No
|
No
|
2025/03/21
|
2025/03/21
|
GLAND |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
218140 |
003 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 1.5GM BASE/VIAL |
No
|
No
|
2025/03/21
|
2025/03/21
|
GLAND |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
215324 |
001 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 750MG BASE/VIAL |
No
|
No
|
2025/10/02
|
2025/10/02
|
STERISCIENCE |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
215324 |
002 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 1.25GM BASE/VIAL |
No
|
No
|
2025/10/02
|
2025/10/02
|
STERISCIENCE |
Prescription |
| VANCOMYCIN HYDROCHLORIDE |
215324 |
003 |
ANDA |
VANCOMYCIN HYDROCHLORIDE |
POWDER;INTRAVENOUS |
EQ 1.5GM BASE/VIAL |
No
|
No
|
2025/10/02
|
2025/10/02
|
STERISCIENCE |
Prescription |