| 序号 |
商品名 |
申请号 |
产品号 |
申请类型 |
活性成分 |
剂型 |
规格 |
参比药物 |
参比标准 |
申请号批准日期 |
产品号批准日期 |
申请人 |
市场状态 |
| 1 |
PANTOPRAZOLE SODIUM |
217458 |
1 |
ANDA |
PANTOPRAZOLE SODIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
|
|
2025-03-31 |
2025-03-31 |
CIPLA |
Prescription |
| 2 |
PANTOPRAZOLE SODIUM |
217923 |
1 |
ANDA |
PANTOPRAZOLE SODIUM |
FOR SUSPENSION, DELAYED RELEASE;ORAL |
EQ 40MG BASE |
|
|
2025-03-31 |
2025-03-31 |
AUROBINDO PHARMA LTD |
Prescription |
| 3 |
PANTOPRAZOLE SODIUM |
219230 |
1 |
ANDA |
PANTOPRAZOLE SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 40MG BASE/VIAL |
|
|
2025-03-31 |
2025-03-31 |
ALEMBIC |
Prescription |
| 4 |
QFITLIA |
219019 |
1 |
NDA |
FITUSIRAN SODIUM |
SOLUTION;SUBCUTANEOUS |
EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) |
|
|
2025-03-28 |
2025-03-28 |
GENZYME CORP |
Prescription |
| 5 |
QFITLIA |
219019 |
2 |
NDA |
FITUSIRAN SODIUM |
SOLUTION;SUBCUTANEOUS |
EQ 50MG BASE/0.5ML (EQ 50MG BASE/0.5ML) |
|
|
2025-03-28 |
2025-03-28 |
GENZYME CORP |
Prescription |
| 6 |
DOXYCYCLINE |
210381 |
1 |
ANDA |
DOXYCYCLINE |
CAPSULE;ORAL |
40MG |
|
|
2025-03-27 |
2025-03-27 |
MACLEODS PHARMS LTD |
Prescription |
| 7 |
TECHNETIUM TC-99M PENTETATE KIT |
215146 |
1 |
ANDA |
TECHNETIUM TC-99M PENTETATE KIT |
INJECTABLE;INJECTION |
N/A |
|
|
2025-03-26 |
2025-03-26 |
CURIUM |
Prescription |
| 8 |
VYKAT XR |
216665 |
1 |
NDA |
DIAZOXIDE CHOLINE |
TABLET, EXTENDED RELEASE;ORAL |
25MG |
|
|
2025-03-26 |
2025-03-26 |
SOLENO THERAP |
Prescription |
| 9 |
VYKAT XR |
216665 |
2 |
NDA |
DIAZOXIDE CHOLINE |
TABLET, EXTENDED RELEASE;ORAL |
75MG |
|
|
2025-03-26 |
2025-03-26 |
SOLENO THERAP |
Prescription |
| 10 |
VYKAT XR |
216665 |
3 |
NDA |
DIAZOXIDE CHOLINE |
TABLET, EXTENDED RELEASE;ORAL |
150MG |
|
|
2025-03-26 |
2025-03-26 |
SOLENO THERAP |
Prescription |