| 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 |
LEUPROLIDE ACETATE |
215826 |
1 |
ANDA |
LEUPROLIDE ACETATE |
SOLUTION;SUBCUTANEOUS |
14MG/2.8ML (1MG/0.2ML) |
No |
No |
2025-11-13 |
2025-11-13 |
ZYDUS PHARMS |
Prescription |
| 2 |
IOHEXOL |
217737 |
1 |
ANDA |
IOHEXOL |
SOLUTION;INJECTION, ORAL, RECTAL |
0.647 |
No |
No |
2025-11-13 |
2025-11-13 |
AMNEAL |
Prescription |
| 3 |
ATORVASTATIN CALCIUM |
220276 |
1 |
ANDA |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 10MG BASE |
No |
No |
2025-11-13 |
2025-11-13 |
TEVA PHARMS INC |
Prescription |
| 4 |
ATORVASTATIN CALCIUM |
220276 |
2 |
ANDA |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 20MG BASE |
No |
No |
2025-11-13 |
2025-11-13 |
TEVA PHARMS INC |
Prescription |
| 5 |
ATORVASTATIN CALCIUM |
220276 |
3 |
ANDA |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 40MG BASE |
No |
No |
2025-11-13 |
2025-11-13 |
TEVA PHARMS INC |
Prescription |
| 6 |
ATORVASTATIN CALCIUM |
220276 |
4 |
ANDA |
ATORVASTATIN CALCIUM |
TABLET;ORAL |
EQ 80MG BASE |
No |
No |
2025-11-13 |
2025-11-13 |
TEVA PHARMS INC |
Prescription |
| 7 |
LEUCOVORIN CALCIUM |
218200 |
1 |
ANDA |
LEUCOVORIN CALCIUM |
INJECTABLE;INJECTION |
EQ 350MG BASE/VIAL |
No |
No |
2025-11-12 |
2025-11-12 |
GLAND |
Prescription |
| 8 |
DIROXIMEL FUMARATE |
218596 |
1 |
ANDA |
DIROXIMEL FUMARATE |
CAPSULE, DELAYED RELEASE;ORAL |
231MG |
No |
No |
2025-11-12 |
2025-11-12 |
ZYDUS |
Prescription |
| 9 |
DEXLANSOPRAZOLE |
219115 |
1 |
ANDA |
DEXLANSOPRAZOLE |
CAPSULE, DELAYED RELEASE;ORAL |
30MG |
No |
No |
2025-11-12 |
2025-11-12 |
ALEMBIC |
Prescription |
| 10 |
DEXLANSOPRAZOLE |
219115 |
2 |
ANDA |
DEXLANSOPRAZOLE |
CAPSULE, DELAYED RELEASE;ORAL |
60MG |
No |
No |
2025-11-12 |
2025-11-12 |
ALEMBIC |
Prescription |