| 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 |
LORATADINE |
215127 |
1 |
ANDA |
LORATADINE |
CAPSULE;ORAL |
10MG |
No |
No |
2025-02-28 |
2025-02-28 |
CATALENT PHARMA |
Over-the-counter |
| 2 |
EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE |
218475 |
1 |
NDA |
EPINEPHRINE BITARTRATE |
SOLUTION;INTRAVENOUS |
EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) |
Yes |
Yes |
2025-02-28 |
2025-02-28 |
BAXTER HLTHCARE CORP |
Prescription |
| 3 |
FEXOFENADINE HYDROCHLORIDE |
219032 |
1 |
ANDA |
FEXOFENADINE HYDROCHLORIDE |
TABLET;ORAL |
60MG |
No |
No |
2025-02-28 |
2025-02-28 |
CONTRACT PHARMACAL |
Over-the-counter |
| 4 |
FEXOFENADINE HYDROCHLORIDE |
219032 |
2 |
ANDA |
FEXOFENADINE HYDROCHLORIDE |
TABLET;ORAL |
180MG |
No |
No |
2025-02-28 |
2025-02-28 |
CONTRACT PHARMACAL |
Over-the-counter |
| 5 |
OLOPATADINE HYDROCHLORIDE |
219557 |
1 |
ANDA |
OLOPATADINE HYDROCHLORIDE |
SOLUTION/DROPS;OPHTHALMIC |
EQ 0.2% BASE |
No |
No |
2025-02-28 |
2025-02-28 |
GLENMARK PHARMS INC |
Over-the-counter |
| 6 |
APIXABAN |
210067 |
1 |
ANDA |
APIXABAN |
TABLET;ORAL |
2.5MG |
No |
No |
2025-02-27 |
2025-02-27 |
MACLEODS PHARMS LTD |
Prescription |
| 7 |
APIXABAN |
210067 |
2 |
ANDA |
APIXABAN |
TABLET;ORAL |
5MG |
No |
No |
2025-02-27 |
2025-02-27 |
MACLEODS PHARMS LTD |
Prescription |
| 8 |
SEVELAMER CARBONATE |
215909 |
1 |
ANDA |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
800MG/PACKET |
No |
No |
2025-02-27 |
2025-02-27 |
TORRENT |
Prescription |
| 9 |
SEVELAMER CARBONATE |
215909 |
2 |
ANDA |
SEVELAMER CARBONATE |
FOR SUSPENSION;ORAL |
2.4GM/PACKET |
No |
No |
2025-02-27 |
2025-02-27 |
TORRENT |
Prescription |
| 10 |
TRETINOIN |
218245 |
1 |
ANDA |
TRETINOIN |
GEL;TOPICAL |
0.00025 |
No |
No |
2025-02-27 |
2025-02-27 |
AUROBINDO PHARMA LTD |
Prescription |