| 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 |
PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID |
207498 |
1 |
ANDA |
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE |
FOR SOLUTION;ORAL |
4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM |
No |
No |
2024-06-28 |
2024-06-28 |
TARO |
Prescription |
| 2 |
RASAGILINE MESYLATE |
208866 |
1 |
ANDA |
RASAGILINE MESYLATE |
TABLET;ORAL |
EQ 0.5MG BASE |
No |
No |
2024-06-28 |
2024-06-28 |
MACLEODS PHARMS LTD |
Prescription |
| 3 |
RASAGILINE MESYLATE |
208866 |
2 |
ANDA |
RASAGILINE MESYLATE |
TABLET;ORAL |
EQ 1MG BASE |
No |
No |
2024-06-28 |
2024-06-28 |
MACLEODS PHARMS LTD |
Prescription |
| 4 |
PEMETREXED |
210661 |
1 |
NDA |
PEMETREXED |
INJECTABLE;INJECTION |
100MG |
No |
No |
2024-06-28 |
2024-06-28 |
APOTEX INC |
None (Tentative Approval) |
| 5 |
PEMETREXED |
210661 |
1 |
NDA |
PEMETREXED |
INJECTABLE;INJECTION |
100MG |
No |
No |
2024-06-28 |
2024-06-28 |
APOTEX INC |
None (Tentative Approval) |
| 6 |
PEMETREXED |
210661 |
2 |
NDA |
PEMETREXED |
INJECTABLE;INJECTION |
500MG |
No |
No |
2024-06-28 |
2024-06-28 |
APOTEX INC |
None (Tentative Approval) |
| 7 |
PEMETREXED |
210661 |
2 |
NDA |
PEMETREXED |
INJECTABLE;INJECTION |
500MG |
No |
No |
2024-06-28 |
2024-06-28 |
APOTEX INC |
None (Tentative Approval) |
| 8 |
REMIFENTANIL HYDROCHLORIDE |
215635 |
1 |
ANDA |
REMIFENTANIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 1MG BASE/VIAL |
No |
No |
2024-06-28 |
2024-06-28 |
NIVAGEN PHARMS INC |
Prescription |
| 9 |
REMIFENTANIL HYDROCHLORIDE |
215635 |
2 |
ANDA |
REMIFENTANIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 2MG BASE/VIAL |
No |
No |
2024-06-28 |
2024-06-28 |
NIVAGEN PHARMS INC |
Prescription |
| 10 |
REMIFENTANIL HYDROCHLORIDE |
215635 |
3 |
ANDA |
REMIFENTANIL HYDROCHLORIDE |
INJECTABLE;INJECTION |
EQ 5MG BASE/VIAL |
No |
No |
2024-06-28 |
2024-06-28 |
NIVAGEN PHARMS INC |
Prescription |