| 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 |
PREGABALIN |
219593 |
8 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
300MG |
No |
No |
2026-04-30 |
2026-04-30 |
UNICHEM |
Prescription |
| 2 |
METHOTREXATE SODIUM |
219865 |
1 |
ANDA |
METHOTREXATE SODIUM |
INJECTABLE;INJECTION |
EQ 50MG BASE/2ML (EQ 25MG BASE/ML) |
No |
No |
2026-04-30 |
2026-04-30 |
HETERO LABS LTD VI |
Prescription |
| 3 |
FLUORESCEIN SODIUM |
220046 |
1 |
ANDA |
FLUORESCEIN SODIUM |
INJECTABLE;INTRAVENOUS |
EQ 500MG BASE/5ML (EQ 100MG BASE/ML) |
No |
No |
2026-04-30 |
2026-04-30 |
BPI LABS |
Prescription |
| 4 |
FLUVOXAMINE MALEATE |
220328 |
1 |
ANDA |
FLUVOXAMINE MALEATE |
CAPSULE, EXTENDED RELEASE;ORAL |
100MG |
No |
No |
2026-04-30 |
2026-04-30 |
APPCO |
Prescription |
| 5 |
FLUVOXAMINE MALEATE |
220328 |
2 |
ANDA |
FLUVOXAMINE MALEATE |
CAPSULE, EXTENDED RELEASE;ORAL |
150MG |
No |
No |
2026-04-30 |
2026-04-30 |
APPCO |
Prescription |
| 6 |
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
202426 |
1 |
ANDA |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
500MG;EQ 50MG BASE |
No |
No |
2026-04-30 |
2026-04-30 |
APOTEX |
Prescription |
| 7 |
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
202426 |
2 |
ANDA |
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE |
TABLET;ORAL |
1GM;EQ 50MG BASE |
No |
No |
2026-04-30 |
2026-04-30 |
APOTEX |
Prescription |
| 8 |
GLYCEROL PHENYLBUTYRATE |
207694 |
1 |
ANDA |
GLYCEROL PHENYLBUTYRATE |
LIQUID;ORAL |
1.1GM/ML |
No |
No |
2026-04-30 |
2026-04-30 |
LUPIN |
Prescription |
| 9 |
PREGABALIN |
219593 |
1 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
25MG |
No |
No |
2026-04-30 |
2026-04-30 |
UNICHEM |
Prescription |
| 10 |
PREGABALIN |
219593 |
2 |
ANDA |
PREGABALIN |
CAPSULE;ORAL |
50MG |
No |
No |
2026-04-30 |
2026-04-30 |
UNICHEM |
Prescription |