| 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 |
EPINEPHRINE |
217426 |
1 |
ANDA |
EPINEPHRINE |
SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS |
1MG/ML (1MG/ML) |
No |
No |
2026-07-31 |
2026-07-31 |
DEVA HLDING |
Prescription |
| 2 |
ATROPINE SULFATE |
219996 |
1 |
ANDA |
ATROPINE SULFATE |
SOLUTION/DROPS;OPHTHALMIC |
0.01 |
No |
No |
2026-07-31 |
2026-07-31 |
GLAND |
Prescription |
| 3 |
DOCOSANOL |
220017 |
1 |
ANDA |
DOCOSANOL |
CREAM;TOPICAL |
0.1 |
No |
No |
2026-07-31 |
2026-07-31 |
KLM LABS PVT |
Over-the-counter |
| 4 |
THIAMINE HYDROCHLORIDE |
220513 |
1 |
ANDA |
THIAMINE HYDROCHLORIDE |
INJECTABLE;INJECTION |
100MG/ML |
No |
No |
2026-07-31 |
2026-07-31 |
MANKIND PHARMA |
Prescription |
| 5 |
ASCORBIC ACID |
220172 |
1 |
ANDA |
ASCORBIC ACID |
SOLUTION;INTRAVENOUS |
25,000MG/50ML (500MG/ML) |
No |
No |
2026-07-30 |
2026-07-30 |
STIRA |
Prescription |
| 6 |
FEXOFENADINE HYDROCHLORIDE |
220413 |
1 |
ANDA |
FEXOFENADINE HYDROCHLORIDE |
TABLET;ORAL |
60MG |
No |
No |
2026-07-30 |
2026-07-30 |
DR REDDYS |
Over-the-counter |
| 7 |
FEXOFENADINE HYDROCHLORIDE |
220413 |
2 |
ANDA |
FEXOFENADINE HYDROCHLORIDE |
TABLET;ORAL |
180MG |
No |
No |
2026-07-30 |
2026-07-30 |
DR REDDYS |
Over-the-counter |
| 8 |
DOFETILIDE |
212496 |
1 |
ANDA |
DOFETILIDE |
CAPSULE;ORAL |
0.125MG |
No |
No |
2026-07-29 |
2026-07-29 |
ANDAS 5 HOLDING |
Prescription |
| 9 |
DOFETILIDE |
212496 |
2 |
ANDA |
DOFETILIDE |
CAPSULE;ORAL |
0.25MG |
No |
No |
2026-07-29 |
2026-07-29 |
ANDAS 5 HOLDING |
Prescription |
| 10 |
DOFETILIDE |
212496 |
3 |
ANDA |
DOFETILIDE |
CAPSULE;ORAL |
0.5MG |
No |
No |
2026-07-29 |
2026-07-29 |
ANDAS 5 HOLDING |
Prescription |