| 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 |
DILTIAZEM HYDROCHLORIDE |
218744 |
1 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
120MG |
No |
No |
2026-02-27 |
2026-02-27 |
MACLEODS PHARMS LTD |
Prescription |
| 2 |
DILTIAZEM HYDROCHLORIDE |
218744 |
2 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
180MG |
No |
No |
2026-02-27 |
2026-02-27 |
MACLEODS PHARMS LTD |
Prescription |
| 3 |
DILTIAZEM HYDROCHLORIDE |
218744 |
3 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
240MG |
No |
No |
2026-02-27 |
2026-02-27 |
MACLEODS PHARMS LTD |
Prescription |
| 4 |
DILTIAZEM HYDROCHLORIDE |
218744 |
4 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
300MG |
No |
No |
2026-02-27 |
2026-02-27 |
MACLEODS PHARMS LTD |
Prescription |
| 5 |
DILTIAZEM HYDROCHLORIDE |
218744 |
5 |
ANDA |
DILTIAZEM HYDROCHLORIDE |
CAPSULE, EXTENDED RELEASE;ORAL |
360MG |
No |
No |
2026-02-27 |
2026-02-27 |
MACLEODS PHARMS LTD |
Prescription |
| 6 |
DULOXETINE |
219131 |
1 |
NDA |
DULOXETINE |
CAPSULE, DELAYED RELEASE |
80MG |
No |
No |
2026-02-27 |
2026-02-27 |
ALMATICA PHARMA LLC |
Prescription |
| 7 |
DULOXETINE |
219131 |
2 |
NDA |
DULOXETINE |
CAPSULE, DELAYED RELEASE |
90MG |
No |
No |
2026-02-27 |
2026-02-27 |
ALMATICA PHARMA LLC |
Prescription |
| 8 |
DULOXETINE |
219131 |
3 |
NDA |
DULOXETINE |
CAPSULE, DELAYED RELEASE |
120MG |
No |
No |
2026-02-27 |
2026-02-27 |
ALMATICA PHARMA LLC |
Prescription |
| 9 |
YUVIWEL |
219164 |
1 |
NDA |
NAVEPEGRITIDE |
POWDER;SUBCUTANEOUS |
1.3MG/VIAL |
Yes |
Yes |
2026-02-27 |
2026-02-27 |
ASCENDIS |
Prescription |
| 10 |
YUVIWEL |
219164 |
2 |
NDA |
NAVEPEGRITIDE |
POWDER;SUBCUTANEOUS |
2.8MG/VIAL |
Yes |
Yes |
2026-02-27 |
2026-02-27 |
ASCENDIS |
Prescription |