| 35916-1738-1 |
35916-1738 |
HUMAN PRESCRIPTION DRUG |
icosapent ethyl |
icosapent ethyl |
CAPSULE |
ORAL |
20250301 |
N/A |
ANDA |
ANDA217656 |
Softgel Healthcare Private Limited |
ICOSAPENT ETHYL |
.5 g/1 |
240 CAPSULE in 1 BOTTLE (35916-1738-1) |
| 70710-1738-4 |
70710-1738 |
HUMAN PRESCRIPTION DRUG |
icosapent ethyl |
icosapent ethyl |
CAPSULE |
ORAL |
20230804 |
N/A |
ANDA |
ANDA217656 |
Zydus Pharmaceuticals USA Inc. |
ICOSAPENT ETHYL |
.5 g/1 |
240 CAPSULE in 1 BOTTLE (70710-1738-4) |
| 70710-1592-7 |
70710-1592 |
HUMAN PRESCRIPTION DRUG |
icosapent ethyl |
icosapent ethyl |
CAPSULE |
ORAL |
20230804 |
N/A |
ANDA |
ANDA217656 |
Zydus Pharmaceuticals USA Inc. |
ICOSAPENT ETHYL |
1 g/1 |
120 CAPSULE in 1 BOTTLE (70710-1592-7) |
| 35916-1592-1 |
35916-1592 |
HUMAN PRESCRIPTION DRUG |
icosapent ethyl |
icosapent ethyl |
CAPSULE |
ORAL |
20250301 |
N/A |
ANDA |
ANDA217656 |
Softgel Healthcare Private Limited |
ICOSAPENT ETHYL |
1 g/1 |
120 CAPSULE in 1 BOTTLE (35916-1592-1) |