| 64896-402-01 |
64896-402 |
HUMAN PRESCRIPTION DRUG |
ONGENTYS |
opicapone |
CAPSULE |
ORAL |
20240405 |
N/A |
NDA |
NDA212489 |
Amneal Pharmaceuticals LLC |
OPICAPONE |
25 mg/1 |
30 CAPSULE in 1 BOTTLE (64896-402-01) |
| 64896-403-01 |
64896-403 |
HUMAN PRESCRIPTION DRUG |
ONGENTYS |
opicapone |
CAPSULE |
ORAL |
20240405 |
N/A |
NDA |
NDA212489 |
Amneal Pharmaceuticals LLC |
OPICAPONE |
50 mg/1 |
30 CAPSULE in 1 BOTTLE (64896-403-01) |
| 64896-403-02 |
64896-403 |
HUMAN PRESCRIPTION DRUG |
ONGENTYS |
opicapone |
CAPSULE |
ORAL |
20240405 |
N/A |
NDA |
NDA212489 |
Amneal Pharmaceuticals LLC |
OPICAPONE |
50 mg/1 |
7 CAPSULE in 1 BOTTLE (64896-403-02) |
| 64896-403-03 |
64896-403 |
HUMAN PRESCRIPTION DRUG |
ONGENTYS |
opicapone |
CAPSULE |
ORAL |
20240405 |
N/A |
NDA |
NDA212489 |
Amneal Pharmaceuticals LLC |
OPICAPONE |
50 mg/1 |
30 CAPSULE in 1 BOTTLE (64896-403-03) |