Application 212489
- Type
- NDA
- Sponsor
- NEUROCRINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONGENTYS | OPICAPONE | CAPSULE;ORAL | 25MG | No | No |
| 002 | ONGENTYS | OPICAPONE | CAPSULE;ORAL | 50MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70370-3025 | ONGENTYS | opicapone | Neurocrine Biosciences, Inc. | NDA | Current |
| 70370-3050 | ONGENTYS | opicapone | Neurocrine Biosciences, Inc. | NDA | Current |