Application 202067
- Type
- NDA
- Sponsor
- LUNDBECK PHARMS LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ONFI | CLOBAZAM | TABLET;ORAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | ONFI | CLOBAZAM | TABLET;ORAL | 10MG | Yes | No |
| 003 | ONFI | CLOBAZAM | TABLET;ORAL | 20MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 67386-314 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-314 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-314 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-314 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-314 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-314 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-314 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-314 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-315 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-315 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-315 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-315 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-315 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-315 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-315 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |
| 67386-315 | Onfi | clobazam | Lundbeck Pharmaceuticals LLC | NDA | Current |