Skip to contentApplication 205836
- Type
- NDA
- Sponsor
- UCB INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | BRIVIACT | BRIVARACETAM | TABLET;ORAL | 10MG | Yes | No |
| 002 | BRIVIACT | BRIVARACETAM | TABLET;ORAL | 25MG | Yes | No |
| 003 | BRIVIACT | BRIVARACETAM | TABLET;ORAL | 50MG | Yes | No |
| 004 | BRIVIACT | BRIVARACETAM | TABLET;ORAL | 75MG | Yes | No |
| 005 | BRIVIACT | BRIVARACETAM | TABLET;ORAL | 100MG | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 50474-370 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-370 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-370 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-370 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-370 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-470 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-470 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-470 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-470 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-470 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-570 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-570 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-570 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-570 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-570 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-670 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-670 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-670 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-670 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-670 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-770 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-770 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-770 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-770 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |
| 50474-770 | Briviact | brivaracetam | UCB, Inc. | NDA | Current |