Application 210526
- Type
- NDA
- Sponsor
- TRIS PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DYANAVEL XR | AMPHETAMINE | TABLET, EXTENDED RELEASE;ORAL | 5MG | No | No |
| 002 | DYANAVEL XR | AMPHETAMINE | TABLET, EXTENDED RELEASE; ORAL | 10MG | No | No |
| 003 | DYANAVEL XR | AMPHETAMINE | TABLET, EXTENDED RELEASE;ORAL | 15MG | No | No |
| 004 | DYANAVEL XR | AMPHETAMINE | TABLET, EXTENDED RELEASE; ORAL | 20MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24478-106 | DYANAVEL XR | amphetamine | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-108 | DYANAVEL XR | amphetamine | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-109 | DYANAVEL XR | amphetamine | NextWave Pharmaceuticals, Inc | NDA | Current |
| 24478-110 | DYANAVEL XR | amphetamine | NextWave Pharmaceuticals, Inc | NDA | Current |
| 27808-106 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-106 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-106 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-108 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-108 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-108 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-109 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-109 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-109 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-110 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-110 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-110 | DYANAVEL XR | amphetamine | Tris Pharma Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83496 | SUPPL | 2025-09-25 |
| 83495 | SUPPL | 2025-09-25 |
| 83452 | SUPPL | 2025-09-25 |
| 75789 | SUPPL | 2023-10-17 |
| 75769 | SUPPL | 2023-10-16 |
| 72352 | SUPPL | 2022-10-17 |
| 71213 | SUPPL | 2022-06-06 |
| 71204 | SUPPL | 2022-06-02 |
| 70567 | ORIG | 2022-03-21 |
| 70380 | SUPPL | 2022-03-02 |
| 70379 | SUPPL | 2022-03-02 |
| 70296 | SUPPL | 2022-02-28 |
| 69271 | ORIG | 2021-11-08 |
| 69270 | ORIG | 2021-11-08 |
| 69269 | ORIG | 2021-11-08 |