Application 208147
- Type
- NDA
- Sponsor
- TRIS PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DYANAVEL XR | AMPHETAMINE | SUSPENSION, EXTENDED RELEASE;ORAL | EQ 2.5MG BASE/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24478-102 | Dyanavel XR | amphetamine | NextWave Pharmaceuticals, Inc | NDA | Current |
| 27808-102 | Dyanavel XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-102 | Dyanavel XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-102 | Dyanavel XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-102 | Dyanavel XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-102 | Dyanavel XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-102 | Dyanavel XR | amphetamine | Tris Pharma Inc | NDA | Current |
| 27808-102 | Dyanavel XR | amphetamine | Tris Pharma Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83494 | SUPPL | 2025-09-25 |
| 83493 | SUPPL | 2025-09-25 |
| 83451 | SUPPL | 2025-09-25 |
| 75786 | SUPPL | 2023-10-17 |
| 75768 | SUPPL | 2023-10-16 |
| 71212 | SUPPL | 2022-06-06 |
| 71203 | SUPPL | 2022-06-02 |
| 70378 | SUPPL | 2022-03-02 |
| 70377 | SUPPL | 2022-03-02 |
| 70295 | SUPPL | 2022-02-28 |
| 57495 | SUPPL | 2019-02-08 |
| 57492 | SUPPL | 2019-02-07 |
| 57491 | SUPPL | 2019-02-07 |
| 48470 | SUPPL | 2017-05-22 |
| 48469 | SUPPL | 2017-05-22 |
| 46759 | SUPPL | 2017-01-10 |
| 46712 | SUPPL | 2017-01-06 |
| 24534 | ORIG | 2016-06-30 |
| 23050 | ORIG | 2016-06-30 |
| 32895 | ORIG | 2015-10-22 |
| 19986 | ORIG | 2015-10-22 |
| 51529 | ORIG | 1900-01-01 |
| 51528 | ORIG | 1900-01-01 |
| 51527 | ORIG | 1900-01-01 |