Application 210136
- Type
- NDA
- Sponsor
- BRAEBURN PHARMA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BRIXADI | BUPRENORPHINE | INJECTION, EXTENDED RELEASE;SUBCUTANEOUS | 8MG | No | No |
| 002 | BRIXADI | BUPRENORPHINE | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 16MG/0.32ML (50MG/ML) | Yes | Yes |
| 003 | BRIXADI | BUPRENORPHINE | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 24MG/0.48ML (50MG/ML) | Yes | Yes |
| 004 | BRIXADI | BUPRENORPHINE | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 32MG/0.64ML (50MG/ML) | Yes | Yes |
| 005 | BRIXADI | BUPRENORPHINE | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 64MG/0.18ML (356MG/ML) | Yes | Yes |
| 006 | BRIXADI | BUPRENORPHINE | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 96MG/0.27ML (356MG/ML) | Yes | Yes |
| 007 | BRIXADI | BUPRENORPHINE | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 128MG/0.36ML (356MG/ML) | Yes | Yes |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85203 | SUPPL | 2026-03-02 |
| 84642 | SUPPL | 2026-01-05 |
| 84585 | SUPPL | 2025-12-29 |
| 83284 | SUPPL | 2025-09-04 |
| 81895 | SUPPL | 2025-04-09 |
| 77924 | ORIG | 2024-03-25 |
| 77049 | SUPPL | 2023-12-19 |
| 77044 | SUPPL | 2023-12-19 |
| 74355 | ORIG | 2023-11-06 |
| 74358 | ORIG | 2023-05-23 |
| 74357 | ORIG | 2023-05-23 |
| 57788 | ORIG | 2019-02-22 |