FdaApplication
NDA 210136
Identifiers
- fda_app_no: NDA210136
Properties
| Property | Value |
|---|---|
| applicant_name | BRAEBURN INC |
| application_type | NDA |
| approval_date | 2023-05-23 |
Products (7)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| BRIXADI | BUPRENORPHINE | 96MG/0.27ML (356MG/ML) | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS |
| BRIXADI | BUPRENORPHINE | 8MG/0.16ML (50MG/ML) | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS |
| BRIXADI | BUPRENORPHINE | 16MG/0.32ML (50MG/ML) | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS |
| BRIXADI | BUPRENORPHINE | 32MG/0.64ML (50MG/ML) | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS |
| BRIXADI | BUPRENORPHINE | 24MG/0.48ML (50MG/ML) | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS |
| BRIXADI | BUPRENORPHINE | 64MG/0.18ML (356MG/ML) | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS |
| BRIXADI | BUPRENORPHINE | 128MG/0.36ML (356MG/ML) | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS |
7 products