FdaApplication
NDA 209819
Identifiers
- fda_app_no: NDA209819
Properties
| Property | Value |
|---|---|
| applicant_name | INDIVIOR INC |
| application_type | NDA |
| approval_date | 2017-11-30 |
Revenue by product
SUBLOCADE
| Period | Revenue |
|---|---|
| Q2 2026 | $253.0M |
| Q1 2026 | $232.0M |
| Q4 2025 | $252.0M |
| Q3 2025 | $219.0M |
| Q2 2025 | $209.0M |
| Q1 2025 | $176.0M |
| Q4 2024 | $194.0M |
| Q3 2024 | $191.0M |
| Q2 2024 | $192.0M |
| Q1 2024 | $179.0M |
Revenue as this company reported it for this product. A combination product's amount is stated once, for the product, and never divided across its ingredients. A fourth quarter is the reported full year less nine months, since no filing states one.
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SUBLOCADE | BUPRENORPHINE | 100MG/0.5ML (100MG/0.5ML) | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS |
| SUBLOCADE | BUPRENORPHINE | 300MG/1.5ML (200MG/ML) | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS |
2 products