FdaApplication
NDA 204384
Identifiers
- fda_app_no: NDA204384
Properties
| Property | Value |
|---|---|
| applicant_name | JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP |
| application_type | NDA |
| approval_date | 2012-12-28 |
Products (2)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| SIRTURO | BEDAQUILINE FUMARATE | EQ 100MG BASE | TABLET;ORAL |
| SIRTURO | BEDAQUILINE FUMARATE | EQ 20MG BASE | TABLET;ORAL |
2 products