Application 207953
- Type
- NDA
- Sponsor
- JANSSEN PRODS
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | YONDELIS | TRABECTEDIN | POWDER;INTRAVENOUS | 1MG/VIAL | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 59676-610 | YONDELIS | Trabectedin | Janssen Products, LP | NDA | Current |
| 59676-610 | YONDELIS | Trabectedin | Janssen Products, LP | NDA | Current |
| 59676-610 | YONDELIS | Trabectedin | Janssen Products, LP | NDA | Current |
| 59676-610 | YONDELIS | Trabectedin | Janssen Products, LP | NDA | Current |