Application 020570
- Type
- NDA
- Sponsor
- LANTHEUS MEDICAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QUADRAMET | SAMARIUM SM-153 LEXIDRONAM PENTASODIUM | INJECTABLE;INJECTION | 50mCi/ML | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 11994-016 | Quadramet | samarium Sm 153 lexidronam | Lantheus Medical Imaging, Inc. | NDA | Current |