Application 020256
- Type
- NDA
- Sponsor
- LANTHEUS MEDCL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEUROLITE | TECHNETIUM TC-99M BICISATE KIT | INJECTABLE;INJECTION | N/A | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 11994-006 | NEUROLITE | Bicisate dihydrochloride | Lantheus Medical Imaging, Inc. | NDA | Current |
| 11994-006 | NEUROLITE | Bicisate dihydrochloride | Lantheus Medical Imaging, Inc. | NDA | Current |
| 11994-006 | NEUROLITE | Bicisate dihydrochloride | Lantheus Medical Imaging, Inc. | NDA | Current |
| 11994-006 | NEUROLITE | Bicisate dihydrochloride | Lantheus Medical Imaging, Inc. | NDA | Current |