Application 017881
- Type
- BLA
- Sponsor
- DRAXIMAGE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT | TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT | INJECTABLE;INJECTION | N/A | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65174-270 | DRAXIMAGE MAA | Kit for the Preparation of Technetium Tc 99m Albumin Aggregated | Jubilant DraxImage Inc., dba Jubilant Radiopharma | BLA | Current |
| 65174-270 | DRAXIMAGE MAA | Kit for the Preparation of Technetium Tc 99m Albumin Aggregated | Jubilant DraxImage Inc. | BLA | Current |
| 65174-270 | DRAXIMAGE MAA | Kit for the Preparation of Technetium Tc 99m Albumin Aggregated | Jubilant DraxImage Inc. | NDA | Current |