Application 017881
- Type
- BLA
- Sponsor
- DRAXIMAGE
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 017881 | Draximage MAA | kit for the preparation of technetium Tc-99m albumin aggregated | 351(a) | Rx | 2026-08-01 |
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 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| DRAXIMAGE MAA | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED | Jubilant DraxImage Inc | bbefaa05-1dc0-3ae7-7264-ce1eddf0da2b | 2024-02-13 | Warnings, Adverse reactions | BLA017881 65174-270 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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. | NDA | Current |
| 65174-270 | DRAXIMAGE MAA | Kit for the Preparation of Technetium Tc 99m Albumin Aggregated | Jubilant DraxImage Inc. | BLA | Current |