Application 210089
- Type
- BLA
- Sponsor
- CIS BIO INTL
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 210089 | Pulmotech MAA | kit for the preparation of technetium Tc-99m albumin aggregated | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PULMOTECH MAA | TECHNETIUM TC99M ALBUMIN AGGREGATED | INJECTABLE;INJECTION | 2MG | Yes | 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 |
|---|---|---|---|---|---|---|
| Pulmotech MAA | KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED | Curium US LLC | a8b7adf0-2c6b-4acd-96d3-a099306951a0 | 2025-10-13 | Warnings, Adverse reactions | BLA210089 69945-139 |
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 |
|---|---|---|---|---|---|
| 69945-139 | Pulmotech MAA | kit for the preparation of technetium Tc 99m albumin aggregated | Curium US LLC | BLA | Current |
| 69945-139 | Pulmotech MAA | kit for the preparation of technetium Tc 99m albumin aggregated | Curium US LLC | BLA | Current |
| 69945-139 | Pulmotech MAA | kit for the preparation of technetium Tc 99m albumin aggregated | Curium US LLC | BLA | Current |