Application 761051
- Type
- BLA
- Sponsor
- KYOWA KIRIN
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761051 | Poteligeo | mogamulizumab-kpkc | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | POTELIGEO | MOGAMULIZUMAB-KPKC | INJECTABLE;INJECTION | 20MG/5ML | 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 |
|---|---|---|---|---|---|---|
| POTELIGEO | MOGAMULIZUMAB-KPKC | Kyowa Kirin, Inc. | e53960ab-42a1-40d1-9c7d-eb013fe7f18f | 2026-03-02 | Warnings, Adverse reactions | BLA761051 42747-761 |
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 |
|---|---|---|---|---|---|
| 42747-761 | POTELIGEO | mogamulizumab-kpkc | Kyowa Kirin, Inc. | BLA | Current |
| 42747-761 | POTELIGEO | mogamulizumab-kpkc | Kyowa Kirin, Inc. | BLA | Current |
| 42747-761 | POTELIGEO | mogamulizumab-kpkc | Kyowa Kirin, Inc. | BLA | Current |
| 42747-761 | POTELIGEO | mogamulizumab-kpkc | Kyowa Kirin, Inc. | BLA | Current |
| 42747-761 | POTELIGEO | mogamulizumab-kpkc | Kyowa Kirin, Inc. | BLA | Current |
| 42747-761 | POTELIGEO | mogamulizumab-kpkc | Kyowa Kirin, Inc. | BLA | Current |
| 42747-761 | POTELIGEO | mogamulizumab-kpkc | Kyowa Kirin, Inc. | BLA | Current |