Application 761051
- Type
- BLA
- Sponsor
- KYOWA KIRIN
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761051 | Poteligeo | mogamulizumab-kpkc | 351(a) | Rx | 2026-10-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | POTELIGEO | MOGAMULIZUMAB-KPKC | INJECTABLE;INJECTION | 20MG/5ML | Yes | No |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 7 matching rows.
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85137 | SUPPL | 2026-02-24 |
| 85100 | SUPPL | 2026-02-23 |
| 80917 | SUPPL | 2025-02-04 |
| 80911 | SUPPL | 2025-02-04 |
| 70674 | SUPPL | 2022-03-31 |
| 70668 | SUPPL | 2022-03-31 |
| 68070 | SUPPL | 2021-07-13 |
| 68040 | SUPPL | 2021-07-12 |
| 55394 | ORIG | 2018-09-07 |
| 55133 | ORIG | 2018-08-08 |
| 55132 | ORIG | 2018-08-08 |