Application 761094
- Type
- BLA
- Sponsor
- DOMPE FARMACEUTICI
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761094 | Oxervate | cenegermin-bkbj | 351(a) | Rx | 2026-09-01 |
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | OXERVATE | CENEGERMIN-BKBJ | SOLUTION;OPHTHALMIC | 0.002%(20MCG/ML) | 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 |
|---|---|---|---|---|---|---|
| OXERVATE | CENEGERMIN-BKBJ | Domp farmaceutici S.p.A. | 89e4bfec-d710-40ed-8885-5d13ba46b1cd | 2024-12-31 | Warnings, Adverse reactions | BLA761094 71981-020 71981-001 |
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 |
|---|---|---|---|---|---|
| 71981-001 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |
| 71981-001 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |
| 71981-001 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |
| 71981-001 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |
| 71981-001 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |
| 71981-020 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |
| 71981-020 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |
| 71981-020 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |
| 71981-020 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |
| 71981-020 | OXERVATE | cenegermin-bkbj | Domp | BLA | Current |