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 | 2026-06-01 |
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#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 | 2025-02-05 | Warnings, Adverse reactions | BLA761094 71981-020 71981-001 |
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 |