Application 761094
- Type
- BLA
- Sponsor
- DOMPE FARMACEUTICI
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 761094 | Oxervate | cenegermin-bkbj | 351(a) | Rx | 2026-10-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | OXERVATE | CENEGERMIN-BKBJ | SOLUTION;OPHTHALMIC | 0.002%(20MCG/ML) | No | 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 10 matching rows.
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 75909 | SUPPL | 2023-10-24 |
| 75908 | SUPPL | 2023-10-24 |
| 75896 | SUPPL | 2023-10-24 |
| 75895 | SUPPL | 2023-10-24 |
| 60761 | SUPPL | 2019-10-31 |
| 60753 | SUPPL | 2019-10-31 |
| 55531 | ORIG | 2018-09-20 |
| 55310 | ORIG | 2018-08-24 |
| 55276 | ORIG | 2018-08-23 |