Application 761094
- Type
- BLA
- Sponsor
- DOMPE FARMACEUTICI
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 |
NDC Listings For This Application#
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 |