Application 125422
- Type
- BLA
- Sponsor
- THROMBOGENICS, INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125422 | Jetrea | ocriplasmin | 351(a) | Disc | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | JETREA | OCRIPLASMIN | INJECTABLE; INTRAVITREAL | 2.5MG/ML | No | No |
NDC Listings For This Application#
NDC listings for this application page 1 of 1 ยท 3 matching rows.
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 24856-002 | JETREA | ocriplasmin | ThromboGenics Inc. | BLA | Current |
| 24856-002 | JETREA | ocriplasmin | ThromboGenics Inc. | BLA | Current |
| 24856-002 | JETREA | ocriplasmin | ThromboGenics Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 47302 | SUPPL | 2017-02-23 |
| 47299 | SUPPL | 2017-02-23 |
| 39959 | SUPPL | 2016-03-29 |
| 9746 | SUPPL | 2016-03-29 |
| 31966 | SUPPL | 2014-06-18 |
| 39958 | SUPPL | 2014-06-17 |
| 9745 | ORIG | 2012-12-05 |
| 43329 | ORIG | 2012-12-04 |
| 39957 | ORIG | 2012-10-18 |
| 51420 | ORIG | 1900-01-01 |
| 51419 | ORIG | 1900-01-01 |
| 51418 | ORIG | 1900-01-01 |