Application 103786
- Type
- BLA
- Sponsor
- EKR THERAP
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 103786 | Retavase | reteplase | 351(a) | Rx | 2026-06-01 |
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | RETAVASE | RETEPLASE | VIAL | 18.8MG/VIAL | No | No |
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 |
|---|
| 10122-141 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
| 10122-141 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
| 10122-141 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
| 10122-141 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
| 10122-141 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
| 10122-143 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
| 10122-143 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
| 10122-143 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
| 10122-143 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
| 10122-143 | Retavase | reteplase | Chiesi USA, Inc. | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 22749 | ORIG | 2004-03-29 |
| 9458 | ORIG | 2004-03-29 |