Application 125359
- Type
- BLA
- Sponsor
- JAZZ PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ERWINAZE | asparaginase Erwinia chrysanthemi | INJECTABLE; INJECTION | 10,000IU | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 57902-249 | ERWINAZE | Asparaginase | Jazz Pharmaceuticals, Inc. | BLA | Current |
| 57902-249 | ERWINAZE | Asparaginase | Jazz Pharmaceuticals, Inc. | BLA | Current |
| 57902-249 | ERWINAZE | Asparaginase | Jazz Pharmaceuticals, Inc. | BLA | Current |
| 57902-249 | ERWINAZE | Asparaginase | Jazz Pharmaceuticals, Inc. | BLA | Current |