Application 125359
- Type
- BLA
- Sponsor
- JAZZ PHARMS INC
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125359 | Erwinaze | asparaginase Erwinia chrysanthemi | 351(a) | Disc | 2026-07-01 |
Application Products#
Product, Drug, Ingredient table| 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 listings for this application page 1 of 1 ยท 4 matching rows.
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 61308 | SUPPL | 2019-12-17 |
| 61279 | SUPPL | 2019-12-16 |
| 9719 | SUPPL | 2016-03-31 |
| 18882 | SUPPL | 2016-03-30 |
| 39937 | SUPPL | 2015-03-27 |
| 9718 | SUPPL | 2014-12-24 |
| 9717 | SUPPL | 2014-03-11 |
| 39936 | SUPPL | 2014-03-10 |
| 44804 | ORIG | 2011-12-28 |
| 43323 | ORIG | 2011-12-28 |
| 9716 | ORIG | 2011-11-21 |
| 18881 | ORIG | 2011-11-18 |