Application 103411
- Type
- BLA
- Sponsor
- SIGMA TAU
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ONCASPAR | PEGASPARGASE | VIAL | 750IU/VIAL | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0944-3810 | ONCASPAR | Pegaspargase | Baxalta US Inc. | BLA | Current |
| 0944-3810 | ONCASPAR | Pegaspargase | Baxalta US Inc. | BLA | Current |
| 72694-954 | ONCASPAR | Pegaspargase | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-954 | ONCASPAR | Pegaspargase | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-954 | ONCASPAR | Pegaspargase | Servier Pharmaceuticals | BLA | Current |
| 72694-954 | ONCASPAR | Pegaspargase | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-954 | ONCASPAR | Pegaspargase | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-954 | ONCASPAR | Pegaspargase | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-954 | ONCASPAR | Pegaspargase | Servier Pharmaceuticals LLC | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 77828 | SUPPL | 2024-03-14 |
| 77825 | SUPPL | 2024-03-14 |
| 73049 | SUPPL | 2022-12-27 |
| 73022 | SUPPL | 2022-12-23 |
| 69222 | SUPPL | 2021-11-03 |
| 69213 | SUPPL | 2021-11-03 |
| 63639 | SUPPL | 2020-06-19 |
| 63611 | SUPPL | 2020-06-18 |
| 57410 | SUPPL | 2019-02-04 |
| 57193 | SUPPL | 2019-01-11 |
| 45606 | SUPPL | 2016-10-12 |
| 45527 | SUPPL | 2016-10-12 |
| 18580 | SUPPL | 2014-04-23 |
| 9387 | SUPPL | 2014-04-23 |
| 18579 | SUPPL | 2011-12-12 |
| 31585 | SUPPL | 2006-08-04 |
| 18578 | SUPPL | 2006-07-24 |