Application 761102
- Type
- BLA
- Sponsor
- SERVIER PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ASPARLAS | CALASPARGASE PEGOL-MKNL | INJECTABLE;INTRAVENOUS | 3750UNITS/5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72694-515 | asparlas | calaspargase pegol | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-515 | asparlas | calaspargase pegol | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-515 | asparlas | calaspargase pegol | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-515 | asparlas | calaspargase pegol | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-515 | asparlas | calaspargase pegol | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-515 | asparlas | calaspargase pegol | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-515 | asparlas | calaspargase pegol | Servier Pharmaceuticals LLC | BLA | Current |
| 72694-515 | asparlas | calaspargase pegol | Servier Pharmaceuticals LLC | BLA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 76703 | SUPPL | 2023-11-30 |
| 76699 | SUPPL | 2023-11-29 |
| 69753 | SUPPL | 2021-12-23 |
| 69742 | SUPPL | 2021-12-22 |
| 63705 | SUPPL | 2020-06-25 |
| 63696 | SUPPL | 2020-06-25 |
| 59922 | SUPPL | 2019-09-06 |
| 59921 | SUPPL | 2019-09-05 |
| 57292 | ORIG | 2019-01-22 |
| 56958 | ORIG | 2018-12-21 |
| 56832 | ORIG | 2018-12-20 |