Application 125117
- Type
- BLA
- Sponsor
- BIOMARIN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAGLAZYME | GALSULFASE | INJECTABLE; INJECTION | 5MG/5ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 68135-020 | NAGLAZYME | galsulfase | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-020 | NAGLAZYME | galsulfase | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-020 | NAGLAZYME | galsulfase | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-020 | NAGLAZYME | galsulfase | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-020 | NAGLAZYME | galsulfase | BioMarin Pharmaceutical Inc. | BLA | Current |
| 68135-020 | NAGLAZYME | galsulfase | BioMarin Pharmaceutical Inc. | BLA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79614 | SUPPL | 2024-09-16 |
| 79586 | SUPPL | 2024-09-16 |
| 79078 | SUPPL | 2024-07-15 |
| 79043 | SUPPL | 2024-07-11 |
| 61363 | SUPPL | 2019-12-20 |
| 61329 | SUPPL | 2019-12-18 |
| 39848 | SUPPL | 2013-04-01 |
| 31836 | SUPPL | 2013-03-29 |
| 31835 | SUPPL | 2011-05-05 |
| 31834 | SUPPL | 2011-05-05 |
| 9613 | SUPPL | 2011-05-05 |
| 39847 | SUPPL | 2011-04-29 |
| 39846 | SUPPL | 2011-04-29 |
| 18794 | SUPPL | 2011-04-29 |
| 22785 | ORIG | 2005-09-13 |
| 18793 | ORIG | 2005-06-07 |
| 9612 | ORIG | 2005-06-07 |