Application 125141
- Type
- BLA
- Sponsor
- GENZYME
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MYOZYME | ALGLUCOSIDASE ALFA | INJECTABLE; IV (INFUSION) | 20MG/KG | No | No |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61917 | SUPPL | 2020-02-19 |
| 61914 | SUPPL | 2020-02-19 |
| 58954 | SUPPL | 2019-06-04 |
| 58909 | SUPPL | 2019-05-31 |
| 18799 | SUPPL | 2014-05-28 |
| 31843 | SUPPL | 2014-05-22 |
| 39853 | SUPPL | 2012-07-13 |
| 31842 | SUPPL | 2012-07-13 |
| 18798 | SUPPL | 2009-01-16 |
| 31841 | SUPPL | 2008-12-24 |
| 22788 | ORIG | 2006-06-21 |
| 9617 | ORIG | 2006-05-02 |
| 18797 | ORIG | 2006-04-28 |